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This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab [MabThera/Rituxan] | Drug | 375mg/m2 iv every 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Adverse Event (AE) - Overall Summary | Data presented include percentage of participants with any AE, any infusion-related AE, any serious adverse event (SAE), any infusion-related SAE (counted separately from SAEs), death, and participants with toxicity as the primary cause for treatment discontinuation. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival - Percentage of Participants With an Event | PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date. |
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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 "Mother Theresa" Hospital Center; Oncology Department | Tirana | 1000 | Albania | |||
| Instituo Lavalle de Oncologia; Hematology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24824768 | Derived | Witzens-Harig M, Foa R, Di Rocco A, van Hazel G, Chamone DF, Rowe JM, Arcaini L, Poddubnaya I, Ho AD, Ivanova V, Vranovsky A, Thurley D, Oertel S. Maintenance with rituximab is safe and not associated with severe or uncommon infections in patients with follicular lymphoma: results from the phase IIIb MAXIMA study. Ann Hematol. 2014 Oct;93(10):1717-24. doi: 10.1007/s00277-014-2103-3. Epub 2014 May 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab 375 Milligrams Per Square Meter (mg/m^2) | Participants received rituximab 375 mg/m^2 intravenously (IV) once every 8 weeks for a total 12 infusions until progression, relapse, start of a new treatment, death, or toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
| Progression-Free Survival - Time to Event | PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date. | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
| Event-Free Survival (EFS) - Percentage of Participants With an Event | The percentage of participants who experienced PD or death or required a next or new lymphoma treatment over a study period of 2 years with 1 year of follow-up. EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date. | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
| Event-Free Survival (EFS) - Time to Event | EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date. | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
| Overall Survival (OS) - Percentage of Participants With an Event | As a measure of overall survival (OS), the percentage of participants who died over the study period of 2 years with 1 year of follow-up. OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact. | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
| Overall Survival (OS) - Time to Event | OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact. | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
| Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event | As a measure of time to NLT (TNLT), the percentage of participants with new lymphoma treatment over a study period of 2 years with 1 year of follow-up. TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made. | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
| Time to NLT - Time to Event | TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made. | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
| Percentage of Participants With Response by Best Response to Study Treatment | Percentage of participants with complete response (CR), unconfirmed CR (CRu), no change, or progressive disease (PD). For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Where possible, assessment of response was based on the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma (NHL). | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
| Percentage of Participants With PR Who Converted to CRu | Percentage of participants with PR or CR(u) conversion while on rituximab maintenance therapy over a study period of 2 years with 1 year of follow-up. For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Assessment and definition of response was based on the International Workshop to Standardize Response Criteria for NHL. | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
| BahÃa Blanca |
| 8001 |
| Argentina |
| Academia Nacional de Medicina; Inst. de Cardiologia | Buenos Aires | 1425 | Argentina |
| Fundaleu; Haematology | Buenos Aires | C1114AAN | Argentina |
| Hospital Churruca Visca; Haematology | Buenos Aires | C1437JCP | Argentina |
| Hospital Jr Vidal; Jefe de Servicio de Clinica Medica/Hematologia | Corrientes | 3400 | Argentina |
| Sanatorio Allende; Haematology | Córdoba | 5000 | Argentina |
| HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto OncologÃa | Córdoba | 5016 | Argentina |
| Hospital General San Martin; Haematology | La Plata | B1904CFS | Argentina |
| Liverpool Hospital; Haematology | Liverpool | New South Wales | 2170 | Australia |
| Wollongong Hospital; Cancer Services | Wollongong | New South Wales | 2500 | Australia |
| Royal Brisbane Hospital; Oncology Department | Brisbane | Queensland | 4006 | Australia |
| Haematology & Oncology Clinics of Australia, Mater Medical Centre | South Brisbane | Queensland | 4101 | Australia |
| Mount Medical Center | Perth | Western Australia | 6000 | Australia |
| University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept | Banja Luka | 88000 | Bosnia and Herzegovina |
| Inst. of Hematology | Kasindo | 71123 | Bosnia and Herzegovina |
| Uni Hospital Mostar | Mostar | 88000 | Bosnia and Herzegovina |
| Clinic of Oncology, University Clinical Center Sarajevo | Sarajevo | 71000 | Bosnia and Herzegovina |
| CEHON | Salvador | Estado de Bahia | 40110-150 | Brazil |
| Nucleo de Oncologia da Bahia - NOB | Salvador, Bahia | Estado de Bahia | 40170-380 | Brazil |
| ONCOMED | Belo Horizonte | Minas Gerais | 30140-083 | Brazil |
| Centro de Tratamento Oncologico - Oncoclinica | Rio de Janeiro | Rio de Janeiro | 22640-000 | Brazil |
| Hospital das Clinicas - UFRGS; Medicina Interna | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| 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 |
| Hospital das Clinicas - UNICAMP; Hemoterapia | Campinas | São Paulo | 13083-878 | Brazil |
| Clinica Oncologica De Piracicaba Sc | Piracicaba | São Paulo | 13419-155 | Brazil |
| Hospital Alemao Oswaldo Cruz; Oncologia | São Paulo | São Paulo | 01323-020 | Brazil |
| Hospital Estadual do Servidor Publico; Hematologia | São Paulo | São Paulo | 04029-000 | Brazil |
| Hospital das Clinicas - FMUSP, Oncologia | São Paulo | São Paulo | 05403-000 | Brazil |
| UMHAT Dr Georgi Stranski; Hematology | Pleven | 5800 | Bulgaria |
| Umhat S. George; Hematology | Plovdiv | 4002 | Bulgaria |
| UMHAT Alexandrovska EAD; Hematology | Sofia | 1431 | Bulgaria |
| National Center of Hematology & Transfusiology; Clinical Unit, Clinic of Hematology | Sofia | 1757 | Bulgaria |
| Mhat Sveta Marina; Dept. of Haematology | Varna | 9010 | Bulgaria |
| Centro Médico Carlos Ardila Lule | Bucaramanga | Colombia |
| Hospital Pablo Tobon Uribe | Medellin-Antioquia | Colombia |
| Clinical Hospital Centre Split; Dept Of Hematology | Split | 21000 | Croatia |
| Clinical Hospital Centre Dubrava; Hematology Department | Zagreb | 10000 | Croatia |
| University Hospital Center Zagreb; Haematology Department | Zagreb | 10000 | Croatia |
| Hospital José Carrasco; Oncology Service | Cuenca | Ecuador |
| Hospital Carlos Andrade Marin; Servicio de OncologÃa | Quito | 2569 | Ecuador |
| Oncology & Radiotherapy Centre; Oncology | Cairo | 11737 | Egypt |
| Kanta-Hämeen Keskussairaala; Dept of Internal Medicine, Hematology | Hämeenlinna | 13530 | Finland |
| Kymenlaakson keskussairaala | Kotka | 48210 | Finland |
| Päijät-Hämeen Keskussairaala; Dept of Internal Medicine, Hematology | Lahti | 15850 | Finland |
| Satakunnan Keskussairaala; Sisaetauti Osasto | Pori | 28500 | Finland |
| Internist; Praxis Für Haemotologie & Onkologie | Bad Soden | 65812 | Germany |
| Dres.Christian Sperling und Claudia Schelenz | Berlin | 10117 | Germany |
| Onkologische Schwerpunktpraxis Kurfürstendamm | Berlin | 10707 | Germany |
| Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin | Bonn | 53127 | Germany |
| Dres. Matthias Adler Oliver Marschal und Andreas Pies | Braunschweig | 38100 | Germany |
| Gemeinschaftspraxis | Duisburg | 47051 | Germany |
| Internistische Praxis Dr. Plingen | Düsseldorf | 40211 | Germany |
| Internistische Schwerpunktpraxis Erlangen | Erlangen | 91052 | Germany |
| Praxis für Interdisziplinäre Onkologie und Hämatologie GbR | Freiburg im Breisgau | 79110 | Germany |
| Onkologische Gemeinschaftspraxis, Prof. Dr. Gropp, Dr. Depenbusch und Dr. Rösel | Gütersloh | 33332 | Germany |
| Überörtliche Gemeinschaftspraxis Schwerpunkt Hämatologie, internistische Onkologie & Palliativmed. | Hamburg | 20259 | Germany |
| Onkologische Schwerpunktpraxis; Herrn Dr. Med. Bertram | Hamburg | 22457 | Germany |
| Dres.Andreas Karcher und Stefan Fuxius | Heidelberg | 69115 | Germany |
| Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V | Heidelberg | 69120 | Germany |
| Onkologische Schwerpunktpraxis (Eps-Gmbh) | Jena | 07743 | Germany |
| Märkische Kliniken GmbH, Klinikum Lüdenscheid; Hämatologie / Onkologie | Lüdenscheid | 58515 | Germany |
| Stauferklinikum Schwäb.Gmünd | Mutlangen | 73557 | Germany |
| Gemeinschaftspraxis Dres. Schröder, Sieg | Mülheim | 45468 | Germany |
| Onko. Gemeinschaftspraxis Dres. Tigges/ Böning/ Abenhardt/ Bosse | München | 80335 | Germany |
| Dres.Ulrich Hutzschenreuter und Uwe Sauer | Nordhorn | 48527 | Germany |
| Onkologische Praxis Oldenburg; Dres. Otremba, Reschke, Zirpel, Kühn und Ruff | Oldenburg | 26121 | Germany |
| Praxis für Onkologie und Hämatologie | Recklinghausen | 45657 | Germany |
| Diakonie-Klinikum Klinik für Innere Medizin III Abt.Hämatologie, intern. Onkologie und Palliativmedi | Schwäbisch Hall | 74523 | Germany |
| Internistische Gemeinschaftspraxis Dres. Hoering/Von Ehr/Responde | Stuttgart | 70176 | Germany |
| Haematologisch-Onkologische Praxis; Dr. med. Christoph Maintz und Matthias Groschek | Würselen | 52146 | Germany |
| Laiko General Hospital - Uni of Athens; 1St Dept. of Internal Medicine | Athens | 11524 | Greece |
| Attiko Hospital; Haematology Clinic | Athens | 124 62 | Greece |
| Theagenio Anticancer Hospital; Dept. of Haematology | Thessaloniki | 54007 | Greece |
| Rambam Medical Center; Heamatology & Bone Marrow Transplantation | Haifa | 3109601 | Israel |
| Wolfson Mc; Haematology | Holon | 5810001 | Israel |
| Hadassah Ein Karem Hospital; Haematology | Jerusalem | 9112001 | Israel |
| Chaim Sheba Medical Center; Hematology BMT & CBB | Ramat Gan | 52662 | Israel |
| Ichilov Sourasky Medical Center; Heamatology | Tel Aviv | 6423906 | Israel |
| Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia | Pescara | Abruzzo | 65100 | Italy |
| Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica | Bari | Apulia | 70124 | Italy |
| Ospedale Vito Fazzi; Div. Oncoematologia | Lecce | Apulia | 73100 | Italy |
| Az. Osp. C. Panico; Rep. Ematologia E Trapianto | Tricase - Le | Apulia | 73039 | Italy |
| Az. Osp. Pugliese; Dh Oncologico | Catanzaro | Calabria | 88100 | Italy |
| Ospedale S. Gennaro; Divisione Di Ematologia | Naples | Campania | 80100 | Italy |
| Ospedale Cardarelli; Divisione Di Ematologia | Naples | Campania | 80131 | Italy |
| A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna | Bologna | Emilia-Romagna | 40138 | Italy |
| Arcispedale S. Anna; Sezione Di Ematologia | Ferrara | Emilia-Romagna | 44100 | Italy |
| A.O. Universitaria Policlinico Di Modena; Ematologia | Modena | Emilia-Romagna | 41100 | Italy |
| A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica | Modena | Emilia-Romagna | 41100 | Italy |
| Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica | Aviano | Friuli Venezia Giulia | 33081 | Italy |
| Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia | Rome | Lazio | 00133 | Italy |
| Ospedale S. Eugenio; Divisione Di Ematologia | Rome | Lazio | 00144 | Italy |
| Univ. Cattolica La Sapienza; Cattedra Di Ematologia | Rome | Lazio | 00161 | Italy |
| Uni Cattolica; Divisione Di Ematologia | Rome | Lazio | 00168 | 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 |
| Istituto S. Raffaele Monte Tabor; Divisione Ematologia E Utmo | Milan | Lombardy | 20132 | Italy |
| Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico | Milan | Lombardy | 20133 | Italy |
| Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia | Milan | Lombardy | 20162 | Italy |
| ASST DI MONZA; Ematologia | Monza | Lombardy | 20052 | Italy |
| Irccs Policlinico San Matteo; Divisione Di Ematologia | Pavia | Lombardy | 27100 | Italy |
| Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico | Candiolo | Piedmont | 10060 | Italy |
| Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia | Cuneo | Piedmont | 12100 | Italy |
| Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad | Novara | Piedmont | 28100 | 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 |
| Ospedale Oncologico A Businco-Cagliari; Ematologia Sez. | Cagliari | Sardinia | 09121 | Italy |
| Ospedale V. Cervello; U.O. Ematologia E Trapianti | Palermo | Sicily | 90146 | Italy |
| Ospedale Ferrarotto; Divisione Di Ematologia | Via S. Sofia 78 | Sicily | 95123 | Italy |
| Ospedale Civile; S.C. Ematologia | Pesaro | The Marches | 61100 | Italy |
| A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia | Torrette Di Ancona | The Marches | 60020 | Italy |
| Az. Osp. Di Careggi; Divisione Di Ematologia | Florence | Tuscany | 50135 | Italy |
| Ospedale Santa Chiara; Unita Operativa Di Ematologia | Pisa | Tuscany | 56100 | Italy |
| A.O. Universitaria Senese; Ematologia | Siena | Tuscany | 53100 | Italy |
| Azienda Ospedaliera S. Maria della Misericordia; Ematologia | Perugia | Umbria | 06100 | Italy |
| Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia | Padova | Veneto | 35128 | Italy |
| Ospedale Di Vicenza; Nefrologia, Ematologia | Vicenza | Veneto | 36100 | Italy |
| Issste; Haematology | Chihuahua City | 31100 | Mexico |
| Hospital Cima (Centro Internacional de Medicina) ; Haematology | Chihuahua City | 31238 | Mexico |
| Hospital Central de Pemex Norte Azcapotzalco | Mexico City | 02720 | Mexico |
| Hospital Español de Mexico | Mexico City | 11520 | Mexico |
| Hospital Regional Issste; Oncologia | Monterrey | 64380 | Mexico |
| Clinca San Jose; Haematology | Obregón | 85000 | Mexico |
| Issstep Puebla, ; Haematology | Puebla City | 72530 | Mexico |
| Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie | Brasov | 500326 | Romania |
| Fundeni Clinical Inst. ; Hematology Dept | Bucharest | 022328 | Romania |
| Spitalul Clinic Coltea; Clinica de Hematologie | Bucharest | 030171 | Romania |
| Oncology Inst. Cluj-Napoca; Cancer Dept | Cluj-Napoca | 400015 | Romania |
| Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Clinica de Hematologie | Iași | 700111 | Romania |
| Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie | Târgu Mureş | 540136 | Romania |
| Regional Clinical Hospital; Hematology | Belgorod | ND | Russia |
| Clinical Oncology Dispensary of Ministry of Health of Tatarstan | Kazan' | 420029 | Russia |
| Blokhin Cancer Research Center; Clinical Oncology | Moscow | 115478 | Russia |
| City Clinical Hospital After Botkin; Hematology | Moscow | 125101 | Russia |
| Vladimirskiy Regional Scientific Research Inst. ; Hematology | Moscow | 129110 | Russia |
| Regional Clinical Hospital N.A. Semashko; Hematology | Nizhny Novgorod | 603126 | Russia |
| City Hematological Center of Clinical Hospital #2; Hematology | Novosibirsk | 630051 | Russia |
| Rostov State Medical Uni ; Hematology | Rostov-on-Don | 344022 | Russia |
| Research Inst. of Hematology & Blood Transfusion ; Hematology | Saint Petersburg | 191024 | Russia |
| Pavlov State Medical Uni ; Bone Marrow Transplantation Clinic | Saint Petersburg | 197022 | Russia |
| Leningrad Regional Clinical Hospital; Hematology #1 | Saint Petersburg | Russia |
| Stavropol Clinical Oncology Dispansary | Stavropol | ND | Russia |
| Bashkirian Republican Clinical Oncology Dispensary | Ufa | 450054 | Russia |
| Ulyanovsk Regional Oncology Dispensary; Chemotherapy | Ulyanovsk | ND | Russia |
| Regional Oncology Center; Chemotherapy | Volgograd | 400138 | Russia |
| Regional Clinical Hospital; Hematology | Yaroslavl | 150062 | Russia |
| Fakultna Nemocnica Roosevelta; Dept. of Haematology | Banská Bystrica | 975 17 | Slovakia |
| National Oncology Inst. ; Dept. of Haematology | Bratislava | 833 10 | Slovakia |
| Uni Hospital; Clinic of Haematology | Košice | 040 66 | Slovakia |
| Uni Hospital ; Dept. of Haematol. & Transfusion Medicine | Martin | 036 59 | Slovakia |
| Institute of Oncology Ljubljana | Ljubljana | 1000 | Slovenia |
| Hospital General de Castellon; Servicio de Hematologia | Castellon | Castellon | 12004 | Spain |
| Complejo Asistencial Universitario De Burgos; Servicio de Oncologia | Burgos | 09006 | Spain |
| Hospital Generla de Ciudad Real; Servicio de Oncologia | Ciudad Real | 13005 | Spain |
| Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia | Jaén | 23007 | Spain |
| Hospital El Bierzo; Servicio de Oncologia | León | 24411 | Spain |
| Hospital Costa del Sol; Servicio de Hematologia | Málaga | 29600 | Spain |
| Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia | Murcia | 30120 | Spain |
| Hospital Universitario Virgen Macarena; Servicio de Hematologia | Seville | 41009 | Spain |
| Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia | Valencia | 46010 | Spain |
| Laenssjukhuset; Medicinkliniken/Hematologsektionen | Halmstad | 30185 | Sweden |
| Sunderby Sjukhus; Medicinkliniken | Luleå | S-971 80 | Sweden |
| Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling | Malmö | 205 02 | Sweden |
| Länssjukhuset Sundsvall-Härnösand, Medicinkliniken | Sundsvall | 85186 | Sweden |
| Uddevalla Sjukhus; Medicinkliniken | Uddevalla | 45180 | Sweden |
| Akademiska sjukhuset, Onkologkliniken | Uppsala | 75185 | Sweden |
| Andreas Klinik; Onko-Hämatologisches Zentrum Cham Zug | Cham | 6330 | Switzerland |
| Kantonsspital Graubünden;Onkologie und Hämatologie | Chur | 7000 | Switzerland |
| Clinica Santa Chiara; Oncologia / Ematologia | Locarno | 6601 | Switzerland |
| UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie | Zurich | 8091 | Switzerland |
| Ankara Numune Egitim Ve Arastirma Hastanesi; Hematoloji Klinigi | Ankara | 06100 | Turkey (Türkiye) |
| Hacettepe Uni Medical Faculty; Hematology | Ankara | 06100 | Turkey (Türkiye) |
| Gazi Uni Medical School; Hematology | Ankara | 06500 | Turkey (Türkiye) |
| Istanbul Uni Capa Hospital; Hematology | Istanbul | 34390 | Turkey (Türkiye) |
| Ege Uni Medical School; Hematology | Izmir | 35100 | Turkey (Türkiye) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population: all participants who completed a baseline visit and at least 1 further assessment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab 375 mg/m^2 | Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With an Adverse Event (AE) - Overall Summary | Data presented include percentage of participants with any AE, any infusion-related AE, any serious adverse event (SAE), any infusion-related SAE (counted separately from SAEs), death, and participants with toxicity as the primary cause for treatment discontinuation. | Safety Population: any participant who received at least 1 dose of study treatment. | Posted | Number | percentage of participants | 24 months |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival - Percentage of Participants With an Event | PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date. | ITT population | Posted | Number | percentage of participants | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival - Time to Event | PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date. | ITT population | Posted | Median | 95% Confidence Interval | months | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Event-Free Survival (EFS) - Percentage of Participants With an Event | The percentage of participants who experienced PD or death or required a next or new lymphoma treatment over a study period of 2 years with 1 year of follow-up. EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date. | ITT population | Posted | Number | percentage of participants | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Event-Free Survival (EFS) - Time to Event | EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date. | ITT population | Posted | Median | 95% Confidence Interval | months | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) - Percentage of Participants With an Event | As a measure of overall survival (OS), the percentage of participants who died over the study period of 2 years with 1 year of follow-up. OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact. | ITT population | Posted | Number | percentage of participants | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) - Time to Event | OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact. | ITT population | Posted | Median | 95% Confidence Interval | percentage of participants | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event | As a measure of time to NLT (TNLT), the percentage of participants with new lymphoma treatment over a study period of 2 years with 1 year of follow-up. TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made. | ITT population | Posted | Number | percentage of participants | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time to NLT - Time to Event | TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made. | ITT population | Posted | Median | 95% Confidence Interval | months | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Response by Best Response to Study Treatment | Percentage of participants with complete response (CR), unconfirmed CR (CRu), no change, or progressive disease (PD). For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Where possible, assessment of response was based on the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma (NHL). | ITT population; only participants who received any study treatment were included in the analysis. | Posted | Number | percentage of participants | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With PR Who Converted to CRu | Percentage of participants with PR or CR(u) conversion while on rituximab maintenance therapy over a study period of 2 years with 1 year of follow-up. For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Assessment and definition of response was based on the International Workshop to Standardize Response Criteria for NHL. | ITT population; only participants with PR to most recent treatment were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose |
|
|
AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
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 375 mg/m^2 | Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity. | 109 | 534 | 207 | 534 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident - IRR | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Aspergilloma | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cerebral aspergillosis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Meningitis enteroviral | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Coeliac disease | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Palpitation | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Metastatic gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Osteosarcoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Thalamus haemorrhage | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Female sterilisation | Surgical and medical procedures | MedDRA (10.1) | Non-systematic Assessment |
| |
| Finger amputation | Surgical and medical procedures | MedDRA (10.1) | Non-systematic Assessment |
| |
| Inguinal hernia repair | Surgical and medical procedures | MedDRA (10.1) | Non-systematic Assessment |
| |
| Small intestinal resection | Surgical and medical procedures | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Vascular occlusion | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pregnancy of partner | Social circumstances | MedDRA (10.1) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (10.1) | Non-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-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| 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 |
| 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 |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Any infusion-related SAE |
|
| Deaths |
|
| Toxicity as primary cause for discontinuation |
|
|
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