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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003230-17 | EudraCT Number |
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This multi-center, open-label, randomized study will evaluate the participant preference with subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV) on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4, followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8 cycles of standard chemotherapy (according to local country practice) with 8 cycles of MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. |
|
| Arm B | Experimental | Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP) | Drug | Standard chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6 | Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6. | Cycle 6 (Up to 24 weeks) |
| Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8 | Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing Cycle 8. | Cycle 8 (Up to 32 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Randomization of first participant to clinical cutoff date (Up to 4 years) |
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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 |
|---|---|---|---|---|---|---|
| Buenos Aires | 1425 | Argentina | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28031173 | Derived | Rummel M, Kim TM, Aversa F, Brugger W, Capochiani E, Plenteda C, Re F, Trask P, Osborne S, Smith R, Grigg A. Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol. 2017 Apr 1;28(4):836-842. doi: 10.1093/annonc/mdw685. | |
| 27695295 |
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A total of 743 participants were enrolled across all the sites and were included in the intent to treat (ITT) population. Three participants were enrolled but died prior to receiving study medication and were not included in the safety population. The Participant Flow represents the safety population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | Participants in Arm A received one cycle of rituximab 375 milligram per metre square (mg/m^2) intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP) | Drug | Standard chemotherapy |
|
| Bendamustine | Drug | Standard chemotherapy |
|
|
| Rituximab | Drug | 1400 mg subcutaneously (SC), Day 1 Cycles 2-4 |
|
|
| Rituximab | Drug | 375 mg/m2 IV, Day 1 Cycles 1-4 |
|
|
| Rituximab | Drug | 375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8 |
|
|
| Rituximab | Drug | 1400 mg SC, Day 1 Cycles 5-8 |
|
|
| Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV]) | Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion | Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks) |
| Cancer Therapy Satisfaction Questionnaire (CTSQ) Score | CTSQ is a validated 16-item questionnaire that measures three domains related to participants' satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. | During Cycle 4, 8 of treatment (Up to 32 weeks) |
| Rituximab Administration Satisfaction Questionnaire (RASQ) Score | The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. | During Cycle 4, 8 of treatment (Up to 32 weeks) |
| Complete Response (CR) Rate | CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study. | 28 days (± 3 days) after Day 1 of the last dose of induction treatment |
| Event-free Survival (EFS) | EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (<=) 1.0 × <= 1.0 cm would not be considered as abnormal for PD. | From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years) |
| Disease-free Survival (DFS) | DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first. | From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years) |
| Progression-free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes <= 1.0 × <= 1.0 cm would not be considered as abnormal for PD. | From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years) |
| Overall Survival (OS) | OS was defined as the time from randomization to death from any cause. | From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years) |
| Percentage of Participants With Anti-Rituximab Antibodies Over Time | Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years) |
| Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time | Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years) |
| Summary of Observed Serum Rituximab Concentration | Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years) |
| Corrientes |
| 3400 |
| Argentina |
| Santa Fe | 3000 | Argentina |
| Canberra | Australian Capital Territory | 2605 | Australia |
| Camperdown | New South Wales | 2050 | Australia |
| Liverpool | New South Wales | 2170 | Australia |
| Randwick | New South Wales | 2031 | Australia |
| Brisbane | Queensland | 4101 | Australia |
| Adelaide | South Australia | 5000 | Australia |
| Hobart | Tasmania | 7000 | Australia |
| Geelong | Victoria | 3220 | Australia |
| Malvern | Victoria | 3144 | Australia |
| Melbourne | Victoria | 3084 | Australia |
| Wodonga | Victoria | 3690 | Australia |
| Nedlands | Western Australia | 6009 | Australia |
| Perth | Western Australia | 6000 | Australia |
| Krems | 3500 | Austria |
| Linz | 4020 | Austria |
| Salzburg | 5020 | Austria |
| Steyr | 4400 | Austria |
| Vienna | 1140 | Austria |
| Belo Horizonte | Minas Gerais | 30150-320 | Brazil |
| Juiz de Fora | Minas Gerais | 36010-510 | Brazil |
| Varginha | Minas Gerais | 37062-770 | Brazil |
| Curitiba | Paraná | 81520-060 | Brazil |
| Londrina | Paraná | 86050-190 | Brazil |
| Recife | Pernambuco | 50070-550 | Brazil |
| Caxias do Sul | Rio Grande do Sul | 95070-560 | Brazil |
| Novo Hamburgo | Rio Grande do Sul | 93510-250 | Brazil |
| Santa Maria | Rio Grande do Sul | 97015-373 | Brazil |
| Santo André | São Paulo | 09060-650 | Brazil |
| São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Burnaby | British Columbia | V5G 2X6 | Canada |
| Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Victoria | British Columbia | V8R 6V5 | Canada |
| Hamilton | Ontario | L8V 5C2 | Canada |
| Montreal | Quebec | H1T 2M4 | Canada |
| Santiago | 8380000 | Chile |
| Santiago | 8420383 | Chile |
| Viña del Mar | 2520612 | Chile |
| Montería | Colombia |
| Osijek | 31000 | Croatia |
| Aalborg | 9000 | Denmark |
| Holstebro | 7500 | Denmark |
| Santiago de los Caballeros | 51000 | Dominican Republic |
| Alexandria | 11737 | Egypt |
| Cairo | 11562 | Egypt |
| San Salvador | 1101 | El Salvador |
| Aschaffenburg | 63739 | Germany |
| Augsburg | 86150 | Germany |
| Bamberg | 96049 | Germany |
| Bayreuth | 95445 | Germany |
| Berlin | 10559 | Germany |
| Berlin | 10967 | Germany |
| Berlin | 12351 | Germany |
| Berlin | 13581 | Germany |
| Bielefeld | 33604 | Germany |
| Bielefeld | 33611 | Germany |
| Bochum | 44787 | Germany |
| Bochum | 44791 | Germany |
| Bonn | 53127 | Germany |
| Bottrop | 46236 | Germany |
| Brandenburg | 14770 | Germany |
| Bremen | 28177 | Germany |
| Bremerhaven | 27568 | Germany |
| Coesfeld | 48653 | Germany |
| Cologne | 50677 | Germany |
| Darmstadt | 64283 | Germany |
| Darmstadt | 64295 | Germany |
| Dresden | 01127 | Germany |
| Dresden | 01307 | Germany |
| Düsseldorf | 40225 | Germany |
| Eisenach | 99817 | Germany |
| Essen | 45122 | Germany |
| Essen | 45239 | Germany |
| Frankfurt | 60389 | Germany |
| Frankfurt | 60488 | Germany |
| Frankfurt | 60596 | Germany |
| Frankfurt (Oder) | 15236 | Germany |
| Freiburg im Breisgau | 79110 | Germany |
| Fürth | 90766 | Germany |
| Georgsmarienhütte | 49124 | Germany |
| Giessen | 35392 | Germany |
| Giessen | Germany |
| Goslar | 38642 | Germany |
| Gütersloh | 33332 | Germany |
| Halle | 06110 | Germany |
| Hamburg | 20246 | Germany |
| Hamburg | 22081 | Germany |
| Hamburg | 22457 | Germany |
| Hamm | 59063 | Germany |
| Hamm | 59071 | Germany |
| Hanau | 63450 | Germany |
| Hanover | 30171 | Germany |
| Hanover | 30625 | Germany |
| Herford | 32049 | Germany |
| Jena | 07747 | Germany |
| Kaiserslautern | 67655 | Germany |
| Kassel | 34125 | Germany |
| Leer | 26789 | Germany |
| Leipzig | 04289 | Germany |
| Limburg | 65549 | Germany |
| Lübeck | 23562 | Germany |
| Magdeburg | 39104 | Germany |
| Mainz | 55122 | Germany |
| Mannheim | 68161 | Germany |
| Marburg | 35037 | Germany |
| Mayen | 56727 | Germany |
| Moers | 47441 | Germany |
| Mönchengladbach | 41239 | Germany |
| Mutlangen | 73557 | Germany |
| Mülheim | 45468 | Germany |
| München | 80804 | Germany |
| Münster | 48149 | Germany |
| Neunkirchen/Saar | 66538 | Germany |
| Nuremberg | 90449 | Germany |
| Oldenburg | 26121 | Germany |
| Osnabrück | 49076 | Germany |
| Paderborn | 33098 | Germany |
| Pforzheim | 75179 | Germany |
| Pinneberg | 25421 | Germany |
| Pirna | 01796 | Germany |
| Porta Westfalica | 32457 | Germany |
| Pößneck | 07381 | Germany |
| Ravensburg | 88212 | Germany |
| Recklinghausen | 45657 | Germany |
| Regensburg | 93053 | Germany |
| Rostock | 18055 | Germany |
| Rostock | 18057 | Germany |
| Rostock | 18059 | Germany |
| Rostock | 18107 | Germany |
| Rötha | 04571 | Germany |
| Schwäbisch Hall | 74523 | Germany |
| Schweinfurt | 97422 | Germany |
| Siegburg | 53721 | Germany |
| Stade | 21680 | Germany |
| Stendal | 39576 | Germany |
| Stuttgart | 70173 | Germany |
| Traunstein | 83278 | Germany |
| Trier | 54290 | Germany |
| Velbert | 42551 | Germany |
| Villingen-Schwenningen | 78052 | Germany |
| Weilheim | 82362 | Germany |
| Wiesbaden | 65191 | Germany |
| Wilhelmshaven | 26382 | Germany |
| Witten | 58452 | Germany |
| Würselen | 52146 | Germany |
| Zittau | 02763 | Germany |
| Zwickau | 08060 | Germany |
| Guatemala City | 01-010 | Guatemala |
| Guatemala City | 01010 | Guatemala |
| Hong Kong | 852 | Hong Kong |
| Hong Kong | Hong Kong |
| Budapest | 1097 | Hungary |
| Győr | 9024 | Hungary |
| Gyula | 5700 | Hungary |
| Kaposvár | 7400 | Hungary |
| Nyíregyháza | 4400 | Hungary |
| Szeged | 6720 | Hungary |
| Szolnok | 5004 | Hungary |
| Bandung | 40161 | Indonesia |
| Jakarta | 11420 | Indonesia |
| Surabaya | 60111 | Indonesia |
| Yogyakarta | 55284 | Indonesia |
| Brindisi | Apulia | 72100 | Italy |
| Lecce | Apulia | 73100 | Italy |
| Catanzaro | Calabria | 88100 | Italy |
| Ferrara | Emilia-Romagna | 44100 | Italy |
| Parma | Emilia-Romagna | 43126 | Italy |
| Piacenza | Emilia-Romagna | 29121 | Italy |
| Rome | Lazio | 00133 | Italy |
| Candiolo | Piedmont | 10060 | Italy |
| Cuneo | Piedmont | 12100 | Italy |
| Palermo | Sicily | 90146 | Italy |
| Lido di Camaiore | Tuscany | 55041 | Italy |
| Livorno | Tuscany | 57124 | Italy |
| Ampang | 68000 | Malaysia |
| Kuala Lumpur | 56000 | Malaysia |
| Kuching | 93586 | Malaysia |
| Sabak Bernam | 88586 | Malaysia |
| Amstelveen | 1186 AH | Netherlands |
| Amsterdam | 1091 AC | Netherlands |
| Apeldoorn | 7334 DZ | Netherlands |
| Beverwijk | 1942 LE | Netherlands |
| Capelle aan den IJssel | 2906 ZC | Netherlands |
| Delftzijl | 9934 JD | Netherlands |
| Eindhoven | 5623 EJ | Netherlands |
| Goes | 4462 RA | Netherlands |
| Leidschendam | 2262 BA | Netherlands |
| Rotterdam | 3045 PM | Netherlands |
| The Hague | 2512 VA | Netherlands |
| The Hague | 2566 MJ | Netherlands |
| Tilburg | 5022 GC | Netherlands |
| Utrecht | 3582 KE | Netherlands |
| Auckland | New Zealand |
| Panama City | 080814 | Panama |
| Panama City | 0832-00752 | Panama |
| Panama City | 0834-02723 | Panama |
| Arequipa | 04001 | Peru |
| Cusco | 08006 | Peru |
| La Victoria, Lima | Lima 13 | Peru |
| Cebu City | 6000 | Philippines |
| Manila | 1000 | Philippines |
| Manila | 1003 | Philippines |
| Quezon City | 1100 | Philippines |
| Lisbon | 1449-005 | Portugal |
| Matosinhos Municipality | 4454-509 | Portugal |
| Ponta Delgada | 9500-370 | Portugal |
| Setúbal | 2910-446 | Portugal |
| Viseu | 3504-509 | Portugal |
| Baia Mare | 430031 | Romania |
| Brasov | 500152 | Romania |
| Brasov | 500326 | Romania |
| Bucharest | 022328 | Romania |
| Bucharest | 030171 | Romania |
| Bucharest | 050098 | Romania |
| Cluj-Napoca | 400015 | Romania |
| Craiova | 200143 | Romania |
| Iași | 700483 | Romania |
| Sibiu | 550245 | Romania |
| Timișoara | 300239 | Romania |
| Busan | 602-739 | South Korea |
| Daegu | 41944 | South Korea |
| Seoul | 03080 | South Korea |
| Seoul | 06591 | South Korea |
| Falun | 79182 | Sweden |
| Gothenburg | S-413 45 | Sweden |
| Jönköping | 551_85 | Sweden |
| Karlstad | 65185 | Sweden |
| Sundsvall | 85186 | Sweden |
| Västerås | SE-71 289 | Sweden |
| Kaohsung | 883 | Taiwan |
| Taichung | 40705 | Taiwan |
| Taipei | 100 | Taiwan |
| Bangkok | 10330 | Thailand |
| Bangkok | 10400 | Thailand |
| Bangkok | 10700 | Thailand |
| Chiang Mai | 50200 | Thailand |
| Khon Kaen | 40002 | Thailand |
| Ankara | 06100 | Turkey (Türkiye) |
| Ankara | 06200 | Turkey (Türkiye) |
| Denizli | 20070 | Turkey (Türkiye) |
| Erzurum | 25050 | Turkey (Türkiye) |
| Malatya | 44280 | Turkey (Türkiye) |
| Hà Nội | 70000 | Vietnam |
| Hochiminh City | 70000 | Vietnam |
| Derived |
| Theodore-Oklota C, Humphrey L, Wiesner C, Schnetzler G, Hudgens S, Campbell A. Validation of a treatment satisfaction questionnaire in non-Hodgkin lymphoma: assessing the change from intravenous to subcutaneous administration of rituximab. Patient Prefer Adherence. 2016 Sep 13;10:1767-1776. doi: 10.2147/PPA.S108489. eCollection 2016. |
| FG001 | Arm B | Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. |
| BG001 | Arm B | Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. |
| BG002 | Total | Total of all reporting groups |
| 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 Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6 | Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6. | ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 6 (Up to 24 weeks) |
|
|
| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8 | Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing Cycle 8. | ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 8 (Up to 32 weeks) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | The safety population included all participants who received at least one dose of rituximab. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure. | Posted | Number | participants | Randomization of first participant to clinical cutoff date (Up to 4 years) |
| |||||||||||||||||||||||||||||||
| Secondary | Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV]) | Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion | ITT population included all participants who were randomized in the study. | Posted | Median | Full Range | minutes | Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks) |
| ||||||||||||||||||||||||||||||
| Secondary | Cancer Therapy Satisfaction Questionnaire (CTSQ) Score | CTSQ is a validated 16-item questionnaire that measures three domains related to participants' satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. | ITT population included all participants who were randomized in the study. Here, "Number Analyzed" represents the number of participants who were evaluable at specified time points. | Posted | Mean | Standard Deviation | units on a scale | During Cycle 4, 8 of treatment (Up to 32 weeks) |
| ||||||||||||||||||||||||||||||
| Secondary | Rituximab Administration Satisfaction Questionnaire (RASQ) Score | The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. | ITT population included all participants who were randomized in the study. Here, "Number Analyzed" represents the number of participants who were evaluable at specified time points. | Posted | Mean | Standard Deviation | units on a scale | During Cycle 4, 8 of treatment (Up to 32 weeks) |
| ||||||||||||||||||||||||||||||
| Secondary | Complete Response (CR) Rate | CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study. | ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | 28 days (± 3 days) after Day 1 of the last dose of induction treatment |
| ||||||||||||||||||||||||||||||
| Secondary | Event-free Survival (EFS) | EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (<=) 1.0 × <= 1.0 cm would not be considered as abnormal for PD. | ITT population included all participants who were randomized in the study. | Posted | Median | 95% Confidence Interval | months | From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years) |
| ||||||||||||||||||||||||||||||
| Secondary | Disease-free Survival (DFS) | DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first. | ITT population included all participants who were randomized in the study. | Posted | Median | 95% Confidence Interval | months | From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years) |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes <= 1.0 × <= 1.0 cm would not be considered as abnormal for PD. | ITT population included all participants who were randomized in the study. | Posted | Median | 95% Confidence Interval | months | From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years) |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from randomization to death from any cause. | ITT population included all participants who were randomized in the study. | Posted | Median | 95% Confidence Interval | months | From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Rituximab Antibodies Over Time | The safety population included all participants who received at least one dose of rituximab. Here, "Number Analyzed" represents the number of participants who were evaluable at specified time points. | Posted | Number | percentage of participants | Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years) |
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time | The safety population included all participants who received at least one dose of rituximab. Here, "Number Analyzed" represents the number of participants who were evaluable at specified time points. | Posted | Number | percentage of participants | Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years) |
| ||||||||||||||||||||||||||||||||
| Secondary | Summary of Observed Serum Rituximab Concentration | The safety population included all participants who received at least one dose of rituximab. Here, "Number Analyzed" represents the number of participants who were evaluable at specified time points. | Posted | Mean | Standard Deviation | microgram per milliter | Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years) |
|
Randomization of first participant to clinical cutoff date (Up to 4 years)
Not provided
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 | Arm A | Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. | 126 | 371 | 318 | 371 | ||
| EG001 | Arm B | Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. | 116 | 369 | 317 | 369 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumocystis Jirovecii Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchopulmonary Aspergillosis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis Bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Injection site abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Lymph node abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Peritonsillitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pyoderma | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ileal perforation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypertensive encephalopathy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vith nerve paralysis | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypernataemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diabetes insipidus | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Renal cell cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Genital infection bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Systemic infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.1 | 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 |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| 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 |
|---|---|
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| D011239 | Prednisolone |
| D000069461 | Bendamustine Hydrochloride |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| 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 |
| D011246 | Pregnadienetriols |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001562 | Benzimidazoles |
| 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
| Male |
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| Units | Counts |
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| Participants |
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| OG001 | Arm B | Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. |
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| OG001 | Arm B | Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. |
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| OG001 | Arm B | Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. |
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