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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001118-14 | EudraCT Number |
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This open-label, single-arm, phase IIIb study will evaluate the safety of switching from intravenous (IV) to subcutaneous (SC) administration of rituximab during first-line treatment for participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) who have already received at least one full dose of rituximab IV. Participants with FL will be given 1400 mg rituximab SC during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). 1400 mg SC of rituximab will be given to participants with DLBCL once monthly for 4-7 cycles. Treatment duration is expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous Rituximab | Experimental | Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab will be treated with subcutaneous (SC) rituximab. Participants with FL will be administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL will be administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration is expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | 1400 mg will be injected subcutaneously (SC). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Administration-Associated Reactions (AARs) | AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab SC administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. | From start of treatment to end of treatment (up to 32 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With At Least One Grade >/= 3 Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events. Grading was completed according to the CTCAE, version 4.0. |
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Inclusion Criteria:
Induction only:
FL treatment-related criteria
- Currently being treated with rituximab IV during first-line therapy and has received at least one full dose of rituximab IV.
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital De Txagorritxu; Servicio de Hematologia | Vitoria-Gasteiz | Alava | 01009 | Spain | ||
| Hospital General de Elda; Servicio de Hematologia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35126524 | Derived | Petrini M, Gaidano G, Mengarelli A, Consoli U, Santoro A, Liberati AM, Ladetto M, Fraticelli V, Guarini A, Mannina D, Ferrando P, Corradini P, Musto P, Stelitano C, Marino D, Camera A, Murineddu M, Battistini R, Caparrotti G, Turrini M, Arcaini L, Santini S, Cerqueti M, Ferreri AJM, Cantore N, Inzoli A, Cardinale G, Ronci B, La Nasa G, Massimi S, Gaglione G, Barbiero V, Martelli M. Safety and Efficacy of Subcutaneous Rituximab in Previously Untreated Patients with CD20+ Diffuse Large B-Cell Lymphoma or Follicular Lymphoma: Results from an Italian Phase IIIb Study. Adv Hematol. 2022 Jan 27;2022:5581772. doi: 10.1155/2022/5581772. eCollection 2022. | |
| 31573078 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subcutaneous Rituximab | Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2013 | Apr 4, 2018 |
Not provided
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| From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months) |
| Percentage of Participants With At Least One Grade >/= 3 Infusion/ Injection Related Reactions (IIRRs) | Grading of IIRRs was completed according to the CTCAE, version 4.0. | From start of treatment to end of treatment (up to 32 months) |
| Percentage of Participants With At Least One Serious Adverse Event (SAE) | SAE was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. | From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months) |
| Event-Free Survival (EFS) | EFS was defined as the time from first dose of rituximab IV to first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or initiation of a non-protocol-specified anti-lymphoma therapy or death, whichever occurs first. PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities. | From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months) |
| Progression-Free Survival (PFS) | PFS was defined as the time from first dose of rituximab IV to the first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or death from any cause. PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities. | From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months) |
| Overall Survival (OS) | OS was defined as the time from first dose of rituximab IV to death from any cause. | From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months) |
| Disease-Free Survival (DFS) | DFS was assessed in participants achieving complete response (CR) including complete response unconfirmed (Cru) and was defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus > 75% decrease in residual lymph node mass, indeterminate bone marrow. Reported here is the truncated mean estimate based on Kaplan-Meier analysis. | From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months) |
| Treatment Response Rate | Treatment response rate was classified according to the International Working Group (IWG) response criteria: CR/Cru, partial response (PR), stable disease (SD) and PD. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus > 75% decrease in residual lymph node mass, indeterminate bone marrow; PR: >/= 50% decrease lymph nodes and nodal mass size; decrease in liver/spleen size, no new sites; SD: less than a PR, but is not PD; PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities. | 4-6 weeks after the last dose of Induction (Up to approximately 8 months) |
| Elda |
| Alicante |
| 03600 |
| Spain |
| Hospital Son Llatzer; Servicio de Hematologia | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Hospital de Granollers, Servicio de HematologÃa | Granollers | Barcelona | 08400 | Spain |
| Hospital Mutua de Terrassa; Servicio de Hematologia | Terrassa | Barcelona | 08221 | Spain |
| Hospital General de Castellon; Servicio de Hematologia | Castellon | Castellon | 12004 | Spain |
| Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Hematologia | A Coruña | LA Coruña | 15006 | Spain |
| Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Hematologia | Santiago de Compostela | LA Coruña | 15706 | Spain |
| Complejo Hospitalario San Millan - San Pedro; Servicio Hematologia | Logroño | La Rioja | 26006 | Spain |
| Complejo Asistencial de León, Servicio de HematologÃa | León | LEON | 24008 | Spain |
| Hospital Universitario de Fuenlabrada; Servicio de Hematologia | Fuenlabrada | Madrid | 28943 | Spain |
| Hospital Severo Ochoa; Servicio de Hematologia | Leganés | Madrid | 28911 | Spain |
| Hosital Universitario de Mostoles;Servicio de Hematologia | Móstoles | Madrid | 28935 | Spain |
| Clinica Universitaria de Navarra; Servicio de Hematologia | Pamplona | Navarre | 31008 | Spain |
| Hospital de Navarra, Servicio de HematologÃa | Pamplona | Navarre | 31008 | Spain |
| Complejo Hospitalario Universitario de Vigo; Servicio de Hematologia | Vigo | Pontevedra | 36204 | Spain |
| Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia | Santa Cruz de Tenerife | Tenerife | 38010 | Spain |
| Hospital de Basurto; Servicio de Hematologia | Bilbao | Vizcaya | 48013 | Spain |
| Hospital de Galdakano; Servicio de Hematologia | Galdakao | Vizcaya | 48960 | Spain |
| Complejo Hospitalario Torrecardenas; Servicio de Hematologia | AlmerÃa | 04009 | Spain |
| Hospital Universitario de Burgos, Servicio de HematologÃa | Burgos | 09006 | Spain |
| Hospital Universitario Reina Sofia; Servicio de Hematologia | Córdoba | 14004 | Spain |
| Hospital Universitario Virgen de las Nieves; Servicio de Hematologia | Granada | 18014 | Spain |
| Hospital Universitario de Gaudalajara; HematologÃa | Guadalajara | 19002 | Spain |
| Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Hematologia | Lleida | 25198 | Spain |
| Hospital Infanta Leonor; Servicio de Hematologia | Madrid | 28031 | Spain |
| Fundacion Jimenez Diaz; Servicio de Hematologia | Madrid | 28040 | Spain |
| Hospital Universitario ClÃnico San Carlos; Servicio de HematologÃa | Madrid | 28040 | Spain |
| HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia | Madrid | 28050 | Spain |
| Hospital Universitario Puerta de Hierro; Servicio de Hematologia | Madrid | 28222 | Spain |
| Hospital Universitario Principe de Asturias; Servicio de HematologÃa | Madrid | 28805 | Spain |
| Hospital Univ. Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital General Universitario J.M Morales Meseguer; Servicio de HematologÃa | Murcia | 30008 | Spain |
| Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia | Murcia | 30120 | Spain |
| Complejo Hospitalario de Pontevedra; Servicio de Hematologia | Pontevedra | 36071 | Spain |
| Complejo Asistencial de Segovia | Segovia | 40002 | Spain |
| Hospital Universitario Virgen Macarena; Servicio de Hematologia | Seville | 41009 | Spain |
| Hospital Univ. Nuestra Señora de Valme; Servicio de Hematologia | Seville | 41014 | Spain |
| Hospital de Rio Hortega; Servicio de Hematologia | Valladolid | 47010 | Spain |
| Derived |
| Garcia-Munoz R, Quero C, Perez-Persona E, Domingo-Garcia A, Perez-Lopez C, Villaescusa-de-la-Rosa T, Martinez-Castro AM, Arguinano-Perez JM, Parra-Cuadrado JF, Panizo C. Safety of switching from intravenous to subcutaneous rituximab during first-line treatment of patients with non-Hodgkin lymphoma: the Spanish population of the MabRella study. Br J Haematol. 2020 Mar;188(5):661-673. doi: 10.1111/bjh.16227. Epub 2019 Oct 1. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) population included all enrolled participants. All analyses described have been performed by type of lymphoma (DLBCL/ FL) and overall.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Diffuse Large B-Cell Lymphoma | Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL. |
| BG001 | Follicular Lymphoma | Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL. |
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 Administration-Associated Reactions (AARs) | AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab SC administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. | Safety Population included all enrolled participants who received at least one dose of study medication. | Posted | Number | percentage of participants | From start of treatment to end of treatment (up to 32 months) |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With At Least One Grade >/= 3 Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events. Grading was completed according to the CTCAE, version 4.0. | Safety Population included all enrolled participants who received at least one dose of study medication. | Posted | Number | percentage of participants | From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With At Least One Grade >/= 3 Infusion/ Injection Related Reactions (IIRRs) | Grading of IIRRs was completed according to the CTCAE, version 4.0. | Safety Population included all enrolled participants who received at least one dose of study medication. | Posted | Number | percentage of participants | From start of treatment to end of treatment (up to 32 months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With At Least One Serious Adverse Event (SAE) | SAE was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. | Safety Population included all enrolled participants who received at least one dose of study medication. | Posted | Number | percentage of participants | From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Event-Free Survival (EFS) | EFS was defined as the time from first dose of rituximab IV to first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or initiation of a non-protocol-specified anti-lymphoma therapy or death, whichever occurs first. PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities. | Intent-to-Treat (ITT) population included all enrolled participants. | Posted | Mean | 95% Confidence Interval | months | From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | PFS was defined as the time from first dose of rituximab IV to the first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or death from any cause. PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities. | ITT population included all enrolled participants. | Posted | Mean | 95% Confidence Interval | months | From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from first dose of rituximab IV to death from any cause. | ITT population included all enrolled participants. | Posted | Mean | 95% Confidence Interval | months | From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Disease-Free Survival (DFS) | DFS was assessed in participants achieving complete response (CR) including complete response unconfirmed (Cru) and was defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus > 75% decrease in residual lymph node mass, indeterminate bone marrow. Reported here is the truncated mean estimate based on Kaplan-Meier analysis. | ITT population included all enrolled participants. | Posted | Mean | 95% Confidence Interval | months | From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Treatment Response Rate | Treatment response rate was classified according to the International Working Group (IWG) response criteria: CR/Cru, partial response (PR), stable disease (SD) and PD. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus > 75% decrease in residual lymph node mass, indeterminate bone marrow; PR: >/= 50% decrease lymph nodes and nodal mass size; decrease in liver/spleen size, no new sites; SD: less than a PR, but is not PD; PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities. | ITT population included all enrolled participants. | Posted | Number | percentage of participants | 4-6 weeks after the last dose of Induction (Up to approximately 8 months) |
|
From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.
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 | Subcutaneous Rituximab | Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL. | 4 | 140 | 42 | 140 | 117 | 140 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Enterobacter bacteraemia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Gastric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 11, 2017 | Apr 4, 2018 | SAP_001.pdf |
| 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
| Male |
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| Caucasian |
|
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| At Least One Serious AARs |
|
| Generalised or Remote from the Injection Site AARs |
|
| Localised at the injection site AARs |
|
| OG002 | Subcutaneous Rituximab | Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL. |
|
|
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL. |
|
|
| OG002 | Subcutaneous Rituximab | Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL. |
|
|
| OG002 | Subcutaneous Rituximab | Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL. |
|
|
| OG002 | Subcutaneous Rituximab | Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL. |
|
|
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL. |
|
|
| OG002 | Subcutaneous Rituximab | Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL. |
|
|
| OG002 | Subcutaneous Rituximab | Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL. |
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