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To evaluate the incidence of the outcomes for the safety specifications in patients of Medical Data Vision database in Japan diagnosed with CD20 positive B-cell non- Hodgkin's lymphoma who were treated with Rituximab Pfizer to compare it with outcomes in patients who were treated with Rituxan from 01 January 2020 through 31 December 2024
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed group | patients treated with Rituximab Pfizer |
| |
| Comparative group | patients treated with Rituxan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab Pfizer | Drug | For the acute therapy, Rituximab is administrated once a week up to 8 times and for maintenance therapy, it is administrated every 8 weeks up to 12 times |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Infections Which Requires Procedures, Medication or Hospitalization | Infection was expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted. | From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of 'Pancytopenia, Leukocytopenia, Neutropenia, Agranulocytosis, Thrombocytopenia' (Cytopenias) | Cytopenias were expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted. |
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Inclusion Criteria:
Exclusion Criteria:
1. Have any diagnosis of other indications of rituximab products other than CD20 positive B-cell non- Hodgkin's lymphoma before index date .
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The study population includes individuals who have a diagnosis of CD20 positive B-cell non- Hodgkin's lymphoma and treated with Rituximab Pfizer and Rituxan
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Tokyo | Japan |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Data of study patients were extracted from the Medical Data Vision (MDV) database according to the eligibility criteria. The MDV database is a hospital-based claims database in Japan that consists of outpatient and inpatient data from hospitals using the diagnosis procedure combination (DPC) system. The study period was from 01 January 2020 through 31 December 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] | Patients treated with Rituximab Pfizer who were considered eligible by the inclusion/exclusion criteria. The inclusion criteria were as follows: 1. All patients treated with Rituximab Pfizer between 01 January 2020 and 31 December 2024. The first prescription date was set as the index date; 2. Having the defined diagnosis code of CD20 positive B-cell non-Hodgkin's lymphoma on the index month or within 6 months before index month [-6 month to 0 month (index month)]; 3. Having at least one medical record during Look back period (on the index month or within 6 months before index month) and having at least one medical record prior to 7 months before the index month; and 4. Patients without any prior use of Rituximab product before index date. The exclusion criteria were as follows: Having any diagnosis code for following diseases on or before index month: CD20 positive Chronic Lymphocytic Leukemia, Immune thrombocytopenia, Idiopathic Thrombocytopenic Purpura, Nephrotic Syndrome, Granulomatosis with polyangiitis/Microscopic polyangiitis, Acquired Thrombotic Thrombocytopenic Purpura, Systemic Sclerosis, Refractory Pemphigus Vulgaris and Pemphigus Foliaceus, Neuromyelitis Optica Spectrum Disorder, Liver and Kidney transplantation. |
| FG001 | Rituxan | Patients treated with Rituxan who were considered eligible by the inclusion/exclusion criteria. The inclusion criteria were as follows: 1. All patients treated with Rituxan between 01 January 2020 and 31 December 2024. The first prescription date was set as the index date; 2. Having the defined diagnosis code of CD20 positive B-cell non-Hodgkin's lymphoma on the index month or within 6 months before index month [-6 month to 0 month (index month)]; 3. Having at least one medical record during Look back period (on the index month or within 6 months before index month) and having at least one medical record prior to 7 months before the index month; and 4. Patients without any prior use of Rituximab product before index date. The exclusion criteria were as follows: Having any diagnosis code for following diseases on or before index month: CD20 positive Chronic Lymphocytic Leukemia, Immune thrombocytopenia, Idiopathic Thrombocytopenic Purpura, Nephrotic Syndrome, Granulomatosis with polyangiitis/Microscopic polyangiitis, Acquired Thrombotic Thrombocytopenic Purpura, Systemic Sclerosis, Refractory Pemphigus Vulgaris and Pemphigus Foliaceus, Neuromyelitis Optica Spectrum Disorder, Liver and Kidney transplantation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Among the patients extracted from the MDV database, new users who were considered eligible by the inclusion and exclusion criteria (except for the outcome-specific exclusion criteria) were included in the comparative analysis set. For each outcome analysis, the patients who met the outcome-specific exclusion criteria were excluded.
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| ID | Title | Description |
|---|---|---|
| BG000 | RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] | Patients treated with Rituximab Pfizer who were considered eligible by the inclusion/exclusion criteria. The inclusion criteria were as follows: 1. All patients treated with Rituximab Pfizer between 01 January 2020 and 31 December 2024. The first prescription date was set as the index date; 2. Having the defined diagnosis code of CD20 positive B-cell non-Hodgkin's lymphoma on the index month or within 6 months before index month [-6 month to 0 month (index month)]; 3. Having at least one medical record during Look back period (on the index month or within 6 months before index month) and having at least one medical record prior to 7 months before the index month; and 4. Patients without any prior use of Rituximab product before index date. The exclusion criteria were as follows: Having any diagnosis code for following diseases on or before index month: CD20 positive Chronic Lymphocytic Leukemia, Immune thrombocytopenia, Idiopathic Thrombocytopenic Purpura, Nephrotic Syndrome, Granulomatosis with polyangiitis/Microscopic polyangiitis, Acquired Thrombotic Thrombocytopenic Purpura, Systemic Sclerosis, Refractory Pemphigus Vulgaris and Pemphigus Foliaceus, Neuromyelitis Optica Spectrum Disorder, Liver and Kidney transplantation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | For each outcome analysis, the patients who met the outcome-specific exclusion criteria were excluded from the comparative analysis set. The analysis sets were aggregated for each outcome. |
| 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 | Incidence of Infections Which Requires Procedures, Medication or Hospitalization | Infection was expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted. | Among the patients extracted from the MDV database, new users who were considered eligible by the inclusion and exclusion criteria were included in the comparative analysis set. The comparative analysis set (Propensity score matched) was a subset of the comparative analysis set that included all patients matched between Rituximab Pfizer and Rituxan. | Posted | Number | events of infection per person-year | From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period) |
Not applicable as adverse events were not planned to be collected during the study.
Minimum criteria for reporting an adverse event (i.e. identifiable patients, identifiable reporter, a suspect product, and event) could not be met. Hence, adverse events were not collected and reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] | Patients treated with Rituximab Pfizer who were considered eligible by the inclusion/exclusion criteria. The inclusion criteria were as follows: 1. All patients treated with Rituximab Pfizer between 01 January 2020 and 31 December 2024. The first prescription date was set as the index date; 2. Having the defined diagnosis code of CD20 positive B-cell non-Hodgkin's lymphoma on the index month or within 6 months before index month [-6 month to 0 month (index month)]; 3. Having at least one medical record during Look back period (on the index month or within 6 months before index month) and having at least one medical record prior to 7 months before the index month; and 4. Patients without any prior use of Rituximab product before index date. The exclusion criteria were as follows: Having any diagnosis code for following diseases on or before index month: CD20 positive Chronic Lymphocytic Leukemia, Immune thrombocytopenia, Idiopathic Thrombocytopenic Purpura, Nephrotic Syndrome, Granulomatosis with polyangiitis/Microscopic polyangiitis, Acquired Thrombotic Thrombocytopenic Purpura, Systemic Sclerosis, Refractory Pemphigus Vulgaris and Pemphigus Foliaceus, Neuromyelitis Optica Spectrum Disorder, Liver and Kidney transplantation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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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 | Nov 14, 2024 | Feb 13, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 28, 2025 | Feb 13, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D007239 | Infections |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
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| Rituxan | Drug | For the acute therapy, Rituximab is administrated once a week up to 8 times and for maintenance therapy, it is administrated every 8 weeks up to 12 times |
|
| From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period) |
| Incidence of Infusion Reactions | Infusion reactions were expected to occur soon after the exposure. An incident event occurring during the period until the next day after the last dose was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of risk window which was until next day after last dose, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. | From index date up to next day after last dose, with a maximum of 5 years (the end of the study period) |
| Incidence of Hepatic Function Disorder (HFD), Jaundice | 'HFD, Jaundice' were expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted. | From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period) |
| Incidence of Cardiac Disorder | Cardiac disorder was expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted. | From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period) |
| Incidence of Gastrointestinal (GI) Perforation/Obstruction | GI perforation/obstruction was expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted. | From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period) |
| Incidence of Hypotension | Hypotension was expected to occur soon after the exposure. An incident event occurring during the period until the next day after the last dose was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of risk window which was until next day after last dose, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. | From index date up to next day after last dose, with a maximum of 5 years (the end of the study period) |
| Incidence of Development of Malignant Tumor | The observation of a latent outcome event like a malignancy required consideration that the 180-day risk window may not be sufficient. This study analyzed malignancy differently compared to the acute outcome events by extending follow-up time until the first incident event, death, end of the study period, or loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database). Additionally, two types of analyses based on propensity score were conducted. | From index date up to maximum of 5 years (the end of the study period) |
| BG001 | Rituxan | Patients treated with Rituxan who were considered eligible by the inclusion/exclusion criteria. The inclusion criteria were as follows: 1. All patients treated with Rituxan between 01 January 2020 and 31 December 2024. The first prescription date was set as the index date; 2. Having the defined diagnosis code of CD20 positive B-cell non-Hodgkin's lymphoma on the index month or within 6 months before index month [-6 month to 0 month (index month)]; 3. Having at least one medical record during Look back period (on the index month or within 6 months before index month) and having at least one medical record prior to 7 months before the index month; and 4. Patients without any prior use of Rituximab product before index date. The exclusion criteria were as follows: Having any diagnosis code for following diseases on or before index month: CD20 positive Chronic Lymphocytic Leukemia, Immune thrombocytopenia, Idiopathic Thrombocytopenic Purpura, Nephrotic Syndrome, Granulomatosis with polyangiitis/Microscopic polyangiitis, Acquired Thrombotic Thrombocytopenic Purpura, Systemic Sclerosis, Refractory Pemphigus Vulgaris and Pemphigus Foliaceus, Neuromyelitis Optica Spectrum Disorder, Liver and Kidney transplantation. |
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex: Female, Male | For each outcome analysis, the patients who met the outcome-specific exclusion criteria were excluded from the comparative analysis set. The analysis sets were aggregated for each outcome. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] | Patients treated with Rituximab Pfizer who were considered eligible by the inclusion/exclusion criteria. The inclusion criteria were as follows: 1. All patients treated with Rituximab Pfizer between 01 January 2020 and 31 December 2024. The first prescription date was set as the index date; 2. Having the defined diagnosis code of CD20 positive B-cell non-Hodgkin's lymphoma on the index month or within 6 months before index month [-6 month to 0 month (index month)]; 3. Having at least one medical record during Look back period (on the index month or within 6 months before index month) and having at least one medical record prior to 7 months before the index month; and 4. Patients without any prior use of Rituximab product before index date. The exclusion criteria were as follows: Having any diagnosis code for following diseases on or before index month: CD20 positive Chronic Lymphocytic Leukemia, Immune thrombocytopenia, Idiopathic Thrombocytopenic Purpura, Nephrotic Syndrome, Granulomatosis with polyangiitis/Microscopic polyangiitis, Acquired Thrombotic Thrombocytopenic Purpura, Systemic Sclerosis, Refractory Pemphigus Vulgaris and Pemphigus Foliaceus, Neuromyelitis Optica Spectrum Disorder, Liver and Kidney transplantation. |
| OG001 | Rituxan | Patients treated with Rituxan who were considered eligible by the inclusion/exclusion criteria. The inclusion criteria were as follows: 1. All patients treated with Rituxan between 01 January 2020 and 31 December 2024. The first prescription date was set as the index date; 2. Having the defined diagnosis code of CD20 positive B-cell non-Hodgkin's lymphoma on the index month or within 6 months before index month [-6 month to 0 month (index month)]; 3. Having at least one medical record during Look back period (on the index month or within 6 months before index month) and having at least one medical record prior to 7 months before the index month; and 4. Patients without any prior use of Rituximab product before index date. The exclusion criteria were as follows: Having any diagnosis code for following diseases on or before index month: CD20 positive Chronic Lymphocytic Leukemia, Immune thrombocytopenia, Idiopathic Thrombocytopenic Purpura, Nephrotic Syndrome, Granulomatosis with polyangiitis/Microscopic polyangiitis, Acquired Thrombotic Thrombocytopenic Purpura, Systemic Sclerosis, Refractory Pemphigus Vulgaris and Pemphigus Foliaceus, Neuromyelitis Optica Spectrum Disorder, Liver and Kidney transplantation. |
|
|
|
| Secondary | Incidence of 'Pancytopenia, Leukocytopenia, Neutropenia, Agranulocytosis, Thrombocytopenia' (Cytopenias) | Cytopenias were expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted. | Among the patients extracted from the MDV database, new users who were considered eligible by the inclusion and exclusion criteria were included in the comparative analysis set. The comparative analysis set (Propensity score matched) was a subset of the comparative analysis set that included all patients matched between Rituximab Pfizer and Rituxan. | Posted | Number | events of cytopenias per person-year | From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period) |
|
|
|
|
| Secondary | Incidence of Infusion Reactions | Infusion reactions were expected to occur soon after the exposure. An incident event occurring during the period until the next day after the last dose was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of risk window which was until next day after last dose, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. | Among the patients extracted from the MDV database, new users who were considered eligible by the inclusion and exclusion criteria were included in the comparative analysis set. The comparative analysis set (Propensity score matched) was a subset of the comparative analysis set that included all patients matched between Rituximab Pfizer and Rituxan. | Posted | Number | Infusion reaction events per person-year | From index date up to next day after last dose, with a maximum of 5 years (the end of the study period) |
|
|
|
|
| Secondary | Incidence of Hepatic Function Disorder (HFD), Jaundice | 'HFD, Jaundice' were expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted. | Among the patients extracted from the MDV database, new users who were considered eligible by the inclusion and exclusion criteria were included in the comparative analysis set. The comparative analysis set (Propensity score matched) was a subset of the comparative analysis set that included all patients matched between Rituximab Pfizer and Rituxan. | Posted | Number | events of HFD, Jaundice per person-year | From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period) |
|
|
|
|
| Secondary | Incidence of Cardiac Disorder | Cardiac disorder was expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted. | Among the patients extracted from the MDV database, new users who were considered eligible by the inclusion and exclusion criteria were included in the comparative analysis set. The comparative analysis set (Propensity score matched) was a subset of the comparative analysis set that included all patients matched between Rituximab Pfizer and Rituxan. | Posted | Number | Cardiac disorder events per person-year | From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period) |
|
|
|
|
| Secondary | Incidence of Gastrointestinal (GI) Perforation/Obstruction | GI perforation/obstruction was expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted. | Among the patients extracted from the MDV database, new users who were considered eligible by the inclusion and exclusion criteria were included in the comparative analysis set. The comparative analysis set (Propensity score matched) was a subset of the comparative analysis set that included all patients matched between Rituximab Pfizer and Rituxan. | Posted | Number | GI perf/obst per person-year | From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period) |
|
|
|
|
| Secondary | Incidence of Hypotension | Hypotension was expected to occur soon after the exposure. An incident event occurring during the period until the next day after the last dose was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of risk window which was until next day after last dose, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. | Among the patients extracted from the MDV database, new users who were considered eligible by the inclusion and exclusion criteria were included in the comparative analysis set. The comparative analysis set (Propensity score matched) was a subset of the comparative analysis set that included all patients matched between Rituximab Pfizer and Rituxan. | Posted | Number | events of Hypotension per person-year | From index date up to next day after last dose, with a maximum of 5 years (the end of the study period) |
|
|
|
|
| Secondary | Incidence of Development of Malignant Tumor | The observation of a latent outcome event like a malignancy required consideration that the 180-day risk window may not be sufficient. This study analyzed malignancy differently compared to the acute outcome events by extending follow-up time until the first incident event, death, end of the study period, or loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database). Additionally, two types of analyses based on propensity score were conducted. | Among the patients extracted from the MDV database, new users who were considered eligible by the inclusion and exclusion criteria were included in the comparative analysis set. The comparative analysis set (Propensity score matched) was a subset of the comparative analysis set that included all patients matched between Rituximab Pfizer and Rituxan. | Posted | Number | malignant tumor events per person-year | From index date up to maximum of 5 years (the end of the study period) |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Rituxan | Patients treated with Rituxan who were considered eligible by the inclusion/exclusion criteria. The inclusion criteria were as follows: 1. All patients treated with Rituxan between 01 January 2020 and 31 December 2024. The first prescription date was set as the index date; 2. Having the defined diagnosis code of CD20 positive B-cell non-Hodgkin's lymphoma on the index month or within 6 months before index month [-6 month to 0 month (index month)]; 3. Having at least one medical record during Look back period (on the index month or within 6 months before index month) and having at least one medical record prior to 7 months before the index month; and 4. Patients without any prior use of Rituximab product before index date. The exclusion criteria were as follows: Having any diagnosis code for following diseases on or before index month: CD20 positive Chronic Lymphocytic Leukemia, Immune thrombocytopenia, Idiopathic Thrombocytopenic Purpura, Nephrotic Syndrome, Granulomatosis with polyangiitis/Microscopic polyangiitis, Acquired Thrombotic Thrombocytopenic Purpura, Systemic Sclerosis, Refractory Pemphigus Vulgaris and Pemphigus Foliaceus, Neuromyelitis Optica Spectrum Disorder, Liver and Kidney transplantation. | 0 | 0 | 0 | 0 | 0 | 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Male |
|
| Male |
|
| Male |
|
| Male |
|
| Male |
|
| Male |
|
| Male |
|
| Incidence rate of cytopenias (Comparative analysis set, Propensity score matched) |
|
|
Comparative analysis set, IPTW weighted |
| Incidence rate ratio |
| 1.032 |
| 2-Sided |
| 95 |
| 0.792 |
| 1.344 |
Incidence rate ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. |
| Other |
Estimation |
| Comparative analysis set, IPTW weighted | Hazard Ratio (HR) | 1.069 | 2-Sided | 95 | 0.939 | 1.217 | Hazard Ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Incidence rate difference | 0.135 | 2-Sided | 95 | -0.331 | 0.578 | Incidence rate difference (Exposed - Reference), where the Exposed group is Rituximab Pfizer and the Reference group is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Incidence rate ratio | 1.093 | 2-Sided | 95 | 0.808 | 1.480 | Incidence rate ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Hazard Ratio (HR) | 1.117 | 2-Sided | 95 | 0.975 | 1.280 | Hazard Ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Incidence rate of Infusion reactions (Comparative analysis set, Propensity score matched) |
|
|
Comparative analysis set, IPTW weighted |
| Incidence rate ratio |
| 0.927 |
| 2-Sided |
| 95 |
| 0.698 |
| 1.229 |
Incidence rate ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. |
| Other |
Estimation |
| Comparative analysis set, IPTW weighted | Hazard Ratio (HR) | 0.995 | 2-Sided | 95 | 0.847 | 1.168 | Hazard Ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Incidence rate difference | -0.083 | 2-Sided | 95 | -0.576 | 0.377 | Incidence rate difference (Exposed - Reference), where the Exposed group is Rituximab Pfizer and the Reference group is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Incidence rate ratio | 0.944 | 2-Sided | 95 | 0.682 | 1.307 | Incidence rate ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Hazard Ratio (HR) | 1.029 | 2-Sided | 95 | 0.870 | 1.216 | Hazard Ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Incidence rate of HFD, Jaundice (Comparative analysis set, Propensity score matched) |
|
|
Comparative analysis set, IPTW weighted |
| Incidence rate ratio |
| 0.81 |
| 2-Sided |
| 95 |
| 0.112 |
| 5.855 |
Incidence rate ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. |
| Other |
Estimation |
| Comparative analysis set, IPTW weighted | Hazard Ratio (HR) | 0.842 | 2-Sided | 95 | 0.242 | 2.922 | Hazard Ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Incidence rate difference | -0.001 | 2-Sided | 95 | -0.029 | 0.017 | Incidence rate difference (Exposed - Reference), where the Exposed group is Rituximab Pfizer and the Reference group is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Incidence rate ratio | 0.93 | 2-Sided | 95 | 0.103 | 8.372 | Incidence rate ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Hazard Ratio (HR) | 0.945 | 2-Sided | 95 | 0.240 | 3.714 | Hazard Ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Incidence rate of Cardiac disorder (Comparative analysis set, Propensity score matched) |
|
|
Comparative analysis set, IPTW weighted |
| Incidence rate ratio |
| 0.932 |
| 2-Sided |
| 95 |
| 0.616 |
| 1.409 |
Incidence rate ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. |
| Other |
Estimation |
| Comparative analysis set, IPTW weighted | Hazard Ratio (HR) | 1.001 | 2-Sided | 95 | 0.771 | 1.300 | Hazard Ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Incidence rate difference | 0.043 | 2-Sided | 95 | -0.063 | 0.143 | Incidence rate difference (Exposed - Reference), where the Exposed group is Rituximab Pfizer and the Reference group is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Incidence rate ratio | 1.226 | 2-Sided | 95 | 0.751 | 2.004 | Incidence rate ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Hazard Ratio (HR) | 1.26 | 2-Sided | 95 | 0.949 | 1.673 | Hazard Ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Incidence rate of GI perforation/obstruction (Comparative analysis set, Propensity score matched) |
|
|
Comparative analysis set, IPTW weighted |
| Incidence rate ratio |
| 0.864 |
| 2-Sided |
| 95 |
| 0.316 |
| 2.363 |
Incidence rate ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. |
| Other |
Estimation |
| Comparative analysis set, IPTW weighted | Hazard Ratio (HR) | 0.902 | 2-Sided | 95 | 0.455 | 1.787 | Hazard Ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Incidence rate difference | -0.009 | 2-Sided | 95 | -0.051 | 0.020 | Incidence rate difference (Exposed - Reference), where the Exposed group is Rituximab Pfizer and the Reference group is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Incidence rate ratio | 0.72 | 2-Sided | 95 | 0.223 | 2.325 | Incidence rate ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Hazard Ratio (HR) | 0.767 | 2-Sided | 95 | 0.356 | 1.655 | Hazard Ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Incidence rate of Hypotension (Comparative analysis set, Propensity score matched) |
|
|
Comparative analysis set, IPTW weighted |
| Incidence rate ratio |
| 3.139 |
| 2-Sided |
| 95 |
| 0.989 |
| 9.946 |
Incidence rate ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. |
| Other |
Estimation |
| Comparative analysis set, IPTW weighted | Hazard Ratio (HR) | 3.359 | 2-Sided | 95 | 1.750 | 6.448 | Hazard Ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Incidence rate difference | 0.08 | 2-Sided | 95 | -0.022 | 0.210 | Incidence rate difference (Exposed - Reference), where the Exposed group is Rituximab Pfizer and the Reference group is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Incidence rate ratio | 2.788 | 2-Sided | 95 | 0.756 | 10.272 | Incidence rate ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Hazard Ratio (HR) | 3.044 | 2-Sided | 95 | 1.494 | 6.201 | Hazard Ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Incidence rate of malignant tumor (Comparative analysis set, Propensity score matched) |
|
|
Comparative analysis set, IPTW weighted |
| Incidence rate ratio |
| 1.123 |
| 2-Sided |
| 95 |
| 0.684 |
| 1.845 |
Incidence rate ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. |
| Other |
Estimation |
| Comparative analysis set, IPTW weighted | Hazard Ratio (HR) | 1.129 | 2-Sided | 95 | 0.814 | 1.566 | Hazard Ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Incidence rate difference | 0.011 | 2-Sided | 95 | -0.042 | 0.058 | Incidence rate difference (Exposed - Reference), where the Exposed group is Rituximab Pfizer and the Reference group is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Incidence rate ratio | 1.131 | 2-Sided | 95 | 0.637 | 2.008 | Incidence rate ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |
| Comparative analysis set, Propensity score matched | Hazard Ratio (HR) | 1.107 | 2-Sided | 95 | 0.779 | 1.575 | Hazard Ratio of Exposed/Reference, where Exposed is Rituximab Pfizer and Reference is Rituxan. | Other | Estimation |