RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] Post-marketing Database Study

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

Study Overview

• Status: Completed
• Conditions: Lymphoma
• Intervention / Treatment: Drug: Rituximab Pfizer; Drug: Rituxan

• Study Type: Observational
• Enrollment (Actual): 2703

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Have prescription of Rituximab Pfizer or Rituxan within the enrollment period (Index Date: first prescription date within the enrollment period).
2. Have diagnosis of CD20 positive B-cell non- Hodgkin's lymphoma on the index month or within 6 months before index date
3. Have at least 6 months of Look back period and at least one medical record prior to 7 months before the Index date.
4. Have not prescription of Rituximab product before index date(Comparative Analysis Set only).

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 .

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposed group; patients treated with Rituximab Pfizer	Drug: Rituximab Pfizer; 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
Comparative group; patients treated with Rituxan	Drug: Rituxan; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2025
• Primary Completion (Actual): March 14, 2025
• Study Completion (Actual): March 14, 2025

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 24, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Infection; Lymphoma; Rituximab
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemic and Lymphatic Diseases; Lymphoma; Infections; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived; Rituximab
• Other Study ID Numbers: B3281009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No