N/A
N=2,703
RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] Post-marketing Database Study
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT06790420 ↗Enrolled (actual)
2,703
Serious AEs
—
Results posted
May 2026
Primary outcome: Primary: Incidence of Infections Which Requires Procedures, Medication or Hospitalization — 0.16; 0.27; 0.16; 0.26 events of infection per person-year
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Rituximab Pfizer (Drug); Rituxan (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Infections Which Requires Procedures, Medication or Hospitalization |
0.16; 0.27; 0.16; 0.26 | — |
| SECONDARY Incidence of 'Pancytopenia, Leukocytopenia, Neutropenia, Agranulocytosis, Thrombocytopenia' (Cytopenias) |
1.52; 1.47; 1.57; 1.44 | — |
| SECONDARY Incidence of Infusion Reactions |
1.34; 1.44; 1.41; 1.49 | — |
| SECONDARY Incidence of Hepatic Function Disorder (HFD), Jaundice |
0.01; 0.01; 0.01; 0.01 | — |
| SECONDARY Incidence of Cardiac Disorder |
0.20; 0.21; 0.23; 0.19 | — |
| SECONDARY Incidence of Gastrointestinal (GI) Perforation/Obstruction |
0.03; 0.03; 0.02; 0.03 | — |
| SECONDARY Incidence of Hypotension |
0.13; 0.04; 0.12; 0.04 | — |
| SECONDARY Incidence of Development of Malignant Tumor |
0.09; 0.08; 0.09; 0.08 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- Have prescription of Rituximab Pfizer or Rituxan within the enrollment period (Index Date: first prescription date within the enrollment period).
- Have diagnosis of CD20 positive B-cell non- Hodgkin's lymphoma on the index month or within 6 months before index date
- Have at least 6 months of Look back period and at least one medical record prior to 7 months before the Index date.
- Have not prescription of Rituximab product before index date(Comparative Analysis Set only).
Exclusion Criteria
- Have any diagnosis of other indications of rituximab products other than CD20 positive B-cell non- Hodgkin's lymphoma before index date .
Data sourced from ClinicalTrials.gov (NCT06790420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.