N/A
Completed N=2,703
RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] Post-marketing Database Study
Source: ClinicalTrials.gov NCT06790420 ↗Enrolled (actual)
2,703
Serious AEs
—
Results posted
May 2026
Primary outcomePrimary: Incidence of Infections Which Requires Procedures, Medication or Hospitalization — 0.16; 0.27; 0.16; 0.26 events of infection per person-year
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
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 | — |
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. Informational only — not medical advice.