Trial Outcomes & Findings for RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] Post-marketing Database Study (NCT NCT06790420)
NCT ID: NCT06790420
Last Updated: 2026-05-15
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
2703 participants
Primary outcome timeframe
From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)
Results posted on
2026-05-15
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1301
|
1402
|
|
Overall Study
COMPLETED
|
1301
|
1402
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer]
n=1301 Participants
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.
|
Rituxan
n=1402 Participants
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.
|
Total
n=2703 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 years (Infection)
|
1 participants
n=1271 Participants • 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.
|
3 participants
n=1378 Participants • 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.
|
4 participants
n=2649 Participants • 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.
|
|
Age, Customized
≥18 and <65 years (Infection)
|
222 participants
n=1271 Participants • 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.
|
251 participants
n=1378 Participants • 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.
|
473 participants
n=2649 Participants • 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.
|
|
Age, Customized
≥65 years (Infection)
|
1048 participants
n=1271 Participants • 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.
|
1124 participants
n=1378 Participants • 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.
|
2172 participants
n=2649 Participants • 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.
|
|
Age, Customized
<18 years (Cytopenias)
|
1 participants
n=1179 Participants • 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.
|
2 participants
n=1284 Participants • 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.
|
3 participants
n=2463 Participants • 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.
|
|
Age, Customized
≥18 and <65 years (Cytopenias)
|
202 participants
n=1179 Participants • 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.
|
236 participants
n=1284 Participants • 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.
|
438 participants
n=2463 Participants • 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.
|
|
Age, Customized
≥65 years (Cytopenias)
|
976 participants
n=1179 Participants • 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.
|
1046 participants
n=1284 Participants • 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.
|
2022 participants
n=2463 Participants • 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.
|
|
Age, Customized
<18 years (Infusion reactions)
|
1 participants
n=1301 Participants • 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.
|
3 participants
n=1402 Participants • 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.
|
4 participants
n=2703 Participants • 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.
|
|
Age, Customized
≥18 and <65 years (Infusion reactions)
|
228 participants
n=1301 Participants • 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.
|
256 participants
n=1402 Participants • 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.
|
484 participants
n=2703 Participants • 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.
|
|
Age, Customized
≥65 years (Infusion reactions)
|
1072 participants
n=1301 Participants • 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.
|
1143 participants
n=1402 Participants • 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.
|
2215 participants
n=2703 Participants • 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.
|
|
Age, Customized
<18 years (HFD, Jaundice)
|
1 participants
n=1289 Participants • 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.
|
3 participants
n=1389 Participants • 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.
|
4 participants
n=2678 Participants • 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.
|
|
Age, Customized
≥18 and <65 years (HFD, Jaundice)
|
226 participants
n=1289 Participants • 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.
|
251 participants
n=1389 Participants • 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.
|
477 participants
n=2678 Participants • 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.
|
|
Age, Customized
≥65 years (HFD, Jaundice)
|
1062 participants
n=1289 Participants • 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.
|
1135 participants
n=1389 Participants • 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.
|
2197 participants
n=2678 Participants • 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.
|
|
Age, Customized
<18 years (Cardiac disorder)
|
1 participants
n=1240 Participants • 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.
|
3 participants
n=1346 Participants • 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.
|
4 participants
n=2586 Participants • 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.
|
|
Age, Customized
≥18 and <65 years (Cardiac disorder)
|
220 participants
n=1240 Participants • 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.
|
249 participants
n=1346 Participants • 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.
|
469 participants
n=2586 Participants • 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.
|
|
Age, Customized
≥65 years (Cardiac disorder)
|
1019 participants
n=1240 Participants • 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.
|
1094 participants
n=1346 Participants • 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.
|
2113 participants
n=2586 Participants • 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.
|
|
Age, Customized
<18 years (GI perforation/obstruction)
|
1 participants
n=1288 Participants • 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.
|
3 participants
n=1387 Participants • 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.
|
4 participants
n=2675 Participants • 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.
|
|
Age, Customized
≥18 and <65 years (GI perforation/obstruction)
|
226 participants
n=1288 Participants • 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.
|
253 participants
n=1387 Participants • 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.
|
479 participants
n=2675 Participants • 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.
|
|
Age, Customized
≥65 years (GI perforation/obstruction)
|
1061 participants
n=1288 Participants • 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.
|
1131 participants
n=1387 Participants • 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.
|
2192 participants
n=2675 Participants • 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.
|
|
Age, Customized
<18 years (Hypotension)
|
1 participants
n=1301 Participants • 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.
|
3 participants
n=1402 Participants • 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.
|
4 participants
n=2703 Participants • 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.
|
|
Age, Customized
≥18 and <65 years (Hypotension)
|
228 participants
n=1301 Participants • 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.
|
256 participants
n=1402 Participants • 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.
|
484 participants
n=2703 Participants • 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.
|
|
Age, Customized
≥65 years (Hypotension)
|
1072 participants
n=1301 Participants • 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.
|
1143 participants
n=1402 Participants • 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.
|
2215 participants
n=2703 Participants • 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.
|
|
Age, Customized
<18 years (Development of malignant tumor)
|
1 participants
n=820 Participants • 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.
|
2 participants
n=893 Participants • 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.
|
3 participants
n=1713 Participants • 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.
|
|
Age, Customized
≥18 and <65 years (Development of malignant tumor)
|
153 participants
n=820 Participants • 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.
|
164 participants
n=893 Participants • 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.
|
317 participants
n=1713 Participants • 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.
|
|
Age, Customized
≥65 years (Development of malignant tumor)
|
666 participants
n=820 Participants • 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.
|
727 participants
n=893 Participants • 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.
|
1393 participants
n=1713 Participants • 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.
|
|
Sex: Female, Male
Infection · Female
|
585 Participants
n=1271 Participants • 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.
|
642 Participants
n=1378 Participants • 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.
|
1227 Participants
n=2649 Participants • 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.
|
|
Sex: Female, Male
Infection · Male
|
686 Participants
n=1271 Participants • 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.
|
736 Participants
n=1378 Participants • 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.
|
1422 Participants
n=2649 Participants • 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.
|
|
Sex: Female, Male
Cytopenias · Female
|
548 Participants
n=1179 Participants • 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.
|
594 Participants
n=1284 Participants • 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.
|
1142 Participants
n=2463 Participants • 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.
|
|
Sex: Female, Male
Cytopenias · Male
|
631 Participants
n=1179 Participants • 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.
|
690 Participants
n=1284 Participants • 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.
|
1321 Participants
n=2463 Participants • 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.
|
|
Sex: Female, Male
Infusion reactions · Female
|
600 Participants
n=1301 Participants • 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.
|
652 Participants
n=1402 Participants • 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.
|
1252 Participants
n=2703 Participants • 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.
|
|
Sex: Female, Male
Infusion reactions · Male
|
701 Participants
n=1301 Participants • 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.
|
750 Participants
n=1402 Participants • 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.
|
1451 Participants
n=2703 Participants • 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.
|
|
Sex: Female, Male
HFD, Jaundice · Female
|
594 Participants
n=1289 Participants • 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.
|
647 Participants
n=1389 Participants • 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.
|
1241 Participants
n=2678 Participants • 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.
|
|
Sex: Female, Male
HFD, Jaundice · Male
|
695 Participants
n=1289 Participants • 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.
|
742 Participants
n=1389 Participants • 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.
|
1437 Participants
n=2678 Participants • 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.
|
|
Sex: Female, Male
Cardiac disorder · Female
|
578 Participants
n=1240 Participants • 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.
|
624 Participants
n=1346 Participants • 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.
|
1202 Participants
n=2586 Participants • 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.
|
|
Sex: Female, Male
Cardiac disorder · Male
|
662 Participants
n=1240 Participants • 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.
|
722 Participants
n=1346 Participants • 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.
|
1384 Participants
n=2586 Participants • 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.
|
|
Sex: Female, Male
GI perforation/obstruction · Female
|
595 Participants
n=1288 Participants • 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.
|
645 Participants
n=1387 Participants • 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.
|
1240 Participants
n=2675 Participants • 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.
|
|
Sex: Female, Male
GI perforation/obstruction · Male
|
693 Participants
n=1288 Participants • 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.
|
742 Participants
n=1387 Participants • 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.
|
1435 Participants
n=2675 Participants • 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.
|
|
Sex: Female, Male
Hypotension · Female
|
600 Participants
n=1301 Participants • 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.
|
652 Participants
n=1402 Participants • 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.
|
1252 Participants
n=2703 Participants • 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.
|
|
Sex: Female, Male
Hypotension · Male
|
701 Participants
n=1301 Participants • 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.
|
750 Participants
n=1402 Participants • 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.
|
1451 Participants
n=2703 Participants • 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.
|
|
Sex: Female, Male
Development of malignant tumor · Female
|
414 Participants
n=820 Participants • 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.
|
448 Participants
n=893 Participants • 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.
|
862 Participants
n=1713 Participants • 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.
|
|
Sex: Female, Male
Development of malignant tumor · Male
|
406 Participants
n=820 Participants • 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.
|
445 Participants
n=893 Participants • 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.
|
851 Participants
n=1713 Participants • 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.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)Population: 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.
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.
Outcome measures
| Measure |
RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer]
n=1271 Participants
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.
|
Rituxan
n=1378 Participants
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.
|
|---|---|---|
|
Incidence of Infections Which Requires Procedures, Medication or Hospitalization
Incidence rate of infection (Comparative analysis set, IPTW weighted)
|
0.16 events of infection per person-year
|
0.27 events of infection per person-year
|
|
Incidence of Infections Which Requires Procedures, Medication or Hospitalization
Incidence rate of infection (Comparative analysis set, Propensity score matched)
|
0.16 events of infection per person-year
|
0.26 events of infection per person-year
|
SECONDARY outcome
Timeframe: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)Population: 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.
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.
Outcome measures
| Measure |
RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer]
n=1179 Participants
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.
|
Rituxan
n=1284 Participants
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.
|
|---|---|---|
|
Incidence of 'Pancytopenia, Leukocytopenia, Neutropenia, Agranulocytosis, Thrombocytopenia' (Cytopenias)
Incidence rate of cytopenias (Comparative analysis set, IPTW weighted)
|
1.52 events of cytopenias per person-year
|
1.47 events of cytopenias per person-year
|
|
Incidence of 'Pancytopenia, Leukocytopenia, Neutropenia, Agranulocytosis, Thrombocytopenia' (Cytopenias)
Incidence rate of cytopenias (Comparative analysis set, Propensity score matched)
|
1.57 events of cytopenias per person-year
|
1.44 events of cytopenias per person-year
|
SECONDARY outcome
Timeframe: From index date up to next day after last dose, with a maximum of 5 years (the end of the study period)Population: 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.
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.
Outcome measures
| Measure |
RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer]
n=1301 Participants
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.
|
Rituxan
n=1402 Participants
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.
|
|---|---|---|
|
Incidence of Infusion Reactions
Incidence rate of Infusion reactions (Comparative analysis set, IPTW weighted)
|
1.34 Infusion reaction events per person-year
|
1.44 Infusion reaction events per person-year
|
|
Incidence of Infusion Reactions
Incidence rate of Infusion reactions (Comparative analysis set, Propensity score matched)
|
1.41 Infusion reaction events per person-year
|
1.49 Infusion reaction events per person-year
|
SECONDARY outcome
Timeframe: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)Population: 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.
'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.
Outcome measures
| Measure |
RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer]
n=1289 Participants
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.
|
Rituxan
n=1389 Participants
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.
|
|---|---|---|
|
Incidence of Hepatic Function Disorder (HFD), Jaundice
Incidence rate of HFD, Jaundice (Comparative analysis set, IPTW weighted)
|
0.01 events of HFD, Jaundice per person-year
|
0.01 events of HFD, Jaundice per person-year
|
|
Incidence of Hepatic Function Disorder (HFD), Jaundice
Incidence rate of HFD, Jaundice (Comparative analysis set, Propensity score matched)
|
0.01 events of HFD, Jaundice per person-year
|
0.01 events of HFD, Jaundice per person-year
|
SECONDARY outcome
Timeframe: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)Population: 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.
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.
Outcome measures
| Measure |
RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer]
n=1240 Participants
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.
|
Rituxan
n=1346 Participants
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.
|
|---|---|---|
|
Incidence of Cardiac Disorder
Incidence rate of Cardiac disorder (Comparative analysis set, IPTW weighted)
|
0.20 Cardiac disorder events per person-year
|
0.21 Cardiac disorder events per person-year
|
|
Incidence of Cardiac Disorder
Incidence rate of Cardiac disorder (Comparative analysis set, Propensity score matched)
|
0.23 Cardiac disorder events per person-year
|
0.19 Cardiac disorder events per person-year
|
SECONDARY outcome
Timeframe: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)Population: 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.
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.
Outcome measures
| Measure |
RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer]
n=1288 Participants
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.
|
Rituxan
n=1387 Participants
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.
|
|---|---|---|
|
Incidence of Gastrointestinal (GI) Perforation/Obstruction
Incidence rate of GI perforation/obstruction (Comparative analysis set, IPTW weighted)
|
0.03 GI perf/obst per person-year
|
0.03 GI perf/obst per person-year
|
|
Incidence of Gastrointestinal (GI) Perforation/Obstruction
Incidence rate of GI perforation/obstruction (Comparative analysis set, Propensity score matched)
|
0.02 GI perf/obst per person-year
|
0.03 GI perf/obst per person-year
|
SECONDARY outcome
Timeframe: From index date up to next day after last dose, with a maximum of 5 years (the end of the study period)Population: 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.
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.
Outcome measures
| Measure |
RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer]
n=1301 Participants
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.
|
Rituxan
n=1402 Participants
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.
|
|---|---|---|
|
Incidence of Hypotension
Incidence rate of Hypotension (Comparative analysis set, IPTW weighted)
|
0.13 events of Hypotension per person-year
|
0.04 events of Hypotension per person-year
|
|
Incidence of Hypotension
Incidence rate of Hypotension (Comparative analysis set, Propensity score matched)
|
0.12 events of Hypotension per person-year
|
0.04 events of Hypotension per person-year
|
SECONDARY outcome
Timeframe: From index date up to maximum of 5 years (the end of the study period)Population: 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.
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.
Outcome measures
| Measure |
RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer]
n=820 Participants
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.
|
Rituxan
n=893 Participants
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.
|
|---|---|---|
|
Incidence of Development of Malignant Tumor
Incidence rate of malignant tumor (Comparative analysis set, IPTW weighted)
|
0.09 malignant tumor events per person-year
|
0.08 malignant tumor events per person-year
|
|
Incidence of Development of Malignant Tumor
Incidence rate of malignant tumor (Comparative analysis set, Propensity score matched)
|
0.09 malignant tumor events per person-year
|
0.08 malignant tumor events per person-year
|
Adverse Events
RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rituxan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER