Lymphoma
Conditions
Keywords
Lymphoma, Rituximab, Infection
Brief 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
Interventions
DRUGRituximab 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
DRUGRituxan
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
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Infections Which Requires Procedures, Medication or Hospitalization | From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of 'Pancytopenia, Leukocytopenia, Neutropenia, Agranulocytosis, Thrombocytopenia' (Cytopenias) | From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period) | 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. |
| Incidence of Infusion Reactions | From index date up to next day after last dose, with a maximum of 5 years (the end of the study period) | 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. |
| Incidence of Hepatic Function Disorder (HFD), Jaundice | From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period) | '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. |
| Incidence of Cardiac Disorder | From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period) | 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. |
| Incidence of Gastrointestinal (GI) Perforation/Obstruction | From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period) | 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. |
| Incidence of Hypotension | From index date up to next day after last dose, with a maximum of 5 years (the end of the study period) | 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. |
| Incidence of Development of Malignant Tumor | From index date up to maximum of 5 years (the end of the study period) | 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. |
Countries
Japan
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized ≥18 and <65 years (Cardiac disorder) | 220 participants |
| Age, Customized ≥18 and <65 years (Cytopenias) | 438 participants |
| Age, Customized ≥18 and <65 years (Development of malignant tumor) | 153 participants |
| Age, Customized ≥18 and <65 years (GI perforation/obstruction) | 479 participants |
| Age, Customized ≥18 and <65 years (HFD, Jaundice) | 477 participants |
| Age, Customized ≥18 and <65 years (Hypotension) | 484 participants |
| Age, Customized ≥18 and <65 years (Infection) | 251 participants |
| Age, Customized ≥18 and <65 years (Infusion reactions) | 484 participants |
| Age, Customized <18 years (Cardiac disorder) | 3 participants |
| Age, Customized <18 years (Cytopenias) | 2 participants |
| Age, Customized <18 years (Development of malignant tumor) | 3 participants |
| Age, Customized <18 years (GI perforation/obstruction) | 3 participants |
| Age, Customized <18 years (HFD, Jaundice) | 1 participants |
| Age, Customized <18 years (Hypotension) | 1 participants |
| Age, Customized <18 years (Infection) | 4 participants |
| Age, Customized <18 years (Infusion reactions) | 4 participants |
| Age, Customized ≥65 years (Cardiac disorder) | 2113 participants |
| Age, Customized ≥65 years (Cytopenias) | 976 participants |
| Age, Customized ≥65 years (Development of malignant tumor) | 1393 participants |
| Age, Customized ≥65 years (GI perforation/obstruction) | 1061 participants |
| Age, Customized ≥65 years (HFD, Jaundice) | 1135 participants |
| Age, Customized ≥65 years (Hypotension) | 2215 participants |
| Age, Customized ≥65 years (Infection) | 1048 participants |
| Age, Customized ≥65 years (Infusion reactions) | 1072 participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Cardiac disorder Female | 624 Participants |
| Sex: Female, Male Cardiac disorder Male | 722 Participants |
| Sex: Female, Male Cytopenias Female | 548 Participants |
| Sex: Female, Male Cytopenias Male | 1321 Participants |
| Sex: Female, Male Development of malignant tumor Female | 862 Participants |
| Sex: Female, Male Development of malignant tumor Male | 406 Participants |
| Sex: Female, Male GI perforation/obstruction Female | 1240 Participants |
| Sex: Female, Male GI perforation/obstruction Male | 693 Participants |
| Sex: Female, Male HFD, Jaundice Female | 647 Participants |
| Sex: Female, Male HFD, Jaundice Male | 1437 Participants |
| Sex: Female, Male Hypotension Female | 600 Participants |
| Sex: Female, Male Hypotension Male | 750 Participants |
| Sex: Female, Male Infection Female | 642 Participants |
| Sex: Female, Male Infection Male | 686 Participants |
| Sex: Female, Male Infusion reactions Female | 652 Participants |
| Sex: Female, Male Infusion reactions Male | 750 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed