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Incidence and Prophylactic Administration of Febrile Neutropenia among Untreated Diffuse Large B-Cell Lymphoma Patients Including Those Over 80 Years of Age: a descriptive study using a Japanese administrative database.

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Diffuse Large B-Cell Lymphoma
Date of first enrollment	2024/03/15
Target sample size	1000
Countries of recruitment	Japan
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome

During the 1st Pola-R-CHP therapy where untreated DLBCL patients are treated (for 6 cycles at most) followed by a 90-day safety assessment period, the following will be assessed for the overall population as well as by age group: - the incidence of adverse events related to bone marrow suppression (FN), G-CSF prophylactic administration, and the proportion or cumulative incidence of interventions (such as transfusions for anemia and thrombocytopenia), - calculation of the trend in the proportion of dose reductions of the medication (cyclophosphamide, polatuzumab vedotin, doxorubicin hydrochloride), - and estimation of the distributions of the number of days and frequency of hospitalization.

Secondary Outcome

First, in the R-CHOP group, the same items as in the Pola-R-CHP group will be evaluated. Next, for untreated DLBCL patients receiving 1st line Pola-R-CHP or R-CHOP treatment (up to 6 cycles) + a maximum follow-up period of 90 days, the following will be conducted for both the overall population and by age group: - estimation of the incidence of constipation, diarrhea, and PN requiring treatment, - and calculation of the frequency of the number and types of medications used in the treatment of constipation and PN. Furthermore, in each group or in the combined population, the following will be evaluated: - the temporal trend in the incidence of FN, - the proportion of days of prophylactic administration of G-CSF, - the distribution of days of primary prophylactic administration of G-CSF in the first cycle, - and the incidence of FN by age group and prophylaxis with G-CSF.

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	The earliest day of prescription for R-CHOP or Pola-R-CHP is not included in the patient enrollment period. No tests such as CD20 are performed prior to 60 days of the index date. Index date: the first prescription day of the 1st line 1st cycle.