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.

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. - 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.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053834

Enrollment

1000

Registered

2024-04-01

Start date

2024-03-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-Cell Lymphoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients must have a record of DLBCL (Diffuse Large B-Cell Lymphoma) during the patient enrollment period (from September 2022 to September 2023). DLBCL: ICD-10 code C83.3 excluding "8847396 Primary Central Nervous System Diffuse Large B-Cell Lymphoma", or "8847326 Intravascular Large B-Cell Lymphoma" and "8847364 Mediastinal (Thymic) Large B-Cell Lymphoma". All records with a suspicious flag are not used.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactDaisuke Kozuka

Chugai Pharmaceutical Co., Ltd. Safety Science Dept. 2

kozukadis@chugai-pharm.co.jp03-3281-6611

Outcome results