Risk factors for serious complications associated with the treatment of immune-mediated diseases using a Japanese large-scale database: A large multi-center exploratory study

Risk factors for serious complications associated with the treatment of immune-mediated diseases using a Japanese large-scale database: A large multi-center exploratory study - Risk factors for serious complications associated with the treatment of immune-mediated diseases using a Japanese large-scale database: A large multi-center exploratory study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050162

Enrollment

200000

Registered

2023-01-30

Start date

2022-09-26

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

Immune-mediated diseases

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: We extracted the database records of patients in the database who were diagnosed with immune-mediated diseases between January 2012 and September 2022.

Exclusion criteria

Exclusion criteria: Patients were excluded from the study if they were diagnosed with malignant disease, MACE, serious infection, or venous or pulmonary thrombosis between April 1, 2008 and December 31, 2011.

Design outcomes

Primary

Measure	Time frame
Prevalence of malignant disease per 100,000 persons; incidence of malignant disease per 100,000 persons; prevalence of MACE per 100,000 persons; incidence of MACE per 100,000 persons; prevalence of serious infections per 100,000 persons; incidence of serious infections per 100,000 persons; prevalence of venous and pulmonary thrombosis per 100,000 persons; incidence of venous and pulmonary thrombosis per 100,000 persons	—

Measure

Time frame

Prevalence of malignant disease per 100,000 persons; incidence of malignant disease per 100,000 persons; prevalence of MACE per 100,000 persons; incidence of MACE per 100,000 persons; prevalence of serious infections per 100,000 persons; incidence of serious infections per 100,000 persons; prevalence of venous and pulmonary thrombosis per 100,000 persons; incidence of venous and pulmonary thrombosis per 100,000 persons

—

Secondary

Measure	Time frame
Hazard ratio for malignant disease; hazard ratio for MACE, hazard ratio for severe infection; hazard ratio for venous and pulmonary thrombosis	—

Countries

Japan

Contacts

Public ContactMasnori Ochi

Faculty of Medicine, University of Tsukuba, Hitachi Medical Education and Research Center Department of Gastroenterology

masaochiphi@md.tsukuba.ac.jp+81-294-23-1111

Outcome results