Study type

Study topic

Disease /health condition

Study type

Non-interventional study

Scope of the study

Disease epidemiology

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Cohort
Case-control
Study drug and medical condition

Medical condition to be studied

Thrombocytopenia
Population studied

Short description of the study population

All adults (≥18 years) with two or more ITP diagnoses registered at least 6 months apart from 1 January 1996 to 31 December 2017.

Exclusion criteria:
o A diagnosis consistent with secondary ITP within 5 years before the date of cITP
o No recorded platelet count below 150×109/L according to the medical record
o A secondary cause of thrombocytopenia stated in the medical record.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Immune thrombocytopenia Patients

Estimated number of subjects

500
Study design details

Main study objective

The objective of the study is to characterize patients with chronic immune thrombocytopenia who have had bone marrow biopsies.

Outcomes

Incidence and prevalence of bone marrow biopsy among patients with chronic immune thrombocytopenia. Characteristics of patients with chronic immune thrombocytopenia who have had a bone marrow biopsy, and outcomes for patients with immune thrombocytopenia who have had a bone marrow biopsy.

Data analysis plan

Statistical analyses will be descriptive (incidence and prevalence) and exploratory (risk factors associated with biopsies as well as outcomes associated with bone marrow biopsies). The latter include hazard ratios for various outcomes.
Documents
Study results

20190429 ORSR_Redacted

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