Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

BLINATUMOMAB
Population studied

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)
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

Hepatic impaired
Immunocompromised
Pregnant women
Renal impaired

Estimated number of subjects

279
Study design details

Main study objective

The first primary objective is to characterize the safety profile of Blincyto in routine clinical practice in countries in the EU by characterising specific AEs. The second primary objective is to estimate the frequency and type of medication errors identified in patient charts.

Outcomes

Incidence of specified AEs. Time to onset of first specified AEs. Summary of duration of specified AEs. Proportion of Blincyto administrations with medication errors. Incidence of AEs collected. Incidence of specified AEs and AEs collected among patient subgroups. Proportion of patient achieving CR, CR/CRh*/CRi, MRD within 2 cycles of Blincyto. Proportion of patients receiving allogeneic HSCT. 1 year and 100 day mortality proportion after HSCT. Relapse free survival time. Disease free survival. Overall survival. Healthcare resource use. Blinicyto Utilization.

Data analysis plan

All analyses will be descriptive. Continuous variables will be summarised by mean, median, standard deviation, 25th percentile, 75th percentile, minimum and maximum. Categorical variables will be summarised by number and percentage. For categorical outcomes, 95% confidence intervals (CIs) will also be presented where appropriate. For time-to-event endpoints, Kaplan-Meier (KM) curves and estimates (median, 1st and 3rd quartile) of the time-to-event endpoint with 95% confidence intervals will be calculated, if estimable. Six, 12- and 24-month survival proportions and 95% confidence intervals will also be estimated. Subject incidence (and 95% CIs) for adverse events will be summarised and tabulated by system organ class and preferred term. Incidence tables will also be presented with respect to time on Blincyto at the patient level (incidence rate) and event level (event rate).
Documents
Study results
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