Observational study of blinatumomab
Study Details
An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices.
Protocol Summary
Proportion of patients with specified AEs as mentioned in description
Timeframe: Estimated to be 100 days
Time to onset of first specified AEs
Timeframe: Estimated to be 100 days
Summary of duration of specified AEs as detailed in the description (all events and resolved/recovered events)
Timeframe: Estimated to be 100 days
Proportion of Blincyto administrations with medication errors
Timeframe: Estimated to be 100 days
Proportion of patients with AEs as detailed in the description
Timeframe: Estimated to be 100 days
Proportion of patients achieving Complete Remission overall and amongst patient sub-groups
Timeframe: Estimated to be 100 days
Proportion of patients achieving CR/CRh*/CRi amongst patient sub-groups
Timeframe: Estimated to be 100 days
Proportion of patients receiving allogeneic HSCT amongst patient sub-groups
Timeframe: Estimated to be 100 days
1-year and 100-day mortality proportion after allogeneic HSCT amongst patient sub-groups
Timeframe: Estimated to be 100 days
Relapse-free survival (RFS) time amongst patient sub-groups
Timeframe: Estimated to be 100 days
Disease Free Survival (DFS) time
Timeframe: Estimated to be 100 days
Overall survival (OS) time amongst patient sub-groups
Timeframe: Estimated to be 100 days
Proportion of patients with MRD achieving CR/CRh*/CRi within 2 cycles of Blincyto
Timeframe: Estimated to be 100 days
Blincyto utilisation: Number of completed cycles
Timeframe: Estimated to be 100 days
Blincyto utilisation: Total number of days of administration
Timeframe: Estimated to be 100 days
Blincyto utilisation: Proportion of patients with dose step-up on Day 8
Timeframe: Day 8
Blincyto utilisation: Number of cycles initiated
Timeframe: Estimated to be 100 days
Blincyto utilisation: Number of bag changes
Timeframe: Estimated to be 100 days
Blincyto utilisation: Proportion of patients with treatment changes
Timeframe: Estimated to be 100 days
Select healthcare resource use: Number of bag changes in each setting
Timeframe: Estimated to be 100 days
Select healthcare resource use: Total number of days of inpatient Blincyto treatment
Timeframe: Estimated to be 100 days
Select healthcare resource use: Proportion of treatment days that were inpatient
Timeframe: Estimated to be 100 days
Select healthcare resource use: Incidence of hospitalization not related to infusion
Timeframe: Estimated to be 100 days
Select healthcare resource use: Length of hospital stay not related to infusion
Timeframe: Estimated to be 100 days