This multi-center, observational, retrospective-prospective cohort study will investigate the safety of rituximab (MabThera) by collecting data from daily clinical practice on the use of rituximab and its relative clinical impact, particularly with regard to adverse events. Data from each patient will be collected over 24 months after enrolment in the study. Target sample size is up to 325 patients.
Study Type
OBSERVATIONAL
Enrollment
209
Percent of patients with at least one grade 3 or 4 adverse event since starting RTX treatment and in the 24 months after study enrollment
Time frame: Up to 31 months (24 months each patient)
Percent of patients with at least one severe adverse event (SAE)
Time frame: Up to 31 months (24 months each patient)
Percent of patients who discontinued therapy with RTX
Time frame: Up to 31 months (24 months each patient)
Time to "re-treatment" with RTX
Time frame: Up to 31 months (24 months each patient)
Features of responders to RTX therapy in terms of co-morbidity and concomitant drugs
Time frame: Up to 31 months (24 months each patient)
Time to response and duration of response to RTX
Time frame: Up to 31 months (24 months each patient)
Percent of patients who achieve remission and relative quality of life (QoL) at 6, 12 and 24 months versus baseline
Time frame: Up to 31 months (24 months each patient)
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Pescara, Abruzzo, Italy
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Brindisi, Apulia, Italy
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Martina Franca, Apulia, Italy
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San Cesario di Lecce, Apulia, Italy
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San Daniele Del Friuli, Apulia, Italy
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Mormanno, Calabria, Italy
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Naples, Campania, Italy
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Naples, Campania, Italy
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Scafati, Campania, Italy
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Bologna, Emilia-Romagna, Italy
...and 44 more locations