The primary objective of this study is to assess the overall safety profile of idelalisib monotherapy in patients with refractory follicular lymphoma (FL).
Study Type
OBSERVATIONAL
Enrollment
257
Tablets administered according to the product information and treatment guidelines in routine clinical practice
Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AE), Serious AEs, Special Situation Reports, Adverse Drug Reactions (ADR), and Serious ADRs
Time frame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)
Overall Response Rate (ORR)
ORR is defined as the proportion of participants who achieve a clinical response with or without radiological confirmation as documented within their electronic health record after the initiation of treatment with idelalisib and during the treatment period with idelalisib.
Time frame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)
Duration of Response (DOR)
DOR is defined as the interval from the first documentation of a clinical response with or without radiological confirmation to the earlier of the first documentation of disease progression or death from any cause.
Time frame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)
Progression-free Survival (PFS)
PFS is defined as the interval from the date of initiation of idelalisib to the earlier date of the first documentation of disease progression or death from any cause.
Time frame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)
Time to Next Treatment (TTNT)
TTNT is defined as the interval from the initiation of treatment with idelalisib to the earlier date of the initiation of next systemic treatment of Follicular Lymphoma (excluding palliative care or palliative radiation) or death from any cause.
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Ziekenhuis Netwerk Antwerpen Stuivenberg Hospital
Antwerp, Belgium
Centre Hospitalier Universitaire d'Amiens (CHU d'Amiens) - Hopital Nord
Amiens, France
Centre Hospitalier Bourg-en-Bresse Fleyriat
Bourg-en-Bresse, France
Centre Hospitalier de Cannes
Cannes, France
Hôpital Privé Sévigné
Cesson-Sévigné, France
Centre Hospitalier Chalon sur Saône William Morey
Chalon-sur-Saône, France
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, France
CHU de Dijon
Dijon, France
Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard
Grenoble, France
Clinique Victor Hugo
Le Mans, France
...and 78 more locations
Time frame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)
Overall Survival (OS)
OS is defined as the interval from the date of initiation of idelalisib to death from any cause.
Time frame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)