MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma

AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab SC administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.

Time frame: From start of treatment to end of treatment (up to 32 months)

Population: Safety Population included all enrolled participants who received at least one dose of study medication.

DFS was assessed in participants achieving complete response (CR) including complete response unconfirmed (Cru) and was defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus \> 75% decrease in residual lymph node mass, indeterminate bone marrow. Reported here is the truncated mean estimate based on Kaplan-Meier analysis.

Time frame: From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)

Population: ITT population included all enrolled participants.

EFS was defined as the time from first dose of rituximab IV to first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or initiation of a non-protocol-specified anti-lymphoma therapy or death, whichever occurs first. PD: \>/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.

Time frame: From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)

Population: Intent-to-Treat (ITT) population included all enrolled participants.

OS was defined as the time from first dose of rituximab IV to death from any cause.

Time frame: From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)

Population: ITT population included all enrolled participants.

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events. Grading was completed according to the CTCAE, version 4.0.

Time frame: From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)

Population: Safety Population included all enrolled participants who received at least one dose of study medication.

Grading of IIRRs was completed according to the CTCAE, version 4.0.

Time frame: From start of treatment to end of treatment (up to 32 months)

Population: Safety Population included all enrolled participants who received at least one dose of study medication.

SAE was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.

Time frame: From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)

Population: Safety Population included all enrolled participants who received at least one dose of study medication.

PFS was defined as the time from first dose of rituximab IV to the first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or death from any cause. PD: \>/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.

Time frame: From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)

Population: ITT population included all enrolled participants.

Treatment response rate was classified according to the International Working Group (IWG) response criteria: CR/Cru, partial response (PR), stable disease (SD) and PD. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus \> 75% decrease in residual lymph node mass, indeterminate bone marrow; PR: \>/= 50% decrease lymph nodes and nodal mass size; decrease in liver/spleen size, no new sites; SD: less than a PR, but is not PD; PD: \>/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.

Time frame: 4-6 weeks after the last dose of Induction (Up to approximately 8 months)

Population: ITT population included all enrolled participants.