Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma

The Complete Response Rate (CR/CRu) is the percentage of participants who achieve complete response (CR/CRu) at 120 weeks as assessed per Independent Central Review.

• Complete Response (CR): Disappearance of all evidence of disease.
• Complete Response Unconfirmed (CRu): Disappearance of all disease with the exception of residual lymph nodes that are 1.5 cm or less in greatest transverse diameter and/or indeterminate bone marrow findings.

Progression-free survival (PFS) is defined as the time from randomization into the study to the first observation of documented disease progression or death due to any cause.

Progressive Disease (PD) is characterized by any of the following:

• An increase of at least 50% in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal lymph node(s) or other disease sites.
• The appearance of any new lesion during or after treatment.
• An increase of at least 50% in the longest diameter of a previously identified node that was 1 cm or more in its short axis.
• An increase of at least 50% in the size of other lesions (e.g., splenomegaly, hepatomegaly).

Based on Kaplan-Meier estimates.

The Complete Response Rate (CR) is the percentage of participants who achieve confirmed complete response (CR) at 120 weeks as assessed per Independent Central Review.

• Complete Response (CR): Disappearance of all evidence of disease.

Event Free Survival (EFS) is defined as the time a participant remains free from certain negative events (disease progression, relapse, initiation of a new anti-lymphoma treatment, or death) between the date of randomization to the date of first documented progression, relapse, and initiation of a new anti-lymphoma treatment or death by any cause. Responding participants and those lost to follow up were censored at their last tumor assessment date.

Progressive Disease (PD) is characterized by any of the following:

• An increase of at least 50% in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal lymph node(s) or other disease sites.
• The appearance of any new lesion during or after treatment.
• An increase of at least 50% in the longest diameter of a previously identified node that was 1 cm or more in its short axis.
• An increase of at least 50% in the size of other lesions (e.g., splenomegaly, hepatomegaly).

Based on Kaplan-Meier estimates.

Overall survival (OS) is defined as the median length of time a participant stays alive from randomization. Participants who died, regardless of the cause of death, were considered to have had an event. Participants who withdrew consent for the study were considered censored at the time of withdrawal. Participants who completed the study and were still alive at the time of the clinical data cut-off date were censored. All participants who were lost to follow-up prior to the clinical data cut-off date were also considered censored at the time of last contact. Based on Kaplan-Meier estimates.

Time to Next Lymphoma Treatment (TTNLT) was measured from the date of randomization to the date of the first documented administration of any new anti-lymphoma treatment (such as chemotherapy, radiotherapy, radio-immunotherapy, or immunotherapy). Participants who continued to respond to treatment or who were lost to follow-up were considered censored on their last visit date. Participants who died (due to any cause) before receiving a new anti-lymphoma treatment were included in the statistical analysis, with death being counted as an event. Based on Kaplan-Meier estimates.