Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)

PFS was defined as the time from randomization to disease progression or death due to any cause, whichever occurred first, censored at the last tumor evaluation date. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.44.

Time frame: Baseline until disease progression or death or up to 1 year after last dose of study drug

Population: Intent-to-treat population included all participants who were randomized in to the study.

Overall survival was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. Participants who withdrew or lost to follow-up from study without having death documented were censored at the date of last contact. Kaplan-Meier estimates of the probability of survival at 6, 12 and 24 months was used to estimate the survival function.

Time frame: Baseline up to Month 6, 12, 24

Population: Intent-to-treat population included all participants who were randomized in to the study.

OR was based on assessment of complete response(CR),unconfirmed CR(Cru),partial response(PR) as per International Response Criteria for Non-Hodgkin's Lymphoma.Confirmed response=response persists on repeat imaging at least 4 weeks after initial response.CR=complete disappearance of all detectable clinical/radiographic evidence of disease,lymph nodes regressed to normal size \[at least 1.5 centimeter(cm) or less\],spleen regressed,not palpable on physical examination,bone marrow infiltrate cleared on repeat aspiration/biopsy.PR=at least 50 percent (%) decrease in sum of product diameters of 6 greatest dominant nodes,no increase in other nodes,liver/spleen,no new sites of disease. CRu=residual lymph node greater than 1.5 cm in transverse diameter that has regressed more than 75% in product diameter.Individual nodes previously confluent,regressed more than 75% in product diameters.Indeterminate bone marrow (increased number/size of lymph aggregates without cytologic/architectural atypia).

Time frame: Baseline, every 6 to 12 weeks during treatment period, end of treatment (EOT) (42 days after last dose), every 12 weeks during follow-up for up to 1 year after the last dose of study drug

Population: Intent-to-treat population included all participants who were randomized in to the study.

Time frame: 0, 1, 168 hours on Cycle 1, 2; 0, 1, 2, 168 hours on Cycle 3, 4

Population: Data for this outcome measurement was not collected since pharmacokinetic parameters were not analyzed in this study due to very few number of participants with PK samples.

Criteria for laboratory test abnormality: Blood Chemistry (alkaline phosphatase \[greater than{\>}5\*upper limit of normal {ULN}, calcium \[less than {\<}1.75 millimole per liter {mmol/L}, creatinine \[\>3\*ULN\], glucose \[\>13.9 mmol/L\], phosphorous \[\<0.6 mmol/L\], potassium \[\<3 mmol/L\], aspartate transaminase \[\>5.0\*ULN\], total bilirubin \[\>3\*ULN\]), Coagulation (international normalized ratio \[\>2\*ULN\]), Hematology (hemoglobin \[\<80 grams/Liter\], lymphocytes \[\<0.5\*10\^9/L\], absolute neutrophil count \[\<1\*10\^9/L\], platelet count \[\<50\*10\^9/L\], WBC \[\<2.0\*10\^9/L\]).

Time frame: Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)

Population: Safety population included all participants who received at least 1 dose of a test article (either rituximab + inotuzumab ozogamicin or control regimens R-CVP + R-FND).

Assessments of QT interval was performed only in rituximab + inotuzumab ozogamicinin group. QT interval corrected using Fridericia's formula (QTcF) and Bazett's formula (QTcB) was analyzed as per common terminology criteria for adverse events (CTCAE) version 3.0, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening or disabling AE, Grade 5 = death related to AE. Number of participants with change in CTCAE grading at post-baseline time point compared to the baseline were presented. The post-baseline value was defined as the maximum grade after the first dose date on or before the end of treatment.

Time frame: Baseline up to 42 days post-treatment

Population: Safety population included all participants who received at least 1 dose of a test article. Here 'N' signifies those participants who were evaluable for this outcome measure.

Criteria for determining significant change from baseline in vital signs abnormalities: heart rate value of \<40 beats per minute and value \>150 beats per minute, systolic blood pressure (SBP) of \<80 or \>210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of \<40 or \>130 mmHg, temperature \<32 or \>40 degree centigrade, and body weight\>=10% increase or decrease of body weight in kilogram (kg).

Time frame: Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)

Population: Safety population included all participants who received at least 1 dose of a test article (either rituximab + inotuzumab ozogamicin or control regimens R-CVP + R-FND).

AE=any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. TEAE=between first dose of study drug and up to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Time frame: Baseline up to 42 days post-treatment

Population: Safety population included all participants who received at least 1 dose of a test article (either rituximab + inotuzumab ozogamicin or control regimens R-CVP + R-FND).