Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy

A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Maintenance Treatment Versus no Further Treatment in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL) Who Have Responded to Induction Therapy

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01039376

Acronym

PROLONG

Enrollment

480

Registered

2009-12-25

Start date

2010-05-06

Completion date

2018-06-26

Last updated

2019-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukaemia, Lymphocytic, Chronic

Keywords

maintenance therapy, anti-CD20 monoclonal antibody, ofatumumab

Brief summary

The purpose of this study was to determine if maintenance therapy with ofatumumab would prolong remission in patients with CLL who have responded to second or third line treatment. This study would also evaluate the safety of ofatumumab maintenance compared to observation (the current standard of care). This study was co-developed with the HOVON and NORDIC CLL group and would be conducted as a collaborative effort with GSK.

Detailed description

The study met its primary objective at the protocol defined interim analysis (data cut-off 19-Jun-2014). The protocol-defined final analysis of the primary endpoint was performed when 280 PFS events were reached (data cut-off 20-Feb-2017).

Interventions

BIOLOGICALOfatumumab

Ofatumumab for maintenance therapy as IV infusions every 8 weeks . The first dose was 300 mg followed 1 week later by 1000 mg and 1000 mg every 8 weeks thereafter for up to 2 years.

OTHERObservation

Observation/Safety Evaluation

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Adults with documented diagnosis of CLL based on the modified IWCLL updated NCI-WG guidelines (Hallek, 2008) * At least PR according to the revised 2008 NCI-WG CLL criteria, within 3 months of the response assessment after the last dose of 2nd/3rd line treatment * The anti-leukemic treatment before study entry should have been at least 3 months or 3 cycles * ECOG Performance Status of 0-2 * Signed written informed consent prior to performing any study-specific procedures

Exclusion criteria

* Known primary or secondary fludarabine-refractory subjects, defined as treatment failure (failure to achieve a CR or PR) or disease progression within 6 months * Prior maintenance therapy * Known transformation of CLL (eg.Richter's transformation), prolymphocytic leukemia (PLL), or CNS involvement of CLL * Active Autoimmune hemolytic anemia (AIHA) requiring treatment except if in the opinion of the investigator and medical monitor it is thought not to affect the subject's safety, the conduct of the study or the interpretation of the data * Previous autologous or allogeneic stem cell transplantation * Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis B or C * Other past or current malignancy (with the exception of basal cell carcinoma or the skin or in situ carcinoma of the cervix or breasts) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry except if in the opinion of the investigator and medical monitor it is thought not to affect the subject's safety, the conduct of the study or the interpretation of the data * Clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months prior to screening, congestive heart failure, and arrhythmia requiring therapy, with the exception of exta systoles or minor conduction abnormalities except if in the opinion of the investigator and medical monitor it is thought not to affect the subject's safety, the conduct of the study or the interpretation of the data * History of significant cerebrovascular disease or event with symptoms or sequelae * Significant concurrent, uncontrolled medical condition that in the opinion of the investigator or GSK medical monitor contraindicates participation in this study * Other anti-leukemic use of medications including glucocorticoids * Known HIV positive * Screening laboratory values: platelets \<50 x 10x9/L, neutrophils\<1.0 x 10x9/L, Creatinine \> 1.5 X upper normal limit (unless normal creatinine clearance), total bilirubin \>1.5 X upper normal limit, ALT \>2.5 X upper normal limit (unless due to liver involvement of CLL), alkaline phosphase \> 2.5 X upper normal limit * Known or suspected hypersensitivity to ofatumumab that in the opinion of the investigator or medical monitor contraindicates study participation * Subjects who have received treatment with any non-marketed drug substance or experimental therapy within 5-terminal half-lives or 4 weeks whichever is longer prior to first dose of study medication or currently participating in any other interventional clinical study * Lactating women, women with a positive pregnancy test at Visit 1 or women (of childbearing potential) as well as men with partners of childbearing potential, who are not willing to use adequate contraception from study start through one year following last ofatumumab dose. Adequate contraception is defined as abstinence, oral hormonal birth control, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partner sterilization if male partner is sole partner for that subject. For females in the USA, the use of a double barrier method is also considered adequate (condom or occlusive cap plus spermicidal agent).

Design outcomes

Primary

Measure	Time frame	Description
Progression-free Survival, as Assessed by the Investigator	From randomization until progression or death (up to 79 months)	Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the investigator according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (\>1.5 centimeter \[cm\]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.
Progression-free Survival, as Assessed by the Independent Review Committee (IRC)	From randomization until progression or death (up to 79 months)	Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the IRC according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (\>1.5 centimeter \[cm\]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.

Secondary

Measure	Time frame	Description
Time to Next Therapy	From randomization until the end of the study (up to 88 months)	Time to next therapy is defined as the time from randomization to the date of receiving the next CLL treatment.
Progression-free Survival After Next-line Therapy	From randomization until progression or death (up to 88 months)	Progression-free survival after next-line therapy is defined as the time from randomization until progression or death following the next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy and who did not have progression or death after next-line therapy were censored at their last date of contact. Participant who died prior to next-line therapy, was counted as an event.
Time to Progression After Next-line Therapy	From randomization until progression or death (up to 88 months)	Time to progression after next-line therapy is defined as the time from progression following randomization until progression or death following next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy with a PD prior to receiving next line therapy and who did not had progression or death after next-line therapy were censored at their last date of contact. If a participant died prior to next-line therapy, this was counted as an event.
Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)	From randomization until the end of the study (up to 47 months)	The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales - fatigue (2 items), treatment side effects (\[TSE\], 4 items), disease symptoms (disease effects scale \[DES\], 4 items), and infection (4 items) - and single-item scales (social activities \[Social Problems (SP) Scale\] and future health worries \[Future Health (FH) Scale\]). These are measured on a four-point Likert scale, where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 - 100, where 0 = no symptoms or problems and 100 = severe symptoms or problems. Changes from Baseline were analyzed by a mixed model-repeated measures analysis of covariance (ANCOVA).
Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	From randomization until the end of the study (up to 47 months)	The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items), pain (2 items), fatigue (3 items), nausea and vomiting (2 items), five single-item symptom scores (insomnia, loss of appetite, constipation, diarrhea, and dyspnea), a single item asking about financial difficulties, and global health status/quality of life (QOF) consisting of 2 items. Functional and symptoms scales were measured on a four-point Likert scale, where 1 = not at all and 4 = very much, whereas global health status or QOF was assessed using a 7-item Likert scale, ranging from poor (worse quality of life) to excellent (better quality of life). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA.
Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale	From screening until the end of the study (up to 47 months)	EQ-5D is comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score. The utility score measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (level 1 = no problem; level 2 = some or moderate problem\[s\] and level 3 = unable, or extreme problems). Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA. A negative adjusted mean change from Baseline represents a worsening of quality of life.
Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	From randomization until the end of the study (up to 88 months)	Improvement is defined as a decrease from Baseline by at least one step on the ECOG performance status scale (improvement categorized as yes or no). Improvement in ECOG performance status was measured.
Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	From Screening until the end of the study (up to 88 months)	Participants with the indicated constitutional or B-symptoms (night sweats \[without signs of infection\]; unintentional weight loss \>= 10% within the previous 6 months; recurrent, unexplained fever of \> 38 degrees celcius or 100.5 degrees fahrenheit for 2 weeks; and extreme fatigue) were presented. The proportion of participants with no night sweats, no weight loss, no fever and no extreme fatigue were summarized.
Number of Participants With Grade 3 and Above Adverse Event of Infection	From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 26 months)	Participants with Grade 3, Grade 4 and Grade 5 adverse event of infection are presented. Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.0 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death).
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)	From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 for AEs (up to 26 months) and until end of study for SAEs (88 months)	An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 for AEs (up to 26 months) and until the end of the study for SAEs (88 months)	Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. Number of participants who reported myelosuppression (anemia \[low hemoglobin count\], neutropenia \[low neutrophil count\], and thrombocytopenia \[low platelet count\]) are presented. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).
Overall Survival	From randomization until death (up to 88 months)	Overall survival is defined as time from randomization to date of death.
Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA)	From randomization until the end of the study (up to 88 months)	AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented.
Number of Participants With a Positive Anti-ofatumumab Antibody (Human Anti-human Antibody; HAHA) Result	Pre-dose (Visit 1), Months 7, 13, 19, and 25 during treatment and at 3 and 6 months after last ofatumumab dose (up to 30 months)	All serum samples for analysis of HAHA were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA positive and further evaluated in the titration test to obtain a titer of HAHA. A confirmed positive result at any time point means the participant is positive for HAHA.Results are reported as the number of participants positive for HAHA.
Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	Baseline, every six months during treatment, and after last treatment visit and/or upon relapse (up to 88 months)	Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-baseline value minus the Baseline value.
Number of Participants Who Were Positive and Negative for Minimal Residual Disease (MRD) at Any Visit	From randomization until the end of the study (up to 88 months)	MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed complete remission. Number of participants who were positive and negative for minimal residual disease (MRD) at any visit is presented.
Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	Baseline and every two months from Month 3 until Month 25 and at every followup (up to 88 months)	CD5+CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5+CD19+ and CD5-CD19+ cell count value is the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	From Baseline until the end of the study (up to 79 months)	Blood samples were collected for the assessment of the following prognostic markers at Baseline (BL) and upon relapse: immunoglobulin heavy chain variable region (IgVH) mutational status; VH3-21 usage; Cytogenetics (by fluorescent in situ hybridization \[FISH\]) including 6q-, 11q-, +12q, 17p-, 13q- deletions; beta 2 microglobulin. Cox-regression model was used to explore the relationship between progression-free survival and the following explanatory variables: treatment group, cytogenetics (analyzed by FISH) at BL, IgVH mutational status at BL, beta 2 microglobulin at BL, BL CD20 and BL complement level. For each covariate, a hazard ratio \<1 indicates a lower risk on the first effect tested compared with the other effects tested. Cytogenetics Group (based on \>=20%)=CY G.
Cmax and Ctrough of Ofatumumab	Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)	Blood samples were collected to assess the plasma concentration of ofatumumab. Maximum concentration (Cmax) and observed drug concentration prior to the next dose (Ctrough) were determined. Blood samples were collected at pre-dose and 0.5 hours after the end of the infusion at treatment on Month 1 Week 1 (Day 1), Month 1 Week 2 (Day 8), and at every second infusion.
Total Plasma Clearance (CL) of Ofatumumab	Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)	Plasma clearance is defined as the plasma volume that is cleared of drug per unit of time.
AUC(0-tau) of Ofatumumab	Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)	Area under the concentration time curve over the dosing interval (AUC\[0-tau\]) is a measure of the drug exposure over time.
Vss of Ofatumumab	Day 1 Month 1 ( Cycle 1) through Month 7 ( Cycle 4)	Volume of distribution at steady state (Vss) is defined as the apparent volume of distribution of a drug between plasma and the rest of the body at steady state. Data from all time points collected were used to calculate one Vss value for each individual.
Plasma Half-life (t1/2) of Ofatumumab	Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)	The terminal half life (t1/2) of ofatumumab is defined as the time required for the plasma concentration of ofatumumab to reach half of its original value.
Number of Participants Who Received at Least One Transfusion During the Study	From randomization until the end of the study (up to 88 months)	Participants who received at least one transfusion (any blood products or blood supportive care product) during the study are presented.
Number of Participants With Improvement in Response From Baseline	From Baseline until the end of the study (up to 88 months)	Improvement in response was assessed by calculating the percentage of participants who changed from partial response (PR) at Baseline to complete response during the study.

Countries

Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Greece, Hungary, India, Israel, Italy, Netherlands, Norway, Poland, Puerto Rico, Russia, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, United States

Participant flow

Pre-assignment details

Eligible participants were stratified based on complete or partial remission at study entry, number of previous induction treatments (2 versus 3) and type of prior treatment (chemoimmunotherapy, only alkylating monotherapy, or other treatment). Participants were then randomized in a 1:1 ratio to receive ofatumumab or no further treatment.

Participants by arm

Arm	Count
Ofatumumab Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.	240
Observation Participants with relapsed CLL received no treatment and were under observation for up to 2 years.	240
Total	480

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	5	12
Overall Study	Physician Decision	15	10
Overall Study	Study terminated by Sponsor	90	72
Overall Study	Withdrawal by Subject	20	32

Baseline characteristics

Characteristic	Ofatumumab	Observation	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	119 Participants	120 Participants	239 Participants
Age, Categorical Between 18 and 65 years	121 Participants	120 Participants	241 Participants
Age, Continuous	63.9 Years STANDARD_DEVIATION 10.31	64.1 Years STANDARD_DEVIATION 9.61	64.0 Years STANDARD_DEVIATION 9.96
Race/Ethnicity, Customized Hispanic/Latino	15 Participants	18 Participants	33 Participants
Race/Ethnicity, Customized Missing	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Not Hispanic/Latino	225 Participants	221 Participants	446 Participants
Sex: Female, Male Female	79 Participants	80 Participants	159 Participants
Sex: Female, Male Male	161 Participants	160 Participants	321 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	88 / 239	87 / 241	175 / 480
other Total, other adverse events	202 / 239	139 / 241	341 / 480
serious Total, serious adverse events	120 / 239	120 / 241	240 / 480

Outcome results

Primary

Progression-free Survival, as Assessed by the Independent Review Committee (IRC)

Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the IRC according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (\>1.5 centimeter \[cm\]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.

Time frame: From randomization until progression or death (up to 79 months)

Population: Intent-to-Treat (ITT) Population: all participants who were randomized in the study.

Arm	Measure	Value (MEDIAN)
Ofatumumab	Progression-free Survival, as Assessed by the Independent Review Committee (IRC)	33.74 Months
Observation	Progression-free Survival, as Assessed by the Independent Review Committee (IRC)	14.98 Months

p-value: <0.000195% CI: [0.42, 0.68]Stratified log rank test

Primary

Progression-free Survival, as Assessed by the Investigator

Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the investigator according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (\>1.5 centimeter \[cm\]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.

Time frame: From randomization until progression or death (up to 79 months)

Population: Intent-to-Treat (ITT) Population: all participants who were randomized in the study.

Arm	Measure	Value (MEDIAN)
Ofatumumab	Progression-free Survival, as Assessed by the Investigator	34.17 Months
Observation	Progression-free Survival, as Assessed by the Investigator	16.89 Months

p-value: <0.000195% CI: [0.43, 0.7]Stratified log rank test

Secondary

AUC(0-tau) of Ofatumumab

Area under the concentration time curve over the dosing interval (AUC\[0-tau\]) is a measure of the drug exposure over time.

Time frame: Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)

Population: PK Population. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Ofatumumab	AUC(0-tau) of Ofatumumab	Cycle 1 Week 1	6113 microgramshour per mL (µghour/mL)	Geometric Coefficient of Variation 38
Ofatumumab	AUC(0-tau) of Ofatumumab	Cycle 1 Week 2	104013 microgramshour per mL (µghour/mL)	Geometric Coefficient of Variation 43
Ofatumumab	AUC(0-tau) of Ofatumumab	Cycle 4	122782 microgramshour per mL (µghour/mL)	Geometric Coefficient of Variation 50

Secondary

Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)

The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales - fatigue (2 items), treatment side effects (\[TSE\], 4 items), disease symptoms (disease effects scale \[DES\], 4 items), and infection (4 items) - and single-item scales (social activities \[Social Problems (SP) Scale\] and future health worries \[Future Health (FH) Scale\]). These are measured on a four-point Likert scale, where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 - 100, where 0 = no symptoms or problems and 100 = severe symptoms or problems. Changes from Baseline were analyzed by a mixed model-repeated measures analysis of covariance (ANCOVA).

Time frame: From randomization until the end of the study (up to 47 months)

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)	Disease Effects Scale	0.36 Scores on a scale	Standard Deviation 1.81
Ofatumumab	Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)	Fatigue Scale	-0.16 Scores on a scale	Standard Deviation 2.96
Ofatumumab	Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)	Treatment Side Effects Scale	-0.54 Scores on a scale	Standard Deviation 1.77
Ofatumumab	Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)	Future Health Scale	-8.66 Scores on a scale	Standard Deviation 3.69
Ofatumumab	Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)	Infection Scale	0.77 Scores on a scale	Standard Deviation 2.2
Ofatumumab	Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)	Social Problems Scale	5.69 Scores on a scale	Standard Deviation 3.2
Observation	Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)	Treatment Side Effects Scale	1.95 Scores on a scale	Standard Deviation 1.74
Observation	Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)	Disease Effects Scale	2.56 Scores on a scale	Standard Deviation 1.78
Observation	Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)	Infection Scale	0.25 Scores on a scale	Standard Deviation 2.17
Observation	Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)	Fatigue Scale	3.63 Scores on a scale	Standard Deviation 2.93
Observation	Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)	Social Problems Scale	10.02 Scores on a scale	Standard Deviation 3.16
Observation	Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)	Future Health Scale	-5.08 Scores on a scale	Standard Deviation 3.65

p-value: 0.019995% CI: [-4.04, -0.35]Repeated measures analysis of covariance

p-value: 0.008595% CI: [-6.61, -0.97]Repeated measures analysis of covariance

p-value: 0.064295% CI: [-7.37, 0.21]Repeated measures analysis of covariance

p-value: 0.639895% CI: [-1.67, 2.72]Repeated measures analysis of covariance

p-value: 0.005595% CI: [-7.37, -1.28]Repeated measures analysis of covariance

p-value: 0.006395% CI: [-4.27, -0.71]Repeated measures analysis of covariance

Secondary

Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points

CD5+CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5+CD19+ and CD5-CD19+ cell count value is the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Time frame: Baseline and every two months from Month 3 until Month 25 and at every followup (up to 88 months)

Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 6M FU	22.6 Cells per microliter	Standard Deviation 428.7
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 9M FU	1411.3 Cells per microliter	Standard Deviation 6965.41
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 36M FU	-354.8 Cells per microliter	Standard Deviation 2767.77
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C10 W73, M19	3.3 Cells per microliter	Standard Deviation 421.97
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 21M FU	16.2 Cells per microliter	Standard Deviation 450.95
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 36M FU	141.1 Cells per microliter	Standard Deviation 179.33
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 42M FU	113.3 Cells per microliter	Standard Deviation 131.48
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 57M FU	138.3 Cells per microliter	Standard Deviation 196.32
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C2 W9, M3	-284.1 Cells per microliter	Standard Deviation 2101.26
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C3 W17, M5	52.0 Cells per microliter	Standard Deviation 3554.94
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C4 W25, M7	-177.6 Cells per microliter	Standard Deviation 4105.41
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C5 W33, M9	-113.6 Cells per microliter	Standard Deviation 3336.44
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C6 W41, M11	-450.3 Cells per microliter	Standard Deviation 2851.41
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C7 W49, M13	-505.3 Cells per microliter	Standard Deviation 2716.66
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C8 W57, M15	-625.9 Cells per microliter	Standard Deviation 3003.35
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C9 W65, M17	-649.5 Cells per microliter	Standard Deviation 3057.32
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C10 W73, M19	-238.6 Cells per microliter	Standard Deviation 4061.13
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C11 W81, M21	-579.0 Cells per microliter	Standard Deviation 3446.95
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C12 W89, M23	-569.5 Cells per microliter	Standard Deviation 3510.43
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C13 W97, M25	-361.3 Cells per microliter	Standard Deviation 2702.79
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 3M FU	121.1 Cells per microliter	Standard Deviation 5479.03
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 6M FU	1968.3 Cells per microliter	Standard Deviation 15975.52
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 12M FU	2198.5 Cells per microliter	Standard Deviation 10743.58
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 15M FU	-84.4 Cells per microliter	Standard Deviation 4140.77
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 18M FU	1844.1 Cells per microliter	Standard Deviation 10091.28
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 21M FU	-395.1 Cells per microliter	Standard Deviation 4521.3
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 24M FU	279.4 Cells per microliter	Standard Deviation 6250.23
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 27M FU	-368.6 Cells per microliter	Standard Deviation 4829.16
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 30M FU	-354.4 Cells per microliter	Standard Deviation 5686.14
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 33M FU	-397.0 Cells per microliter	Standard Deviation 2767.27
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 39M FU	-163.7 Cells per microliter	Standard Deviation 3116.92
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 42M FU	-81.7 Cells per microliter	Standard Deviation 3426.53
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 45M FU	466.9 Cells per microliter	Standard Deviation 919.6
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 48M FU	1255.3 Cells per microliter	Standard Deviation 2289.34
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 51M FU	4341.4 Cells per microliter	Standard Deviation 8803.05
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 54M FU	1689.8 Cells per microliter	Standard Deviation 2357.27
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 57M FU	703.3 Cells per microliter	Standard Deviation 898.82
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 60M FU	237.0 Cells per microliter	Standard Deviation 326.68
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, withdrawal	8916.4 Cells per microliter	Standard Deviation 25922.35
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C2 W9, M3	-17.9 Cells per microliter	Standard Deviation 588.42
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C3 W17, M5	5.2 Cells per microliter	Standard Deviation 358.12
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C4 W25, M7	73.9 Cells per microliter	Standard Deviation 687.62
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C5 W33, M9	87.5 Cells per microliter	Standard Deviation 971.22
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C6 W41, M11	-13.1 Cells per microliter	Standard Deviation 257.81
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C7 W49, M13	5.3 Cells per microliter	Standard Deviation 368.66
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C8 W57, M15	-13.3 Cells per microliter	Standard Deviation 279.89
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C9 W65, M17	-4.4 Cells per microliter	Standard Deviation 349.91
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C11 W81, M21	-20.7 Cells per microliter	Standard Deviation 303.21
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C12 W89, M23	-13.5 Cells per microliter	Standard Deviation 306.57
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C13 W97, M25	7.9 Cells per microliter	Standard Deviation 103.85
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 3M FU	27.4 Cells per microliter	Standard Deviation 522.67
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 9M FU	13.2 Cells per microliter	Standard Deviation 368.63
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 12M FU	86.4 Cells per microliter	Standard Deviation 769.73
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 15M FU	10.8 Cells per microliter	Standard Deviation 393.47
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 18M FU	84.7 Cells per microliter	Standard Deviation 146.38
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 24M FU	574.7 Cells per microliter	Standard Deviation 2993.58
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 27M FU	102.0 Cells per microliter	Standard Deviation 643.44
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 30M FU	38.7 Cells per microliter	Standard Deviation 271.84
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 33M FU	98.3 Cells per microliter	Standard Deviation 117.18
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 39M FU	134.3 Cells per microliter	Standard Deviation 167.33
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 45M FU	108.6 Cells per microliter	Standard Deviation 140.97
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 48M FU	147.7 Cells per microliter	Standard Deviation 185.1
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 51M FU	162.6 Cells per microliter	Standard Deviation 229.87
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 54M FU	221.2 Cells per microliter	Standard Deviation 217.75
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 60M FU	180.5 Cells per microliter	Standard Deviation 222.74
Ofatumumab	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, withdrawal	593.5 Cells per microliter	Standard Deviation 2028.89
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 51M FU	139.3 Cells per microliter	Standard Deviation 82.75
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 54M FU	237.5 Cells per microliter	Standard Deviation 251.02
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 9M FU	140.9 Cells per microliter	Standard Deviation 107.92
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 57M FU	186.0 Cells per microliter	Standard Deviation 145.66
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 39M FU	183.9 Cells per microliter	Standard Deviation 249.78
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 21M FU	175.9 Cells per microliter	Standard Deviation 158.31
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 33M FU	157.5 Cells per microliter	Standard Deviation 96.69
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 60M FU	278.5 Cells per microliter	Standard Deviation 392.44
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 12M FU	147.2 Cells per microliter	Standard Deviation 136.93
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, withdrawal	13991.9 Cells per microliter	Standard Deviation 23553.42
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 57M FU	195.5 Cells per microliter	Standard Deviation 17.68
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 42M FU	361.1 Cells per microliter	Standard Deviation 601.36
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C2 W9, M3	598.6 Cells per microliter	Standard Deviation 3155.69
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C2 W9, M3	81.1 Cells per microliter	Standard Deviation 781.76
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C3 W17, M5	750.5 Cells per microliter	Standard Deviation 1995.47
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 15M FU	154.8 Cells per microliter	Standard Deviation 120.86
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C4 W25, M7	2102.2 Cells per microliter	Standard Deviation 9866.31
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C3 W17, M5	50.7 Cells per microliter	Standard Deviation 168.87
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C5 W33, M9	1905.2 Cells per microliter	Standard Deviation 6104.84
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 60M FU	127.0 Cells per microliter	Standard Deviation 173.95
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C6 W41, M11	1550.9 Cells per microliter	Standard Deviation 5483.76
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C4 W25, M7	228.2 Cells per microliter	Standard Deviation 2037.16
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C7 W49, M13	1429.2 Cells per microliter	Standard Deviation 4408.69
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 18M FU	173.5 Cells per microliter	Standard Deviation 142.95
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C8 W57, M15	1107.6 Cells per microliter	Standard Deviation 3371.04
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C5 W33, M9	98.9 Cells per microliter	Standard Deviation 401.27
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C9 W65, M17	967.0 Cells per microliter	Standard Deviation 1826.9
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 45M FU	157.7 Cells per microliter	Standard Deviation 116.04
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C10 W73, M19	1146.0 Cells per microliter	Standard Deviation 1914.02
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C6 W41, M11	92.7 Cells per microliter	Standard Deviation 296.23
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C11 W81, M21	1656.7 Cells per microliter	Standard Deviation 2662.28
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 24M FU	223.2 Cells per microliter	Standard Deviation 200.06
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C12 W89, M23	1608.3 Cells per microliter	Standard Deviation 3220.2
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C7 W49, M13	77.5 Cells per microliter	Standard Deviation 125.81
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, C13 W97, M25	2059.0 Cells per microliter	Standard Deviation 4987.97
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 54M FU	315.0 Cells per microliter	Standard Deviation 43.84
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 3M FU	2143.9 Cells per microliter	Standard Deviation 4280.66
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C8 W57, M15	95.9 Cells per microliter	Standard Deviation 143.95
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 9M FU	4008.5 Cells per microliter	Standard Deviation 13550.03
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 27M FU	153.3 Cells per microliter	Standard Deviation 110.37
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 12M FU	2316.0 Cells per microliter	Standard Deviation 8763.12
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C9 W65, M17	128.3 Cells per microliter	Standard Deviation 294.11
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 15M FU	1246.2 Cells per microliter	Standard Deviation 2894.2
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C10 W73, M19	172.5 Cells per microliter	Standard Deviation 555.27
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 18M FU	1250.9 Cells per microliter	Standard Deviation 3182.14
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 48M FU	180.6 Cells per microliter	Standard Deviation 175.93
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 21M FU	1147.5 Cells per microliter	Standard Deviation 2191.69
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C11 W81, M21	127.2 Cells per microliter	Standard Deviation 150.18
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 24M FU	2354.0 Cells per microliter	Standard Deviation 6726.31
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 30M FU	142.9 Cells per microliter	Standard Deviation 106.57
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 27M FU	2250.8 Cells per microliter	Standard Deviation 5833.72
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C12 W89, M23	143.7 Cells per microliter	Standard Deviation 251.88
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 30M FU	2189.3 Cells per microliter	Standard Deviation 6246.05
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, withdrawal	552.7 Cells per microliter	Standard Deviation 1799.49
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 33M FU	3024.8 Cells per microliter	Standard Deviation 7543.26
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 36M FU	3668.4 Cells per microliter	Standard Deviation 8581.98
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, C13 W97, M25	184.0 Cells per microliter	Standard Deviation 403.97
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 39M FU	1217.1 Cells per microliter	Standard Deviation 2441.59
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 36M FU	215.2 Cells per microliter	Standard Deviation 298.9
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 42M FU	2005.9 Cells per microliter	Standard Deviation 4327.53
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 3M FU	145.7 Cells per microliter	Standard Deviation 229.93
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 45M FU	450.4 Cells per microliter	Standard Deviation 1031.86
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 6M FU	2363.5 Cells per microliter	Standard Deviation 4937
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 48M FU	643.4 Cells per microliter	Standard Deviation 1270.16
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5-CD19+, 6M FU	153.8 Cells per microliter	Standard Deviation 330.63
Observation	Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points	CD5+CD19+, 51M FU	1104.8 Cells per microliter	Standard Deviation 2004.49

Secondary

Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score

The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items), pain (2 items), fatigue (3 items), nausea and vomiting (2 items), five single-item symptom scores (insomnia, loss of appetite, constipation, diarrhea, and dyspnea), a single item asking about financial difficulties, and global health status/quality of life (QOF) consisting of 2 items. Functional and symptoms scales were measured on a four-point Likert scale, where 1 = not at all and 4 = very much, whereas global health status or QOF was assessed using a 7-item Likert scale, ranging from poor (worse quality of life) to excellent (better quality of life). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA.

Time frame: From randomization until the end of the study (up to 47 months)

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Role Functioning	-6.94 Scores on a scale	Standard Deviation 3.04
Ofatumumab	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Appetite Loss	-0.63 Scores on a scale	Standard Deviation 2.33
Ofatumumab	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Cognitive Functioning	-1.63 Scores on a scale	Standard Deviation 2.3
Ofatumumab	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Constipation	-1.71 Scores on a scale	Standard Deviation 2.3
Ofatumumab	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Diarrhoea	-1.99 Scores on a scale	Standard Deviation 2.23
Ofatumumab	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Dyspnoea	0.44 Scores on a scale	Standard Deviation 2.71
Ofatumumab	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Emotional Functioning	-0.83 Scores on a scale	Standard Deviation 2.47
Ofatumumab	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Fatigue	-0.02 Scores on a scale	Standard Deviation 2.89
Ofatumumab	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Financial Difficulties	4.09 Scores on a scale	Standard Deviation 3.31
Ofatumumab	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Nausea and Vomiting	0.28 Scores on a scale	Standard Deviation 1.12
Ofatumumab	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Pain	1.82 Scores on a scale	Standard Deviation 2.89
Ofatumumab	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Physical Functioning	-2.25 Scores on a scale	Standard Deviation 2.01
Ofatumumab	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Global Health Status/QOL	-0.17 Scores on a scale	Standard Deviation 2.52
Ofatumumab	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Social Functioning	-4.15 Scores on a scale	Standard Deviation 2.71
Ofatumumab	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Insomnia	-4.49 Scores on a scale	Standard Deviation 3.51
Observation	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Social Functioning	-7.80 Scores on a scale	Standard Deviation 2.69
Observation	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Financial Difficulties	5.85 Scores on a scale	Standard Deviation 3.26
Observation	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Appetite Loss	0.85 Scores on a scale	Standard Deviation 2.3
Observation	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Global Health Status/QOL	-1.94 Scores on a scale	Standard Deviation 2.49
Observation	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Cognitive Functioning	-3.03 Scores on a scale	Standard Deviation 2.29
Observation	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Nausea and Vomiting	1.50 Scores on a scale	Standard Deviation 1.11
Observation	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Constipation	0.27 Scores on a scale	Standard Deviation 2.27
Observation	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Role Functioning	-10.51 Scores on a scale	Standard Deviation 3
Observation	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Diarrhoea	-2.49 Scores on a scale	Standard Deviation 2.2
Observation	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Pain	4.87 Scores on a scale	Standard Deviation 2.87
Observation	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Dyspnoea	2.76 Scores on a scale	Standard Deviation 2.67
Observation	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Insomnia	-2.70 Scores on a scale	Standard Deviation 3.48
Observation	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Emotional Functioning	-4.72 Scores on a scale	Standard Deviation 2.44
Observation	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Physical Functioning	-4.07 Scores on a scale	Standard Deviation 2.01
Observation	Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Fatigue	4.61 Scores on a scale	Standard Deviation 2.85

p-value: 0.181695% CI: [-3.64, 0.69]Repeated measures analysis of covariance

p-value: 0.286395% CI: [-1.18, 3.97]Repeated measures analysis of covariance

p-value: 0.093295% CI: [-4.28, 0.33]Repeated measures analysis of covariance

p-value: 0.653395% CI: [-1.67, 2.66]Repeated measures analysis of covariance

p-value: 0.096395% CI: [-5.06, 0.42]Repeated measures analysis of covariance

p-value: 0.003795% CI: [1.27, 6.51]Repeated measures analysis of covariance

p-value: 0.001395% CI: [-7.45, -1.82]Repeated measures analysis of covariance

p-value: 0.290295% CI: [-5.02, 1.51]Repeated measures analysis of covariance

p-value: 0.060695% CI: [-2.49, 0.05]Repeated measures analysis of covariance

p-value: 0.039395% CI: [-5.93, -0.15]Repeated measures analysis of covariance

p-value: 0.096895% CI: [-0.33, 3.96]Repeated measures analysis of covariance

p-value: 0.144995% CI: [-0.61, 4.17]Repeated measures analysis of covariance

p-value: 0.025995% CI: [0.43, 6.7]Repeated measures analysis of covariance

p-value: 0.017595% CI: [0.64, 6.65]Repeated measures analysis of covariance

p-value: 0.320995% CI: [-5.33, 1.75]Repeated measures analysis of covariance

Secondary

Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale

EQ-5D is comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score. The utility score measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (level 1 = no problem; level 2 = some or moderate problem\[s\] and level 3 = unable, or extreme problems). Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA. A negative adjusted mean change from Baseline represents a worsening of quality of life.

Time frame: From screening until the end of the study (up to 47 months)

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale	Utility Score	-0.02 Scores on a scale	Standard Deviation 0.03
Ofatumumab	Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale	Thermometer Score	-0.37 Scores on a scale	Standard Deviation 2.05
Observation	Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale	Utility Score	-0.05 Scores on a scale	Standard Deviation 0.03
Observation	Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale	Thermometer Score	-1.75 Scores on a scale	Standard Deviation 2.04

p-value: 0.01195% CI: [0.01, 0.06]Repeated measures analysis of covariance

p-value: 0.199995% CI: [-0.73, 3.49]Repeated measures analysis of covariance

Secondary

Cmax and Ctrough of Ofatumumab

Blood samples were collected to assess the plasma concentration of ofatumumab. Maximum concentration (Cmax) and observed drug concentration prior to the next dose (Ctrough) were determined. Blood samples were collected at pre-dose and 0.5 hours after the end of the infusion at treatment on Month 1 Week 1 (Day 1), Month 1 Week 2 (Day 8), and at every second infusion.

Time frame: Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)

Population: Pharmacokinetic (PK) Population: all participants in the ITT Population for whom a PK sample was obtained and analyzed. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Ofatumumab	Cmax and Ctrough of Ofatumumab	Cmax, Cycle 1 Week 1	73.8 micrograms per milliliter (µg/mL)	Geometric Coefficient of Variation 65
Ofatumumab	Cmax and Ctrough of Ofatumumab	Cmax, Cycle 1 Week 2	264 micrograms per milliliter (µg/mL)	Geometric Coefficient of Variation 50
Ofatumumab	Cmax and Ctrough of Ofatumumab	Cmax, Cycle 4	275 micrograms per milliliter (µg/mL)	Geometric Coefficient of Variation 31
Ofatumumab	Cmax and Ctrough of Ofatumumab	Ctrough, Cycle 1 Week 2	16.3 micrograms per milliliter (µg/mL)	Geometric Coefficient of Variation 254
Ofatumumab	Cmax and Ctrough of Ofatumumab	Ctrough, Cycle 4	9.9 micrograms per milliliter (µg/mL)	Geometric Coefficient of Variation 1323

Secondary

Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points

Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-baseline value minus the Baseline value.

Time frame: Baseline, every six months during treatment, and after last treatment visit and/or upon relapse (up to 88 months)

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C10 W73, M19	-0.1 grams per liter	Standard Deviation 0.36
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 39M FU	0.3 grams per liter	Standard Deviation 2.53
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 60M FU	0.8 grams per liter	Standard Deviation 4.43
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C5 W33, M9	-0.1 grams per liter	—
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 51M FU	-0.0 grams per liter	Standard Deviation 0.06
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C3 W17, M5	0.0 grams per liter	Standard Deviation 0.12
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C4 W25, M7	-0.1 grams per liter	Standard Deviation 0.17
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C5 W33, M9	-0.0 grams per liter	—
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C6 W41, M11	0.0 grams per liter	—
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C7 W49, M13	-0.1 grams per liter	Standard Deviation 0.24
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C8 W57, M15	-0.1 grams per liter	Standard Deviation 0.15
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C9 W65, M17	-0.2 grams per liter	Standard Deviation 0.17
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C10 W73, M19	-0.1 grams per liter	Standard Deviation 0.2
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C11 W81, M21	-0.0 grams per liter	—
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C12 W89, M23	-0.3 grams per liter	—
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C13 W97, M25	-0.1 grams per liter	Standard Deviation 0.23
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 3M FU	-0.1 grams per liter	Standard Deviation 0.22
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 6M FU	-0.1 grams per liter	Standard Deviation 0.18
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 9M FU	-0.1 grams per liter	Standard Deviation 0.22
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 12M FU	-0.1 grams per liter	Standard Deviation 0.3
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 15M FU	-0.0 grams per liter	Standard Deviation 0.27
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 18M FU	0.1 grams per liter	Standard Deviation 0.57
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 21M FU	-0.1 grams per liter	Standard Deviation 0.4
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 24M FU	0.2 grams per liter	Standard Deviation 1.06
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 27M FU	0.1 grams per liter	Standard Deviation 0.7
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 30M FU	0.2 grams per liter	Standard Deviation 0.85
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 33M FU	0.4 grams per liter	Standard Deviation 1.48
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 36M FU	0.2 grams per liter	Standard Deviation 1.06
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 39M FU	0.2 grams per liter	Standard Deviation 0.86
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 42M FU	0.4 grams per liter	Standard Deviation 1.67
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 45M FU	-0.2 grams per liter	Standard Deviation 0.2
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 48M FU	-0.1 grams per liter	Standard Deviation 0.83
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 51M FU	0.3 grams per liter	Standard Deviation 1.15
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 54M FU	0.0 grams per liter	Standard Deviation 0.89
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 57M FU	-0.4 grams per liter	Standard Deviation 0.36
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 60M FU	-0.5 grams per liter	Standard Deviation 0.42
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, Withdrawal	0.0 grams per liter	Standard Deviation 0.53
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C3 W17, M5	0.0 grams per liter	Standard Deviation 1.17
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C4 W25, M7	-0.7 grams per liter	Standard Deviation 2.03
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C5 W33, M9	-1.0 grams per liter	—
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C6 W41, M11	-1.9 grams per liter	—
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C7 W49, M13	-1.1 grams per liter	Standard Deviation 1.9
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C8 W57, M15	-1.3 grams per liter	Standard Deviation 1.03
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C9 W65, M17	-3.7 grams per liter	Standard Deviation 4.96
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C10 W73, M19	-1.0 grams per liter	Standard Deviation 2.15
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C11 W81, M21	0.2 grams per liter	—
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C12 W89, M23	-0.5 grams per liter	—
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C13 W97, M25	-1.1 grams per liter	Standard Deviation 2.45
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 3M FU	-0.7 grams per liter	Standard Deviation 2.46
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 6M FU	-0.9 grams per liter	Standard Deviation 2.24
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 9M FU	-0.7 grams per liter	Standard Deviation 2.29
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 12M FU	-0.5 grams per liter	Standard Deviation 2.17
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 15M FU	-0.4 grams per liter	Standard Deviation 2.49
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 18M FU	-0.5 grams per liter	Standard Deviation 2.71
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 21M FU	-0.9 grams per liter	Standard Deviation 2.39
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 24M FU (	-0.1 grams per liter	Standard Deviation 2.17
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 27M FU	-0.3 grams per liter	Standard Deviation 2.32
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 30M FU	0.3 grams per liter	Standard Deviation 2.67
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 33M FU	0.7 grams per liter	Standard Deviation 2.91
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 36M FU	-0.1 grams per liter	Standard Deviation 2.71
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 42M FU	0.6 grams per liter	Standard Deviation 3.03
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 45M FU	-0.6 grams per liter	Standard Deviation 2.11
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 48M FU	-0.6 grams per liter	Standard Deviation 2.3
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 51M FU	0.1 grams per liter	Standard Deviation 3.25
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 54M FU	-1.0 grams per liter	Standard Deviation 2.35
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 57M FU	1.3 grams per liter	Standard Deviation 4.01
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, Withdrawal	-0.7 grams per liter	Standard Deviation 0.91
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C3 W17, M5	-0.0 grams per liter	Standard Deviation 0.09
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C4 W25, M7	-0.1 grams per liter	Standard Deviation 0.43
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C6 W41, M11	-0.5 grams per liter	—
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C7 W49, M13	-0.1 grams per liter	Standard Deviation 0.29
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C8 W57, M15	-0.0 grams per liter	Standard Deviation 0.05
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C9 W65, M17	-0.3 grams per liter	Standard Deviation 0.54
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C11 W81, M21	0.0 grams per liter	—
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C12 W89, M23	0.0 grams per liter	—
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C13 W97, M25	-0.1 grams per liter	Standard Deviation 0.45
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 3M FU	-0.0 grams per liter	Standard Deviation 0.35
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 6M FU (	-0.1 grams per liter	Standard Deviation 0.36
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 9M FU	-0.1 grams per liter	Standard Deviation 0.17
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 12M FU	-0.0 grams per liter	Standard Deviation 0.18
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 15M FU	-0.0 grams per liter	Standard Deviation 0.15
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 18M FU	0.1 grams per liter	Standard Deviation 0.25
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 21M FU	0.1 grams per liter	Standard Deviation 0.41
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 24M FU	0.0 grams per liter	Standard Deviation 0.14
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 27M FU	0.2 grams per liter	Standard Deviation 0.41
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 30M FU (n=18, 12)	0.1 grams per liter	Standard Deviation 0.17
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 33M FU	0.1 grams per liter	Standard Deviation 0.22
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 36M FU	0.2 grams per liter	Standard Deviation 0.28
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 39M FU	0.1 grams per liter	Standard Deviation 0.21
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 42M FU	0.1 grams per liter	Standard Deviation 0.23
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 45M FU	0.2 grams per liter	Standard Deviation 0.32
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 48M FU	0.1 grams per liter	Standard Deviation 0.28
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 54M FU	0.1 grams per liter	Standard Deviation 0.24
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 57M FU	0.2 grams per liter	Standard Deviation 0.49
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 60M FU	0.6 grams per liter	Standard Deviation 0.84
Ofatumumab	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, Withdrawal	0.3 grams per liter	Standard Deviation 0.73
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 6M FU	0.2 grams per liter	Standard Deviation 2.89
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C11 W81, M21	0.2 grams per liter	Standard Deviation 0.04
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 30M FU (n=18, 12)	-0.0 grams per liter	Standard Deviation 1.51
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 12M FU	-0.3 grams per liter	Standard Deviation 3.26
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C12 W89, M23	-0.0 grams per liter	Standard Deviation 0.11
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 15M FU	-0.1 grams per liter	Standard Deviation 3.29
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 48M FU	0.4 grams per liter	Standard Deviation 0.38
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 18M FU	-0.3 grams per liter	Standard Deviation 3.45
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C2 W9, M3	0.2 grams per liter	Standard Deviation 0.23
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C13 W97, M25	0.2 grams per liter	Standard Deviation 0.79
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C3 W17, M5	-0.1 grams per liter	Standard Deviation 0.24
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 21M FU	0.1 grams per liter	Standard Deviation 3.81
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C4 W25, M7	-0.0 grams per liter	Standard Deviation 0.41
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 33M FU	0.1 grams per liter	Standard Deviation 0.36
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C5 W33, M9	-0.0 grams per liter	Standard Deviation 0.01
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 24M FU (	0.0 grams per liter	Standard Deviation 3.43
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C6 W41, M11	-0.1 grams per liter	—
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 3M FU	0.3 grams per liter	Standard Deviation 1.3
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C7 W49, M13	-0.0 grams per liter	Standard Deviation 0.63
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 27M FU	-0.5 grams per liter	Standard Deviation 3.97
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C8 W57, M15	0.0 grams per liter	Standard Deviation 0.02
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 51M FU	0.3 grams per liter	Standard Deviation 0.39
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C9 W65, M17	0.1 grams per liter	Standard Deviation 0.04
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 30M FU	-0.9 grams per liter	Standard Deviation 4.83
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C10 W73, M19	0.1 grams per liter	Standard Deviation 0.37
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 6M FU (	0.4 grams per liter	Standard Deviation 1.6
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C11 W81, M21	0.2 grams per liter	Standard Deviation 0.21
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 33M FU	-1.1 grams per liter	Standard Deviation 5.63
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C12 W89, M23	0.2 grams per liter	Standard Deviation 0.39
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 36M FU	-0.3 grams per liter	Standard Deviation 1.31
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, C13 W97, M25	0.1 grams per liter	Standard Deviation 0.38
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 36M FU	-1.2 grams per liter	Standard Deviation 3.87
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 3M FU	0.2 grams per liter	Standard Deviation 0.37
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 39M FU	-0.9 grams per liter	Standard Deviation 5.6
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 6M FU	0.1 grams per liter	Standard Deviation 0.39
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 9M FU	0.6 grams per liter	Standard Deviation 2.93
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 9M FU	0.1 grams per liter	Standard Deviation 0.38
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 42M FU	0.9 grams per liter	Standard Deviation 4.82
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 12M FU	0.2 grams per liter	Standard Deviation 0.36
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, Withdrawal	-0.0 grams per liter	Standard Deviation 0.03
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 15M FU	0.2 grams per liter	Standard Deviation 0.44
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 45M FU	2.3 grams per liter	Standard Deviation 4
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 18M FU	0.1 grams per liter	Standard Deviation 0.25
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 12M FU	0.6 grams per liter	Standard Deviation 2.49
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 21M FU	0.1 grams per liter	Standard Deviation 0.34
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 48M FU	3.5 grams per liter	Standard Deviation 3.14
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 24M FU	0.1 grams per liter	Standard Deviation 0.37
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 39M FU	-0.4 grams per liter	Standard Deviation 1.54
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 27M FU	0.1 grams per liter	Standard Deviation 0.46
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 51M FU	2.4 grams per liter	Standard Deviation 4.02
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 30M FU	0.1 grams per liter	Standard Deviation 0.58
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 15M FU	0.3 grams per liter	Standard Deviation 1.08
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 33M FU	0.2 grams per liter	Standard Deviation 0.6
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 54M FU	5.6 grams per liter	Standard Deviation 4.14
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 36M FU	0.2 grams per liter	Standard Deviation 0.63
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 54M FU	0.5 grams per liter	Standard Deviation 0.26
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 39M FU	0.3 grams per liter	Standard Deviation 0.71
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 57M FU	5.3 grams per liter	Standard Deviation 5.68
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 42M FU	0.2 grams per liter	Standard Deviation 0.72
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 60M FU	4.6 grams per liter	Standard Deviation 4.28
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 45M FU	0.4 grams per liter	Standard Deviation 0.94
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 18M FU	1.2 grams per liter	Standard Deviation 4.95
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 48M FU	-0.0 grams per liter	Standard Deviation 0.25
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, Withdrawal	-1.5 grams per liter	Standard Deviation 1.86
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 51M FU	0.2 grams per liter	Standard Deviation 0.7
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C2 W9, M3	0.1 grams per liter	Standard Deviation 0.12
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 54M FU	0.7 grams per liter	Standard Deviation 1.34
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 42M FU	-0.6 grams per liter	Standard Deviation 1.79
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 57M FU	0.4 grams per liter	Standard Deviation 1.04
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C3 W17, M5	-0.0 grams per liter	Standard Deviation 0.06
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, 60M FU	0.4 grams per liter	Standard Deviation 1.05
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 21M FU	1.4 grams per liter	Standard Deviation 5.48
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgA, Withdrawal	-0.1 grams per liter	Standard Deviation 0.08
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C2 W9, M3	-0.4 grams per liter	Standard Deviation 0.21
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C4 W25, M7	0.1 grams per liter	Standard Deviation 0.42
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C3 W17, M5	0.2 grams per liter	Standard Deviation 0.39
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C5 W33, M9	-0.1 grams per liter	Standard Deviation 0.07
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C4 W25, M7	-0.1 grams per liter	Standard Deviation 1.83
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 60M FU	0.4 grams per liter	Standard Deviation 0.42
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C5 W33, M9	0.5 grams per liter	Standard Deviation 2.2
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C6 W41, M11	0.0 grams per liter	—
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C6 W41, M11	1.0 grams per liter	—
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 24M FU	2.0 grams per liter	Standard Deviation 8.19
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C7 W49, M13	0.2 grams per liter	Standard Deviation 2.88
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C7 W49, M13	0.2 grams per liter	Standard Deviation 0.9
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C8 W57, M15	-0.9 grams per liter	Standard Deviation 0.08
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 45M FU	0.2 grams per liter	Standard Deviation 0.27
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C9 W65, M17	0.9 grams per liter	Standard Deviation 0.71
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C8 W57, M15	-0.0 grams per liter	Standard Deviation 0.01
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C10 W73, M19	0.6 grams per liter	Standard Deviation 4.61
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 27M FU	-0.2 grams per liter	Standard Deviation 1.14
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C11 W81, M21	-0.3 grams per liter	Standard Deviation 1.39
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C9 W65, M17	0.3 grams per liter	Standard Deviation 0.49
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C12 W89, M23	0.2 grams per liter	Standard Deviation 0.89
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 9M FU	0.1 grams per liter	Standard Deviation 2.87
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, C13 W97, M25	0.3 grams per liter	Standard Deviation 3.02
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, C10 W73, M19	0.2 grams per liter	Standard Deviation 0.86
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgG, 3M FU	0.2 grams per liter	Standard Deviation 2.83
Observation	Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points	IgM, 57M FU	0.4 grams per liter	Standard Deviation 0.41

Secondary

Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA)

AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented.

Time frame: From randomization until the end of the study (up to 88 months)

Population: Safety Population

Arm	Measure	Group	Value (NUMBER)
Ofatumumab	Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA)	Haemolytic anaemia	2 Participants
Ofatumumab	Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA)	Autoimmune haemolytic anaemia	1 Participants
Ofatumumab	Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA)	Thrombocytopenic purpura	0 Participants
Observation	Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA)	Haemolytic anaemia	2 Participants
Observation	Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA)	Autoimmune haemolytic anaemia	4 Participants
Observation	Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA)	Thrombocytopenic purpura	1 Participants

Secondary

Number of Participants Who Received at Least One Transfusion During the Study

Participants who received at least one transfusion (any blood products or blood supportive care product) during the study are presented.

Time frame: From randomization until the end of the study (up to 88 months)

Population: Safety Population

Arm	Measure	Value (NUMBER)
Ofatumumab	Number of Participants Who Received at Least One Transfusion During the Study	96 Participants
Observation	Number of Participants Who Received at Least One Transfusion During the Study	64 Participants

Secondary

Number of Participants Who Were Positive and Negative for Minimal Residual Disease (MRD) at Any Visit

MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed complete remission. Number of participants who were positive and negative for minimal residual disease (MRD) at any visit is presented.

Time frame: From randomization until the end of the study (up to 88 months)

Population: ITT Population. Only those participants with data available at the specified time point were analyzed.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab	Number of Participants Who Were Positive and Negative for Minimal Residual Disease (MRD) at Any Visit	Positive	150 Participants
Ofatumumab	Number of Participants Who Were Positive and Negative for Minimal Residual Disease (MRD) at Any Visit	Negative	27 Participants
Observation	Number of Participants Who Were Positive and Negative for Minimal Residual Disease (MRD) at Any Visit	Positive	122 Participants
Observation	Number of Participants Who Were Positive and Negative for Minimal Residual Disease (MRD) at Any Visit	Negative	37 Participants

Secondary

Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points

Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. Number of participants who reported myelosuppression (anemia \[low hemoglobin count\], neutropenia \[low neutrophil count\], and thrombocytopenia \[low platelet count\]) are presented. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).

Time frame: From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 for AEs (up to 26 months) and until the end of the study for SAEs (88 months)

Population: Safety Population.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	SCR	7 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C11 unscheduled_2	1 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C12 W89/M23	3 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C4 Unscheduled	1 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C13 W97/M25	3 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C5 W33/M9	15 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C13, unscheduled	1 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	3M follow-up	2 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	6M follow-up	2 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C2, unscheduled	1 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	9M follow-up	2 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C5, unscheduled	1 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	12M follow-up	1 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C6 W41/M11	13 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	15M follow-up	1 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C1 W2/M1	13 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	18M follow-up	0 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C6 unscheduled_1	4 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	27M follow-up	0 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C6 unscheduled_2	1 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	30M follow-up	0 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C7 W49/M13	9 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	33M follow-up	1 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C3 W17/M5	18 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	60M follow-up	1 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C8 W57/M15	10 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	Withdrawal	11 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C1 W1/M1	1 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	Unscheduled_1	0 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	Unscheduled_2	0 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C9 W65/M17	5 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	Unscheduled_3	1 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C9, unscheduled	0 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C3, unscheduled	1 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C10 W73/M19	2 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C2 W9/M3	12 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C11 W81/M21	5 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C4 W25/M7	12 Participants
Ofatumumab	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C11 unscheduled_1	1 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	Unscheduled_3	0 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C9 W65/M17	1 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	Unscheduled_1	1 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	SCR	5 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C1 W1/M1	1 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C1 W2/M1	8 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C2 W9/M3	15 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C2, unscheduled	0 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C3 W17/M5	7 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C3, unscheduled	0 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C4 W25/M7	8 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C5 W33/M9	5 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C6 W41/M11	5 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C7 W49/M13	2 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C8 W57/M15	3 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C9, unscheduled	1 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C10 W73/M19	2 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C11 W81/M21	1 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C11 unscheduled_1	0 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C12 W89/M23	2 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	C13 W97/M25	2 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	6M follow-up	1 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	9M follow-up	1 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	12M follow-up	2 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	15M follow-up	0 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	18M follow-up	1 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	27M follow-up	1 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	30M follow-up	1 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	33M follow-up	0 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	60M follow-up	0 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	Withdrawal	8 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	Unscheduled_2	2 Participants
Observation	Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points	3M follow-up	1 Participants

Secondary

Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points

Improvement is defined as a decrease from Baseline by at least one step on the ECOG performance status scale (improvement categorized as yes or no). Improvement in ECOG performance status was measured.

Time frame: From randomization until the end of the study (up to 88 months)

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (NUMBER)
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C8 W57/M15	14 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	15M FU	4 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C3 W17/M5	16 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	18M FU	4 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C9 W65/M17	11 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	21M FU	3 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C1 W2/M1	10 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	24M FU	3 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C10 W73/M19	14 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	27M FU	3 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C4 W25/M7	18 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	30M FU	3 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C11 W81/M21	10 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	33M FU	3 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	42M FU	0 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	36M FU	3 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C12 W89/M23	11 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	39M FU	1 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C5 W33/M9	16 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	45M FU	0 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C13 W97/M25	9 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	48M FU	0 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C2 W9/M3	20 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	51M FU	0 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	3M FU	11 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	54M FU	1 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C6 W41/M11	14 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	57M FU	0 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	9M FU	5 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	60M FU	0 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	6M FU	9 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	Withdrawal	5 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	12M FU	6 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	Worst-Case Post Baseline	3 Participants
Ofatumumab	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C7 W49/M13	18 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	Worst-Case Post Baseline	5 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C7 W49/M13	14 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	6M FU	4 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	42M FU	0 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C1 W2/M1	12 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C2 W9/M3	17 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C3 W17/M5	17 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C4 W25/M7	16 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C5 W33/M9	18 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C6 W41/M11	12 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C8 W57/M15	15 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C9 W65/M17	12 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C10 W73/M19	10 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C11 W81/M21	9 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C12 W89/M23	7 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	C13 W97/M25	7 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	3M FU	6 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	9M FU	5 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	12M FU	5 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	15M FU	4 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	18M FU	3 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	21M FU	3 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	24M FU	2 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	27M FU	1 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	30M FU	1 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	33M FU	1 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	36M FU	1 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	39M FU	2 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	45M FU	1 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	48M FU	1 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	51M FU	1 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	54M FU	1 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	57M FU	1 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	60M FU	1 Participants
Observation	Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points	Withdrawal	10 Participants

Secondary

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.

Time frame: From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 for AEs (up to 26 months) and until end of study for SAEs (88 months)

Population: Safety Population

Arm	Measure	Group	Value (NUMBER)
Ofatumumab	Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)	Any AE	221 Participants
Ofatumumab	Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)	Any SAE	120 Participants
Observation	Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)	Any AE	198 Participants
Observation	Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)	Any SAE	120 Participants

Secondary

Number of Participants With a Positive Anti-ofatumumab Antibody (Human Anti-human Antibody; HAHA) Result

All serum samples for analysis of HAHA were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA positive and further evaluated in the titration test to obtain a titer of HAHA. A confirmed positive result at any time point means the participant is positive for HAHA.Results are reported as the number of participants positive for HAHA.

Time frame: Pre-dose (Visit 1), Months 7, 13, 19, and 25 during treatment and at 3 and 6 months after last ofatumumab dose (up to 30 months)

Population: Safety Population. Only those participants with post-ofatumumab HAHA results were analyzed.

Arm	Measure	Value (NUMBER)
Ofatumumab	Number of Participants With a Positive Anti-ofatumumab Antibody (Human Anti-human Antibody; HAHA) Result	1 Participants

Secondary

Number of Participants With Grade 3 and Above Adverse Event of Infection

Participants with Grade 3, Grade 4 and Grade 5 adverse event of infection are presented. Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.0 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death).

Time frame: From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 26 months)

Population: Safety Population: all participants who were randomized in the study and analyses were done based on the treatment the participant received regardless of how they were randomized.

Arm	Measure	Value (NUMBER)
Ofatumumab	Number of Participants With Grade 3 and Above Adverse Event of Infection	38 Participants
Observation	Number of Participants With Grade 3 and Above Adverse Event of Infection	23 Participants

Secondary

Number of Participants With Improvement in Response From Baseline

Improvement in response was assessed by calculating the percentage of participants who changed from partial response (PR) at Baseline to complete response during the study.

Time frame: From Baseline until the end of the study (up to 88 months)

Population: ITT Population. Only participants who had PR at study entry were analyzed.

Arm	Measure	Value (NUMBER)
Ofatumumab	Number of Participants With Improvement in Response From Baseline	16 Participants
Observation	Number of Participants With Improvement in Response From Baseline	8 Participants

Secondary

Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points

Participants with the indicated constitutional or B-symptoms (night sweats \[without signs of infection\]; unintentional weight loss \>= 10% within the previous 6 months; recurrent, unexplained fever of \> 38 degrees celcius or 100.5 degrees fahrenheit for 2 weeks; and extreme fatigue) were presented. The proportion of participants with no night sweats, no weight loss, no fever and no extreme fatigue were summarized.

Time frame: From Screening until the end of the study (up to 88 months)

Arm	Measure	Group	Value (NUMBER)
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C2 W9/M3, night sweats	6 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	SCR, night sweats	13 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C1 W2/M1, extreme fatigue	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C1 W2/M1, fever	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C1 W2/M1, night sweats	9 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C2 W9/M3, fever	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C2 W9/M3, weight loss	3 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C5 W33/M9, fever	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C13 W97/M25, extreme fatigue	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C7 W49/M13, extreme fatigue	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C7 W49/M13, fever	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C7 W49/M13, night sweats	3 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C7 W49/M13, weight loss	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C8 W57/M15, fever	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C8 W57/M15, night sweats	4 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C8 W57/M15, weight loss	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C9 W65/M17, extreme fatigue	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C9 W65/M17, fever	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C9 W65/M17, night sweats	7 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C9 W65/M17, weight loss	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C10 W73/M19, extreme fatigue	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C10 W73/M19, fever	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C10 W73/M19, night sweats	7 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C10 W73/M19, weight loss	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C11 W81/M21, extreme fatigue	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C11 W81/M21, night sweats	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C11 W81/M21, weight loss	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C12 W89/M23, extreme fatigue	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C12 W89/M23, night sweats	3 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C12 W89/M23, weight loss	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C13 W97/M25, fever	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C13 W97/M25, night sweats	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C13 W97/M25, weight loss	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	3M follow up, extreme fatigue	3 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	3M follow up, fever	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	3M follow up, night sweats	4 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	3M follow up, weight loss	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	6M follow up, fever	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	6M follow up, night sweats	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	6M follow up, weight loss	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	9M follow up, extreme fatigue	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	27M follow up, extreme fatigue	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	12M follow up, fever	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	12M follow up, night sweats	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	12M follow up, weight loss	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	15M follow up, extreme fatigue	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	15M follow up, fever	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	15M follow up, night sweats	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	15M follow up, weight loss	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	18M follow up, extreme fatigue	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	18M follow up, night sweats	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	21M follow up, weight loss	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	27M follow up, fever	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	27M follow up, night sweats	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	27M follow up, weight loss	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	30M follow up, extreme fatigue	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	30M follow up, fever	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	33M follow up, night sweats	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	33M follow up, weight loss	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	36M follow up, extreme fatigue	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	36M follow up, fever	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	39M follow up, weight loss	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	42M follow up, extreme fatigue	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	42M follow up, fever	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	42M follow up, night sweats	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	42M follow up,, weight loss	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	54M follow up, extreme fatigue	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	SCR, extreme fatigue	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	SCR, fever	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	SCR, weight loss	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C1 W2/M1, weight loss	4 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C2 W9/M3, extreme fatigue	3 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C3 W17/M5, extreme fatigue	4 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C3 W17/M5, fever	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C3 W17/M5, night sweats	6 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C3 W17/M5, weight loss	3 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C4 W25/M7, extreme fatigue (n=203, 187)	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C4 W25/M7, fever	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C4 W25/M7, night sweats	5 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C4 W25/M7, weight loss	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C5 W33/M9, extreme fatigue	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C5 W33/M9, night sweats fatigue	7 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C5 W33/M9, weight loss	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C6 W41/M11, extreme fatigue	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C6 W41/M11, fever	2 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C6 W41/M11, night sweats	7 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C6 W41/M11, weight loss	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C8 W57/M15, extreme fatigue	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C11 W81/M21, fever	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C12 W89/M23, fever	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	6M follow up, extreme fatigue	3 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	9M follow up, fever	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	9M follow up, night sweats	4 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	9M follow up, weight loss	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	12M follow up, extreme fatigue	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	18M follow up, fever	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	18M follow up, weight loss	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	21M follow up, extreme fatigue	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	21M follow up, fever	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	21M follow up, night sweats	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	30M follow up, night sweats	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	30M follow up, weight loss	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	33M follow up, extreme fatigue	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	33M follow up, fever	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	36M follow up, night sweats	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	36M follow up, weight loss	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	39M follow up, extreme fatigue	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	39M follow up, fever	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	39M follow up, night sweats	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	51M follow up, extreme fatigue	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	51M follow up, fever	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	51M follow up, night sweats	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	51M follow up, weight loss	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	54M follow up, fever	1 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	54M follow up, night sweats	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	54M follow up, weight loss	0 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	Withdrawal, extreme fatigue	9 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	Withdrawal, fever	7 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	Withdrawal, night sweats	14 Participants
Ofatumumab	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	Withdrawal, weight loss	4 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	36M follow up, extreme fatigue	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	36M follow up, weight loss	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	36M follow up, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C1 W2/M1, extreme fatigue	2 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	Withdrawal, extreme fatigue	12 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C1 W2/M1, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	39M follow up, weight loss	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C1 W2/M1, night sweats	6 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	9M follow up, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C2 W9/M3, fever	2 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C12 W89/M23, weight loss	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C2 W9/M3, night sweats	10 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	42M follow up, extreme fatigue	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C5 W33/M9, extreme fatigue	5 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	39M follow up, extreme fatigue	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	42M follow up, fever	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C6 W41/M11, weight loss	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	9M follow up, night sweats	2 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C7 W49/M13, extreme fatigue	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	42M follow up, night sweats	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C7 W49/M13, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	54M follow up, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C7 W49/M13, night sweats	5 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	42M follow up,, weight loss	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C8 W57/M15, extreme fatigue	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	9M follow up, weight loss	2 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C8 W57/M15, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	39M follow up, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C8 W57/M15, night sweats	4 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	SCR, extreme fatigue	7 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C8 W57/M15, weight loss	3 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	15M follow up, night sweats	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C13 W97/M25, extreme fatigue	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C9 W65/M17, extreme fatigue	2 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C13 W97/M25, night sweats	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	SCR, fever	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C9 W65/M17, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	SCR, night sweats	8 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C9 W65/M17, night sweats	4 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	18M follow up, extreme fatigue	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C9 W65/M17, weight loss	2 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	SCR, weight loss	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C10 W73/M19, extreme fatigue	2 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	Withdrawal, night sweats	15 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C10 W73/M19, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C1 W2/M1, weight loss	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C10 W73/M19, night sweats	4 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	39M follow up, night sweats	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C10 W73/M19, weight loss	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C2 W9/M3, extreme fatigue	3 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C11 W81/M21, extreme fatigue	3 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C11 W81/M21, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C2 W9/M3, weight loss	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C11 W81/M21, night sweats	4 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	18M follow up, weight loss	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C11 W81/M21, weight loss	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C3 W17/M5, extreme fatigue	5 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C12 W89/M23, extreme fatigue	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	54M follow up, night sweats	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C12 W89/M23, night sweats	3 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C3 W17/M5, fever	2 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	21M follow up, extreme fatigue	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C13 W97/M25, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C3 W17/M5, night sweats	10 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	51M follow up, extreme fatigue	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C13 W97/M25, weight loss	3 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C3 W17/M5, weight loss	3 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	3M follow up, extreme fatigue	2 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	21M follow up, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	3M follow up, fever	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C4 W25/M7, extreme fatigue (n=203, 187)	3 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	3M follow up, night sweats	4 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	Withdrawal, fever	3 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	3M follow up, weight loss	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	6M follow up, extreme fatigue	2 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C4 W25/M7, fever	2 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	6M follow up, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	21M follow up, night sweats	2 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	6M follow up, night sweats	2 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C4 W25/M7, night sweats	7 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	6M follow up, weight loss	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	30M follow up, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	9M follow up, extreme fatigue	2 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	12M follow up, extreme fatigue	3 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C4 W25/M7, weight loss	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	51M follow up, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	12M follow up, fever	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	27M follow up, extreme fatigue	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C5 W33/M9, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	12M follow up, night sweats	4 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	30M follow up, night sweats	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	12M follow up, weight loss	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C5 W33/M9, night sweats fatigue	8 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	15M follow up, extreme fatigue	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	54M follow up, weight loss	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	15M follow up, fever	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C5 W33/M9, weight loss	4 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	30M follow up, weight loss	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	15M follow up, weight loss	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C6 W41/M11, extreme fatigue	2 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	18M follow up, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	51M follow up, night sweats	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	18M follow up, night sweats	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C6 W41/M11, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	21M follow up, weight loss	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	33M follow up, extreme fatigue	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	27M follow up, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C6 W41/M11, night sweats	7 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	27M follow up, night sweats	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	Withdrawal, weight loss	10 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	27M follow up, weight loss	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C7 W49/M13, weight loss	1 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	30M follow up, extreme fatigue	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	51M follow up, weight loss	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	33M follow up, fever	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	36M follow up, night sweats	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	33M follow up, night sweats	2 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	54M follow up, extreme fatigue	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	33M follow up, weight loss	0 Participants
Observation	Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points	C12 W89/M23, fever	0 Participants

Secondary

Overall Survival

Overall survival is defined as time from randomization to date of death.

Time frame: From randomization until death (up to 88 months)

Population: ITT Population

Arm	Measure	Value (MEDIAN)
Ofatumumab	Overall Survival	NA Months
Observation	Overall Survival	73.63 Months

p-value: 0.604695% CI: [0.69, 1.25]Stratified log rank test

Secondary

Plasma Half-life (t1/2) of Ofatumumab

The terminal half life (t1/2) of ofatumumab is defined as the time required for the plasma concentration of ofatumumab to reach half of its original value.

Time frame: Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)

Population: PK Population. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Ofatumumab	Plasma Half-life (t1/2) of Ofatumumab	Cycle 1 Week 1	126 hours	Geometric Coefficient of Variation 35
Ofatumumab	Plasma Half-life (t1/2) of Ofatumumab	Cycle 1 Week 2	458 hours	Geometric Coefficient of Variation 36
Ofatumumab	Plasma Half-life (t1/2) of Ofatumumab	Cycle 4	542 hours	Geometric Coefficient of Variation 48

Secondary

Progression-free Survival After Next-line Therapy

Progression-free survival after next-line therapy is defined as the time from randomization until progression or death following the next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy and who did not have progression or death after next-line therapy were censored at their last date of contact. Participant who died prior to next-line therapy, was counted as an event.

Time frame: From randomization until progression or death (up to 88 months)

Population: ITT Population. Only participants who received next-line therapy and subjects who died prior to receiving next-line therapy were analyzed.

Arm	Measure	Value (MEDIAN)
Ofatumumab	Progression-free Survival After Next-line Therapy	NA Months
Observation	Progression-free Survival After Next-line Therapy	NA Months

p-value: 0.313695% CI: [0.42, 1.32]log rank test

Secondary

Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers

Blood samples were collected for the assessment of the following prognostic markers at Baseline (BL) and upon relapse: immunoglobulin heavy chain variable region (IgVH) mutational status; VH3-21 usage; Cytogenetics (by fluorescent in situ hybridization \[FISH\]) including 6q-, 11q-, +12q, 17p-, 13q- deletions; beta 2 microglobulin. Cox-regression model was used to explore the relationship between progression-free survival and the following explanatory variables: treatment group, cytogenetics (analyzed by FISH) at BL, IgVH mutational status at BL, beta 2 microglobulin at BL, BL CD20 and BL complement level. For each covariate, a hazard ratio \<1 indicates a lower risk on the first effect tested compared with the other effects tested. Cytogenetics Group (based on \>=20%)=CY G.

Time frame: From Baseline until the end of the study (up to 79 months)

Population: ITT Population

Arm	Measure	Group	Value (NUMBER)
Ofatumumab	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	CY G: 6q- or +12q or 13q	36 Participants
Ofatumumab	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	CY G: 17p-	7 Participants
Ofatumumab	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	CY G: 11q-	11 Participants
Ofatumumab	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	CY G: no aberration	166 Participants
Ofatumumab	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	CY G: missing	20 Participants
Ofatumumab	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	B2 Microglobulin G 2: > 3500 μg/L	80 Participants
Ofatumumab	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	B2 Microglobulin G 2: <=3500 μg/L	157 Participants
Ofatumumab	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	B2 Microglobulin G 2: missing	3 Participants
Ofatumumab	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	IgVH Mutational Status 1: mutated	54 Participants
Ofatumumab	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	IgVH Mutational Status 1: unmutated	139 Participants
Ofatumumab	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	IgVH Mutational Status 1: not available	3 Participants
Ofatumumab	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	IgVH Mutational Status 1: missing	44 Participants
Ofatumumab	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	VH3-21 Usage Flag: Yes	7 Participants
Ofatumumab	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	VH3-21 Usage Flag: No	233 Participants
Observation	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	IgVH Mutational Status 1: not available	1 Participants
Observation	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	CY G: 6q- or +12q or 13q	12 Participants
Observation	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	B2 Microglobulin G 2: missing	1 Participants
Observation	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	CY G: 17p-	4 Participants
Observation	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	VH3-21 Usage Flag: Yes	7 Participants
Observation	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	CY G: 11q-	10 Participants
Observation	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	IgVH Mutational Status 1: mutated	74 Participants
Observation	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	CY G: no aberration	181 Participants
Observation	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	IgVH Mutational Status 1: missing	49 Participants
Observation	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	CY G: missing	33 Participants
Observation	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	IgVH Mutational Status 1: unmutated	116 Participants
Observation	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	B2 Microglobulin G 2: > 3500 μg/L	68 Participants
Observation	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	VH3-21 Usage Flag: No	233 Participants
Observation	Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers	B2 Microglobulin G 2: <=3500 μg/L	171 Participants

95% CI: [1.051, 2.276]

95% CI: [4.934, 17.54]

95% CI: [2.468, 7.21]

95% CI: [1.434, 2.339]

95% CI: [0.432, 0.76]

95% CI: [0.692, 2.448]

Secondary

Time to Next Therapy

Time to next therapy is defined as the time from randomization to the date of receiving the next CLL treatment.

Time frame: From randomization until the end of the study (up to 88 months)

Population: ITT Population

Arm	Measure	Value (MEDIAN)
Ofatumumab	Time to Next Therapy	36.21 Months
Observation	Time to Next Therapy	27.56 Months

p-value: 0.017895% CI: [0.62, 0.96]Stratified log rank test

Secondary

Time to Progression After Next-line Therapy

Time to progression after next-line therapy is defined as the time from progression following randomization until progression or death following next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy with a PD prior to receiving next line therapy and who did not had progression or death after next-line therapy were censored at their last date of contact. If a participant died prior to next-line therapy, this was counted as an event.

Time frame: From randomization until progression or death (up to 88 months)

Population: ITT Population. Only participants who received next-line therapy and who also had PD prior to next line therapy were analysed. Participants who died prior to next-line therapy were also included for analysis.

Arm	Measure	Value (MEDIAN)
Ofatumumab	Time to Progression After Next-line Therapy	NA Months
Observation	Time to Progression After Next-line Therapy	NA Months

p-value: 0.160395% CI: [0.29, 1.19]log rank test

Secondary

Total Plasma Clearance (CL) of Ofatumumab

Plasma clearance is defined as the plasma volume that is cleared of drug per unit of time.

Time frame: Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)

Population: PK Population. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Ofatumumab	Total Plasma Clearance (CL) of Ofatumumab	Cycle 1 Week 1	49.1 millileters per hour (mL/hour)	Geometric Coefficient of Variation 38
Ofatumumab	Total Plasma Clearance (CL) of Ofatumumab	Cycle 1 Week 2	9.6 millileters per hour (mL/hour)	Geometric Coefficient of Variation 43
Ofatumumab	Total Plasma Clearance (CL) of Ofatumumab	Cycle 4	8.1 millileters per hour (mL/hour)	Geometric Coefficient of Variation 50

Secondary

Vss of Ofatumumab

Volume of distribution at steady state (Vss) is defined as the apparent volume of distribution of a drug between plasma and the rest of the body at steady state. Data from all time points collected were used to calculate one Vss value for each individual.

Time frame: Day 1 Month 1 ( Cycle 1) through Month 7 ( Cycle 4)

Population: PK Population. Only those participants available at the indicated time points were analyzed.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Ofatumumab	Vss of Ofatumumab	6.0 Liters (L)	Geometric Coefficient of Variation 27

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026

Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Progression-free Survival, as Assessed by the Independent Review Committee (IRC)

Progression-free Survival, as Assessed by the Investigator

AUC(0-tau) of Ofatumumab

Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)

Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points

Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score

Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale

Cmax and Ctrough of Ofatumumab

Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points

Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA)

Number of Participants Who Received at Least One Transfusion During the Study

Number of Participants Who Were Positive and Negative for Minimal Residual Disease (MRD) at Any Visit

Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points

Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)

Number of Participants With a Positive Anti-ofatumumab Antibody (Human Anti-human Antibody; HAHA) Result

Number of Participants With Grade 3 and Above Adverse Event of Infection

Number of Participants With Improvement in Response From Baseline

Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points

Overall Survival

Plasma Half-life (t1/2) of Ofatumumab

Progression-free Survival After Next-line Therapy

Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers

Time to Next Therapy

Time to Progression After Next-line Therapy

Total Plasma Clearance (CL) of Ofatumumab

Vss of Ofatumumab