Trial Outcomes & Findings for Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-α Antagonist Therapy (NCT NCT00603525)

NCT ID: NCT00603525

Last Updated: 2014-06-09

Results Overview

The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced \>=20% improvement from baseline in TJC and SJC and a \>=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 169 participants
• Primary outcome timeframe: Baseline and Week 24
• Results posted on: 2014-06-09

Participant Flow

Study OFA110634 is comprised of a 24-week Double-blind (DB) Period, followed by a 120-week Open-label (OL) Period. Participants who complete the OL Period, or who are withdrawn, enter a Follow-up (FU) period (anticipated to be approximately 2 years).

Participant milestones

Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks) in the DB Period.	Ofatumumab Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week \[oral, intramuscular, or subcutaneous\] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).	Placebo or OFA 700 mg: FU Period Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
DB Treatment Period (24 Weeks) STARTED	84	85	0
DB Treatment Period (24 Weeks) COMPLETED	67	63	0
DB Treatment Period (24 Weeks) NOT COMPLETED	17	22	0
OL Treatment Period (120 Weeks) STARTED	0	125	0
OL Treatment Period (120 Weeks) COMPLETED	0	13	0
OL Treatment Period (120 Weeks) NOT COMPLETED	0	112	0
Follow-up Period (Approximately 2 Years) STARTED	0	0	124
Follow-up Period (Approximately 2 Years) Unknown Reason for Withdrawal	0	0	111
Follow-up Period (Approximately 2 Years) COMPLETED	0	0	13
Follow-up Period (Approximately 2 Years) NOT COMPLETED	0	0	111

Reasons for withdrawal

Measure	Placebo Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks) in the DB Period.	Ofatumumab Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week \[oral, intramuscular, or subcutaneous\] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).	Placebo or OFA 700 mg: FU Period Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
DB Treatment Period (24 Weeks) Adverse Event	3	9	0
DB Treatment Period (24 Weeks) Lack of Efficacy	7	0	0
DB Treatment Period (24 Weeks) Protocol Violation	1	2	0
DB Treatment Period (24 Weeks) Lost to Follow-up	1	3	0
DB Treatment Period (24 Weeks) Withdrawal by Subject	5	6	0
DB Treatment Period (24 Weeks) Physician Decision	0	1	0
DB Treatment Period (24 Weeks) Participant Met Stopping Criteria	0	1	0
OL Treatment Period (120 Weeks) Adverse Event	0	12	0
OL Treatment Period (120 Weeks) Lack of Efficacy	0	13	0
OL Treatment Period (120 Weeks) Protocol Violation	0	1	0
OL Treatment Period (120 Weeks) Protocol-defined Stopping Criteria Met	0	5	0
OL Treatment Period (120 Weeks) Study Closed/Terminated	0	71	0
OL Treatment Period (120 Weeks) Physician Decision	0	2	0
OL Treatment Period (120 Weeks) Withdrawal by Subject	0	8	0
Follow-up Period (Approximately 2 Years) Unknown Reason for Withdrawal	0	0	111

Baseline Characteristics

Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-α Antagonist Therapy

Baseline characteristics by cohort

Measure	Placebo n=84 Participants Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Ofatumumab 700 mg n=85 Participants Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week \[oral, intramuscular, or subcutaneous\] for 24 weeks).	Total n=169 Participants Total of all reporting groups
Age, Continuous	53.3 Years STANDARD_DEVIATION 11.69 • n=5 Participants	53.7 Years STANDARD_DEVIATION 13.64 • n=7 Participants	53.5 Years STANDARD_DEVIATION 12.67 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	73 Participants n=7 Participants	140 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic/Latino	49 participants n=5 Participants	50 participants n=7 Participants	99 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Intent-to-Treat (ITT) Population: all randomized participants who were exposed to investigational product irrespective of their compliance to the planned course of treatment. Participants were analyzed according to their randomized treatment.

The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.

Outcome measures

Measure	Ofatumumab 700 mg n=85 Participants	Placebo or OFA 700 mg: FU Period	Placebo n=84 Participants
Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24	36 participants	—	16 participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, and 20

Population: ITT Population

The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.

Outcome measures

Measure	Ofatumumab 700 mg n=85 Participants	Placebo or OFA 700 mg: FU Period	Placebo n=84 Participants
Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20 Week 4	25 participants	—	22 participants
Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20 Week 8	29 participants	—	23 participants
Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20 Week 12	36 participants	—	30 participants
Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20 Week 16	36 participants	—	23 participants
Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20 Week 20	40 participants	—	21 participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population

The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR50 if he experienced >=50% improvement from baseline in TJC and SJC and a >=50% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.

Outcome measures

Measure	Ofatumumab 700 mg n=85 Participants	Placebo or OFA 700 mg: FU Period	Placebo n=84 Participants
Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24 Week 4	4 participants	—	9 participants
Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24 Week 8	9 participants	—	8 participants
Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24 Week 12	17 participants	—	11 participants
Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24 Week 16	17 participants	—	10 participants
Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24 Week 20	18 participants	—	8 participants
Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24 Week 24	19 participants	—	5 participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population

The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR70 if he experienced >=70% improvement from baseline in TJC and SJC and a >=70% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.

Outcome measures

Measure	Ofatumumab 700 mg n=85 Participants	Placebo or OFA 700 mg: FU Period	Placebo n=84 Participants
Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24 Week 4	0 participants	—	3 participants
Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24 Week 8	3 participants	—	2 participants
Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24 Week 12	5 participants	—	3 participants
Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24 Week 16	5 participants	—	3 participants
Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24 Week 20	5 participants	—	3 participants
Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24 Week 24	6 participants	—	3 participants

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population. Only those participants contributing values at the relevant visit were analyzed.

The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.

Outcome measures

Measure	Ofatumumab 700 mg n=73 Participants	Placebo or OFA 700 mg: FU Period	Placebo n=80 Participants
Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR) Week 4, n=80, 73	5.02 scores on a scale Standard Deviation 1.361	—	5.00 scores on a scale Standard Deviation 1.492
Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR) Week 8, n=74, 73	4.60 scores on a scale Standard Deviation 1.300	—	4.96 scores on a scale Standard Deviation 1.352
Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR) Week 12, n=73, 71	4.16 scores on a scale Standard Deviation 1.194	—	4.86 scores on a scale Standard Deviation 1.537
Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR) Week 16, n=69, 71	4.17 scores on a scale Standard Deviation 1.273	—	4.88 scores on a scale Standard Deviation 1.526
Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR) Week 20, n=67, 68	4.04 scores on a scale Standard Deviation 1.262	—	4.91 scores on a scale Standard Deviation 1.505
Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR) Week 24, n=68, 67	4.22 scores on a scale Standard Deviation 1.432	—	5.21 scores on a scale Standard Deviation 1.324

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.

The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints, the APR, and general health (patient global assessment). The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation. Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.

Outcome measures

Measure	Ofatumumab 700 mg n=73 Participants	Placebo or OFA 700 mg: FU Period	Placebo n=80 Participants
Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 4, n=80, 73	-0.89 scores on a scale Standard Deviation 1.094	—	-0.83 scores on a scale Standard Deviation 1.237
Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 8, n=74, 73	-1.22 scores on a scale Standard Deviation 1.142	—	-0.81 scores on a scale Standard Deviation 1.127
Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 12, n=73, 71	-1.64 scores on a scale Standard Deviation 1.242	—	-0.92 scores on a scale Standard Deviation 1.382
Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 16, n=69, 71	-1.64 scores on a scale Standard Deviation 1.318	—	-0.86 scores on a scale Standard Deviation 1.362
Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 20, n=67, 68	-1.75 scores on a scale Standard Deviation 1.311	—	-0.79 scores on a scale Standard Deviation 1.270
Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 24, n=68, 67	-1.56 scores on a scale Standard Deviation 1.370	—	-0.51 scores on a scale Standard Deviation 1.142

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population. Only those participants contributing values at the relevant visit were analyzed.

The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.

Outcome measures

Measure	Ofatumumab 700 mg n=74 Participants	Placebo or OFA 700 mg: FU Period	Placebo n=80 Participants
Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant (ARP) Week 4, n=80, 74	5.80 scores on a scale Standard Deviation 1.390	—	5.84 scores on a scale Standard Deviation 1.455
Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant (ARP) Week 8, n=74, 72	5.41 scores on a scale Standard Deviation 1.335	—	5.76 scores on a scale Standard Deviation 1.327
Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant (ARP) Week 12, n=73, 71	4.99 scores on a scale Standard Deviation 1.269	—	5.60 scores on a scale Standard Deviation 1.498
Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant (ARP) Week 16, n=69, 71	4.95 scores on a scale Standard Deviation 1.356	—	5.66 scores on a scale Standard Deviation 1.481
Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant (ARP) Week 20, n=67, 68	4.79 scores on a scale Standard Deviation 1.312	—	5.74 scores on a scale Standard Deviation 1.539
Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant (ARP) Week 24, n=68, 67	5.03 scores on a scale Standard Deviation 1.537	—	5.96 scores on a scale Standard Deviation 1.358

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.

The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints, the APR, and general health (patient global assessment). The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation. Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.

Outcome measures

Measure	Ofatumumab 700 mg n=74 Participants	Placebo or OFA 700 mg: FU Period	Placebo n=80 Participants
Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 4, n=80, 74	-0.98 scores on a scale Standard Deviation 1.105	—	-0.85 scores on a scale Standard Deviation 1.210
Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 8, n=74, 72	-1.28 scores on a scale Standard Deviation 1.165	—	-0.88 scores on a scale Standard Deviation 1.117
Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 12, n=73, 71	-1.70 scores on a scale Standard Deviation 1.304	—	-1.05 scores on a scale Standard Deviation 1.332
Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 16, n=69, 71	-1.75 scores on a scale Standard Deviation 1.350	—	-0.95 scores on a scale Standard Deviation 1.353
Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 20, n=67, 68	-1.89 scores on a scale Standard Deviation 1.299	—	-0.85 scores on a scale Standard Deviation 1.299
Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 24, n=68, 67	-1.64 scores on a scale Standard Deviation 1.473	—	-0.63 scores on a scale Standard Deviation 1.211

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population

The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.

Outcome measures

Measure	Ofatumumab 700 mg n=85 Participants	Placebo or OFA 700 mg: FU Period	Placebo n=84 Participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 4, Good	8 participants	—	15 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 4, Moderate	25 participants	—	18 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 4, None	40 participants	—	47 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 8, Good	11 participants	—	11 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 8, Moderate	31 participants	—	23 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 8, None	31 participants	—	40 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 12, Good	14 participants	—	13 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 12, Moderate	39 participants	—	22 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 12, None	18 participants	—	38 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 16, Good	17 participants	—	9 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 16, Moderate	33 participants	—	23 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 16, None	21 participants	—	37 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 20, Good	18 participants	—	10 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 20, Moderate	32 participants	—	21 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 20, None	18 participants	—	36 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 24, Good	15 participants	—	6 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 24, Moderate	29 participants	—	19 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant Week 24, None	23 participants	—	43 participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population

The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.

Outcome measures

Measure	Ofatumumab 700 mg n=85 Participants	Placebo or OFA 700 mg: FU Period	Placebo n=84 Participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 4, Good	4 participants	—	3 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 4, Moderate	21 participants	—	29 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 4, None	49 participants	—	48 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 8, Good	5 participants	—	2 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 8, Moderate	33 participants	—	28 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 8, None	34 participants	—	44 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 12, Good	7 participants	—	2 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 12, Moderate	41 participants	—	36 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 12, None	23 participants	—	35 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 16, Good	6 participants	—	3 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 16, Moderate	43 participants	—	29 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 16, None	22 participants	—	37 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 20, Good	5 participants	—	1 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 20, Moderate	46 participants	—	27 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 20, None	17 participants	—	39 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 24, Good	6 participants	—	2 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 24, Moderate	37 participants	—	20 participants
Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant Week 24, None	24 participants	—	46 participants

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.

ACRn = the largest integer n for which a participant (par.) met the criteria requiring an improvement of n%. ACRn is a measure characterizing percentage (%) improvement from baseline (IFBL). A par. with an ACRn of X had an improvement of >=X% in tender/swollen joints (TJC/SJC), and an improvement of >=X% in 3 of the 5 parameters (patient [pt] pain assessment, pt global assessment [GA], physician GA, pt self-assessed disability, acute phase reactant). ACRn = min(TJC % IFBL, SJC % IFBL, composite measure % IFBL). Composite measure % IFBL is the 3rd highest value of % IFBL for the 5 parameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, and 24

Population: ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.

The HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Responders were defined as participants achieving an improvement from baseline in the HAQ-DI score at Week 24 of >=0.22.

Outcome measures

Measure	Ofatumumab 700 mg n=72 Participants	Placebo or OFA 700 mg: FU Period	Placebo n=75 Participants
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 4, 8, 12, 16, 20, and 24 Week 4, n=75, 72	-0.13 scores on a scale Interval -1.9 to 1.4	—	-0.13 scores on a scale Interval -1.9 to 0.8
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 4, 8, 12, 16, 20, and 24 Week 8, n=69, 68	-0.38 scores on a scale Interval -1.6 to 0.9	—	-0.25 scores on a scale Interval -2.1 to 1.1
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 4, 8, 12, 16, 20, and 24 Week 12, n=68, 65	-0.38 scores on a scale Interval -1.9 to 1.0	—	-0.13 scores on a scale Interval -2.3 to 1.0
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 4, 8, 12, 16, 20, and 24 Week 16, n=65, 64	-0.38 scores on a scale Interval -2.0 to 0.5	—	-0.13 scores on a scale Interval -2.1 to 1.0
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 4, 8, 12, 16, 20, and 24 Week 20, n=64, 64	-0.38 scores on a scale Interval -2.1 to 1.3	—	-0.13 scores on a scale Interval -2.3 to 1.1
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 4, 8, 12, 16, 20, and 24 Week 24, n=63, 61	-0.38 scores on a scale Interval -2.1 to 1.5	—	0.00 scores on a scale Interval -2.3 to 1.0

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.

Change from baseline in tender joint count was calculated as the Week 24 count minus the baseline count. A total of 68 joints were assessed. Joints were classified as either tender or not tender by an independent assessor, who had documented experience in performing joint assessments.

Outcome measures

Measure	Ofatumumab 700 mg n=66 Participants	Placebo or OFA 700 mg: FU Period	Placebo n=68 Participants
Change From Baseline in Tender Joint Count at Week 24	-11 tender joints Interval -56.0 to 14.0	—	-5 tender joints Interval -46.0 to 23.0

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.

Change from baseline in swollen joint count was calculated as the Week 24 count minus the baseline count. A total of 66 joints were assessed. Joints were classified as either swollen or not swollen by an independent assessor, who had documented experience in performing joint assessments.

Outcome measures

Measure	Ofatumumab 700 mg n=66 Participants	Placebo or OFA 700 mg: FU Period	Placebo n=68 Participants
Change From Baseline in Swollen Joint Count at Week 24	-7.50 swollen joints Interval -27.0 to 33.0	—	-3.50 swollen joints Interval -27.0 to 37.0

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.

Blood samples for the determination of CRP were taken at pre-specified visits and were sent to the central laboratory for analysis. Change from baseline in CRP was calculated as the Week 24 value minus the baseline value. CRP is an acute-phase protein whose plasma concentration increases in response to inflammation. CRP is a useful marker of inflammation.

Outcome measures

Measure	Ofatumumab 700 mg n=66 Participants	Placebo or OFA 700 mg: FU Period	Placebo n=66 Participants
Change From Baseline in CRP at Week 24	-2.85 milligrams per liter (mg/L) Interval -150.6 to 41.4	—	1.05 milligrams per liter (mg/L) Interval -51.5 to 94.0

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.

ESR is measured by a blood test that shows the rate at which red blood cells sediment in a period of 1 hour. Blood samples for the determination of ESR were taken at pre-specified visits and were measured immediately at the trial site. Change from baseline in ESR was calculated as the Week 24 value minus the baseline value.

Outcome measures

Measure	Ofatumumab 700 mg n=67 Participants	Placebo or OFA 700 mg: FU Period	Placebo n=67 Participants
Change From Baseline in ESR at Week 24	-12.00 millimeters per hour (mm/hr) Interval -100.0 to 45.0	—	0.00 millimeters per hour (mm/hr) Interval -73.0 to 52.0

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.

A horizontal VAS of 100 mm was used to report the participant's level of joint pain. The scale ranged from 0 (no pain) to 100 (unbearable pain). Participants were instructed to draw a vertical line through the horizontal line to indicate how much joint pain they had. The distance from the "no pain" end to the vertical line drawn by the participant was the joint pain score. Change from baseline was calculated as the Week 24 value minus the baseline value.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.

The participant used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Participants were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the "very well" end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in participant-assessed global disease was calculated as the Week 24 value minus the baseline value.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.

The physician used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Physicians were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the "very well" end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in the physician-assessed global disease was calculated as the Week 24 value minus the baseline value.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.

The FACIT-F score has a valid range of values from 0 to 52, with a higher score indicating a lower burden of fatigue. The subset determining fatigue contains 13 questions. Responses to each question were scored from 0, indicating "Not at all fatigued," to 4, indicating "Very much fatigued."

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.

The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.

The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and MH summary measures and a preference-based health utility index.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: ITT Population. Only those participants contributing values at the relevant visit were analyzed.

The following biomarkers were assessed: Anti-Cyclic Citrullinated Peptide 3 antibody (Anti-CCP), Rheumatoid factor IgA (RF-IgA), RF IgG (RF-IgG), and RF IgM (RF-IgM). Measurements of RF were used to characterize participants' disease activity and immune status. Anti-CCP was used to characterize the disease type and the immune status of the participants. Assessments for which results were below the lower limit of quantification (LLQ) were reported using a value of LLQ/2. Assessments for which results were above the upper limit of quantification (ULQ) were reported using a value of ULQ.

Outcome measures

Measure	Ofatumumab 700 mg n=82 Participants	Placebo or OFA 700 mg: FU Period	Placebo n=81 Participants
Biomarker Levels for Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Baseline and Week 4 Anti-CCP, Baseline, n=81, 82	449.5 Units/Liter Interval 8.0 to 8261.0	—	466 Units/Liter Interval 8.0 to 10828.0
Biomarker Levels for Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Baseline and Week 4 RF-IgA, Baseline, n=81, 81	11 Units/Liter Interval 2.5 to 100.0	—	9 Units/Liter Interval 2.5 to 100.0
Biomarker Levels for Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Baseline and Week 4 RF-IgA, Week 4, n=0, 1	100 Units/Liter Interval 100.0 to 100.0	—	NA Units/Liter No participants were analyzed at this time point.
Biomarker Levels for Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Baseline and Week 4 IgG, Baseline, n=81, 81	2.5 Units/Liter Interval 2.5 to 100.0	—	5 Units/Liter Interval 2.5 to 100.0
Biomarker Levels for Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Baseline and Week 4 IgG, Week4, n=0, 1	5 Units/Liter Interval 5.0 to 5.0	—	NA Units/Liter No participants were analyzed at this time point.
Biomarker Levels for Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Baseline and Week 4 RF-IgM, Baseline, n=81, 81	68 Units/Liter Interval 2.5 to 100.0	—	92 Units/Liter Interval 2.5 to 100.0
Biomarker Levels for Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Baseline and Week 4 RF-IgM, Week 4, n=0, 1	43 Units/Liter Interval 43.0 to 43.0	—	NA Units/Liter No participants were analyzed at this time point.

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.

Detection of human anti-human antibodies (HAHAs) against ofatumumab was to be performed by Electrochemiluminescent (ECL) Meso-Scale Discovery (MSD) immunoassay. Positive samples from the binding antibody test were also tested in a neutralizing antibody assay.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 12, and Week 24

Population: Safety Population: identical to the ITT population except that participants were analyzed according to their actual treatment when this differed from their randomized treatment. Only those participants contributing values at baseline and the relevant visit were analzyed.

The following immunoglobulins were assessed: IgA, IgG and IgM. 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.

Outcome measures

Measure	Ofatumumab 700 mg n=75 Participants	Placebo or OFA 700 mg: FU Period	Placebo n=79 Participants
Change From Baseline in Levels of IgA, IgG and IgM at Week 12 and Week 24 IgA, Week 12; n=79, 75	-0.250 grams per Liter (g/L) Interval -2.32 to 0.65	—	-0.020 grams per Liter (g/L) Interval -1.72 to 1.47
Change From Baseline in Levels of IgA, IgG and IgM at Week 12 and Week 24 IgA, Week 24; n=69, 68	-0.350 grams per Liter (g/L) Interval -2.58 to 0.81	—	0.050 grams per Liter (g/L) Interval -1.51 to 1.47
Change From Baseline in Levels of IgA, IgG and IgM at Week 12 and Week 24 IgG, Week 12; n=79, 75	-1.300 grams per Liter (g/L) Interval -7.6 to 2.1	—	-0.400 grams per Liter (g/L) Interval -7.3 to 7.2
Change From Baseline in Levels of IgA, IgG and IgM at Week 12 and Week 24 IgG, Week 24; n=69, 68	-1.615 grams per Liter (g/L) Interval -9.7 to 4.8	—	-0.700 grams per Liter (g/L) Interval -8.3 to 8.3
Change From Baseline in Levels of IgA, IgG and IgM at Week 12 and Week 24 IgM, Week 12; n=79, 75	-0.260 grams per Liter (g/L) Interval -2.92 to 0.17	—	-0.040 grams per Liter (g/L) Interval -1.58 to 0.75
Change From Baseline in Levels of IgA, IgG and IgM at Week 12 and Week 24 IgM, Week 24; n=69, 68	-0.355 grams per Liter (g/L) Interval -4.12 to 0.4	—	-0.050 grams per Liter (g/L) Interval -1.3 to 1.47

SECONDARY outcome

Timeframe: First 24 weeks of each treatment course (assessed up to Week 144)

Population: As Treated (AT) Population: all participants who received at least one infusion of ofatumumab in the DB and/or OL Period

The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course (TC), assessed using erythrocyte sedimentation rate (ESR; rate at which red blood cells sediment in 1 hour).

Outcome measures

Measure	Ofatumumab 700 mg n=148 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Minimum DAS28-ESR Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, n=0, 148, 0	4.64 Scores on a scale Standard Deviation 1.511	—	—
Minimum DAS28-ESR Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, n=0, 92, 0	4.08 Scores on a scale Standard Deviation 1.129	—	—
Minimum DAS28-ESR Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, n=0, 62, 0	4.09 Scores on a scale Standard Deviation 1.346	—	—
Minimum DAS28-ESR Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, n=0, 29, 0	3.84 Scores on a scale Standard Deviation 1.437	—	—
Minimum DAS28-ESR Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, n=0, 13, 0	3.95 Scores on a scale Standard Deviation 1.327	—	—
Minimum DAS28-ESR Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, n=0, 6, 0	3.33 Scores on a scale Standard Deviation 1.245	—	—

SECONDARY outcome

Timeframe: First 24 weeks of each treatment course (assessed up to Week 144)

Population: AT Population

The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course, assessed using C-reactive Protein (CRP: used to monitor acute inflammatory phases of rheumatoid arthritis).

Outcome measures

Measure	Ofatumumab 700 mg n=147 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, n=0, 147, 0	3.86 scores on a scale Standard Deviation 1.443	—	—
Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, n=0, 92, 0	3.37 scores on a scale Standard Deviation 1.120	—	—
Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, n=0, 62, 0	3.35 scores on a scale Standard Deviation 1.181	—	—
Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, n=0, 29, 0	3.15 scores on a scale Standard Deviation 1.214	—	—
Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, n=0, 13, 0	3.23 scores on a scale Standard Deviation 1.129	—	—
Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, n=0, 6, 0	2.84 scores on a scale Standard Deviation 1.193	—	—

SECONDARY outcome

Timeframe: First 24 weeks of each treatment course (assessed up to Week 144)

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using ESR. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.

Outcome measures

Measure	Ofatumumab 700 mg n=134 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Minimum Change From Baseline DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, n=0, 134, 0	-2.04 scores on a scale Standard Deviation 1.348	—	—
Minimum Change From Baseline DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, n=0, 90, 0	-1.70 scores on a scale Standard Deviation 1.090	—	—
Minimum Change From Baseline DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, n=0, 59, 0	-1.52 scores on a scale Standard Deviation 1.052	—	—
Minimum Change From Baseline DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, n=0, 28, 0	-1.76 scores on a scale Standard Deviation 1.499	—	—
Minimum Change From Baseline DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, n=0, 12, 0	-1.50 scores on a scale Standard Deviation 1.052	—	—
Minimum Change From Baseline DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, n=0, 6, 0	-2.39 scores on a scale Standard Deviation 0.581	—	—

SECONDARY outcome

Timeframe: First 24 weeks of each treatment course (assessed up to Week 144)

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using CRP. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.

Outcome measures

Measure	Ofatumumab 700 mg n=134 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Minimum Change From Baseline DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, n=0, 134, 0	-1.93 scores on a scale Standard Deviation 1.297	—	—
Minimum Change From Baseline DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, n=0, 92, 0	-1.65 scores on a scale Standard Deviation 1.086	—	—
Minimum Change From Baseline DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, n=0, 61, 0	-1.44 scores on a scale Standard Deviation 1.006	—	—
Minimum Change From Baseline DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, n=0, 28, 0	-1.65 scores on a scale Standard Deviation 1.378	—	—
Minimum Change From Baseline DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, n=0, 12, 0	-1.46 scores on a scale Standard Deviation 1.006	—	—
Minimum Change From Baseline DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, n=0, 6, 0	-2.20 scores on a scale Standard Deviation 0.610	—	—

SECONDARY outcome

Timeframe: From Baseline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Time to retreatment is defined as the time in days between infusion A of each treatment course and infusion A of the following treatment course. For participants randomized to ofatumumab in the Double-blind Period, Treatment Course 1 refers to the course of ofatumumab received in the Double-blind Period. The minimum period allowed per protocol before retreatment was 24 weeks (end of Double-blind Period). For participants randomized to placebo in the Double-blind Period, Treatment Course 1 refers to the first course of ofatumumab received in the Open-label Period. The minimum period allowed per protocol before retreatment during the Open-label Period was 16 weeks.

Outcome measures

Measure	Ofatumumab 700 mg n=93 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Time to Retreatment, by Ofatumumab Treatment Course TC 1, n=0, 93, 0	32.79 Days Standard Deviation 12.031	—	—
Time to Retreatment, by Ofatumumab Treatment Course TC 2, n=0, 63, 0	28.62 Days Standard Deviation 11.108	—	—
Time to Retreatment, by Ofatumumab Treatment Course TC 3, n=0, 30, 0	24.56 Days Standard Deviation 8.127	—	—
Time to Retreatment, by Ofatumumab Treatment Course TC 4, n=0, 13, 0	23.93 Days Standard Deviation 6.143	—	—
Time to Retreatment, by Ofatumumab Treatment Course TC 5, n=0, 6, 0	19.07 Days Standard Deviation 2.795	—	—
Time to Retreatment, by Ofatumumab Treatment Course TC 6, n=0, 0, 0	NA Days Standard Deviation NA No participants were analyzed in this treatment group for Treatment Course 6.	—	—

SECONDARY outcome

Timeframe: First 24 weeks of each treatment course (assessed up to Week 144)

Population: AT Population

The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.

Outcome measures

Measure	Ofatumumab 700 mg n=148 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Remission, n=0, 148, 0	15 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Low Disease Activity, n=0, 148	7 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Remission, n=0, 93, 0	5 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Low Disease Activity, n=0, 93, 0	20 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Remission, n=0, 63, 0	8 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Low Disease Activity, n=0, 63, 0	8 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Remission, n=0, 30, 0	6 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Low Disease Activity, n=0, 30, 0	5 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Remission, n=0, 13, 0	2 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Low Disease Activity, n=0, 13, 0	2 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Remission, n=0, 6, 0	2 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Low Disease Activity, n=0, 6, 0	2 participants	—	—

SECONDARY outcome

Timeframe: First 24 weeks of each treatment course (assessed up to Week 144)

Population: AT Population

The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.

Outcome measures

Measure	Ofatumumab 700 mg n=148 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Remission, n=0, 148, 0	27 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Low Disease Activity, n=0, 148, 0	26 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Remission, n=0, 93, 0	24 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Low Disease Activity, n=0, 93, 0	17 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Remission, n=0, 63, 0	19 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Low Disease Activity, n=0, 63, 0	10 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Remission, n=0, 30, 0	10 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Low Disease Activity, n=0, 30, 0	5 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Remission,n=0, 13, 0	5 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Low Disease Activity,n=0, 13, 0	1 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Remission,n=0, 6, 0	3 participants	—	—
Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Low Disease Activity,n=0, 6, 0	2 participants	—	—

SECONDARY outcome

Timeframe: First treatment (Day 0) until the participant terminated the trial, assessed up to Week 144

Population: AT Population

An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (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; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=2%) and SAEs.

Outcome measures

Measure	Ofatumumab 700 mg n=148 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any AE, TC 1, n=0, 148, 0	126 Participants	—	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any AE, TC 2, n=0, 93, 0	60 Participants	—	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any AE, TC 3, n=0, 63, 0	36 Participants	—	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any AE, TC 4, n=0, 30, 0	17 Participants	—	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any AE, TC 5, n=0, 13, 0	8 Participants	—	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any AE, TC 6, n=0, 6, 0	5 Participants	—	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any SAE, TC 1, n=0, 148, 0	20 Participants	—	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any SAE, TC 2, n=0, 93, 0	10 Participants	—	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any SAE, TC 3, n=0, 63, 0	2 Participants	—	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any SAE, TC 4, n=0, 30, 0	0 Participants	—	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any SAE, TC 5, n=0, 13, 0	0 Participants	—	—
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course Any SAE, TC 6, n=0, 6, 0	0 Participants	—	—

SECONDARY outcome

Timeframe: From DB Period completion (Week 24) until the completion of the OL Period, assessed up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), during the OL Period are presented. An overall interpretation of the ECG was made by the investigator, or the investigator could delegate this task to a cardiologist, if applicable.

Outcome measures

Measure	Ofatumumab 700 mg n=117 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 48, normal, n=0, 117, 0	81 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 48, abnormal CS, n=0, 117, 0	0 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 48, abnormal NCS, n=0, 117, 0	34 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 48, NR, n=0, 117, 0	2 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 72, normal, n=0, 87, 0	59 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 72, abnormal CS, n=0, 87, 0	0 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 72, abnormal NCS, n=0, 87, 0	25 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 72, NR, n=0, 87, 0	3 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 96, normal, n=0, 57, 0	40 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 96, abnormal CS, n=0, 57, 0	0 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 96, abnormal NCS, n=0, 57, 0	16 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 96, NR, n=0, 57, 0	1 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 120, normal, n=0, 33, 0	16 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 120, abnormal CS, n=0, 33, 0	0 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 120, abnormal NCS, n=0, 33, 0	17 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 120, NR, n=0, 33, 0	0 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 144, normal, n=0, 17, 0	10 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 144, abnormal CS, n=0, 17, 0	0 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 144, abnormal NCS, n=0, 17, 0	7 Participants	—	—
Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period Week 144, NR, n=0, 17, 0	0 Participants	—	—

SECONDARY outcome

Timeframe: From baseline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

The number of participants with a CD19+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.

Outcome measures

Measure	Ofatumumab 700 mg n=136 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 8, n=0, 136, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 16, n=0, 100, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 24, n=0, 99, 0	2 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 32, n=0, 50, 0	1 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 40, n=0, 30, 0	3 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 48, n=0, 23, 0	1 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 56, n=0, 14, 0	3 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 64, n=0, 7, 0	1 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 72, n=0, 4, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 80, n=0, 1, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 88, n=0, 1, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 96, n=0, 1, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 104, n=0, 2, 0	1 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 112, n=0, 1, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 120, n=0, 1, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 128, n=0, 1, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 144, n=0, 1, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 8, n=0, 93, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 16, n=0, 80, 0	1 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 24, n=0, 70, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 32, n=0, 31, 0	2 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 40, n=0, 20, 0	2 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 48, n=0, 11, 0	1 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 56, n=0, 8, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 64, n=0, 6, 0	1 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 72, n=0, 2, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 80, n=0, 2, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 96, n=0, 1, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 8, n=0, 60, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 16, n=0, 45, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 24, n=0, 29, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 32, n=0, 12, 0	1 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 40, n=0, 4, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 48, n=0, 2, 0	1 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 56, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 8, n=0, 29, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 16, n=0, 24, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 24, n=0, 13, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 32, n=0, 4, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 40, n=0, 1, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 48, n=0, 1, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 8, n=0, 13, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 16, n=0, 8, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 24, n=0, 5, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 32, n=0, 5, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 40, n=0, 1, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 8, n=0, 6, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 16, n=0, 6, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 24, n=0, 5, 0	0 Participants	—	—
Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 32, n=0, 3, 0	0 Participants	—	—

SECONDARY outcome

Timeframe: From baseline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

The number of participants with a CD3+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.

Outcome measures

Measure	Ofatumumab 700 mg n=136 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 120, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 128, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 144, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 8, n=0, 93, 0	78 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 16, n=0, 80, 0	70 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 24, n=0, 70, 0	58 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 32, n=0, 31, 0	29 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 40, n=0, 20, 0	16 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 48, n=0, 11, 0	9 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 56, n=0, 8, 0	7 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 64, n=0, 6, 0	4 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 72, n=0, 2, 0	2 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 80, n=0, 2, 0	2 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 96, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 8, n=0, 60, 0	49 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 16, n=0, 45, 0	36 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 24, n=0, 29, 0	22 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 32, n=0, 12, 0	10 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 40, n=0, 4, 0	2 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 48, n=0, 2, 0	1 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 56, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 8, n=0, 29, 0	24 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 16, n=0, 24, 0	20 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 24, n=0, 13, 0	11 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 32, n=0, 4, 0	3 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 40, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 48, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 8, n=0, 13, 0	10 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 16, n=0, 8, 0	7 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 24, n=0, 5, 0	4 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 32, n=0, 5, 0	4 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 40, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 8, n=0, 6, 0	5 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 16, n=0, 6, 0	5 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 24, n=0, 5, 0	5 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 32, n=0, 3, 0	3 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 8, n=0, 136, 0	115 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 16, n=0, 100, 0	79 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 24, n=0, 99, 0	75 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 32, n=0, 50, 0	44 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 40, n=0, 30, 0	27 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 48, n=0, 23, 0	21 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 56, n=0, 14, 0	11 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 64, n=0, 7, 0	7 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 72, n=0, 4, 0	4 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 80, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 88, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 96, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 104, n=0, 2, 0	2 Participants	—	—
Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 112, n=0, 1, 0	1 Participants	—	—

SECONDARY outcome

Timeframe: From baseline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

The number of participants with a CD4+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.

Outcome measures

Measure	Ofatumumab 700 mg n=136 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 8, n=0, 136, 0	118 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 16, n=0, 100, 0	83 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 24, n=0, 99, 0	80 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 32, n=0, 50, 0	45 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 40, n=0, 30, 0	27 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 48, n=0, 23, 0	21 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 56, n=0, 14, 0	13 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 64, n=0, 7, 0	7 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 72, n=0, 4, 0	4 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 80, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 88, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 96, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 104, n=0, 2, 0	2 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 112, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 120, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 128, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 144, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 8, n=0, 93, 0	81 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 16, n=0, 80, 0	67 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 24, n=0, 70, 0	62 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 32, n=0, 31, 0	29 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 40, n=0, 20, 0	16 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 48, n=0, 11, 0	9 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 56, n=0, 8, 0	7 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 64, n=0, 6, 0	4 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 72, n=0, 2, 0	2 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 80, n=0, 2, 0	2 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 96, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 8, n=0, 60, 0	49 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 16, n=0, 45, 0	36 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 24, n=0, 29, 0	23 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 32, n=0, 12, 0	11 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 40, n=0, 4, 0	3 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 48, n=0, 2, 0	2 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 56, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 8, n=0, 29, 0	26 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 16, n=0, 24, 0	20 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 24, n=0, 13, 0	11 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 32, n=0, 4, 0	3 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 40, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 48, n=0, 1	1 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 8, n=0, 13, 0	12 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 16, n=0, 8, 0	8 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 24, n=0, 5, 0	5 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 32, n=0, 5, 0	5 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 40, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 8, n=0, 6, 0	5 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 16, n=0, 6, 0	6 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 24, n=0, 5, 0	5 Participants	—	—
Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 32, n=0, 3, 0	3 Participants	—	—

SECONDARY outcome

Timeframe: From baseline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

The number of participants with a CD8+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.

Outcome measures

Measure	Ofatumumab 700 mg n=136 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 8, n=0, 136, 0	121 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 16, n=0, 100, 0	86 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 24, n=0, 99, 0	87 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 32, n=0, 50, 0	47 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 40, n=0, 30, 0	27 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 48, n=0, 23, 0	20 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 56, n=0, 14, 0	13 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 64, n=0, 7, 0	7 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 72, n=0, 4, 0	4 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 80, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 88, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 96, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 104, n=0, 2, 0	2 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 112, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 120, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 128, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 1, Week 144, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 8, n=0, 93, 0	82 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 16, n=0, 80, 0	74 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 24, n=0, 70, 0	63 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 32, n=0, 31, 0	29 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 40, n=0, 20, 0	19 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 48, n=0, 11, 0	11 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 56, n=0, 8, 0	7 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 64, n=0, 6, 0	5 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 72, n=0, 2, 0	2 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 80, n=0, 2, 0	2 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 2, Week 96, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 8, n=0, 60, 0	54 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 16, n=0, 45, 0	43 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 24, n=0, 29, 0	24 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 32, n=0, 12, 0	12 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 40, n=0, 4, 0	3 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 48, n=0, 2, 0	1 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 3, Week 56, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 8, n=0, 29, 0	26 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 16, n=0, 24, 0	23 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 24, n=0, 13, 0	13 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 32, n=0, 4, 0	4 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 40, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 4, Week 48, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 8, n=0, 13, 0	13 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 16, n=0, 8, 0	8 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 24, n=0, 5, 0	5 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 32, n=0, 5, 0	5 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 5, Week 40, n=0, 1, 0	1 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 8, n=0, 6, 0	5 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 16, n=0, 6, 0	5 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 24, n=0, 5, 0	5 Participants	—	—
Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course TC 6, Week 32, n=0, 3, 0	2 Participants	—	—

SECONDARY outcome

Timeframe: From baseline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: Albumin: 0.9, 1.5; Alanine amino transferase (ALT): NA, 2; Alkaline phosphatase (ALP): NA, 1.5; Aspartate amino transferase (AST): NA, 2; Bilirubin total (TBIL): NA, 1.5; Calcium: 0.85, 1.08; CO2 content/bicarbonate (BCO): 0.85, 1.2; Creatine kinase (CK): NA, 2; Creatinine: NA, 1.2; Gamma glutamyl transferase (GGT): NA, 2; Potassium: 0.9, 1.1; Urea/blood urea nitrogen (BUN): NA, 1.5; Uric acid: NA, 1.5.

Outcome measures

Measure	Ofatumumab 700 mg n=144 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 1, BL, CC low, n=0, 144, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 1, PBL, CC low, n=0, 136, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 1, BL, CC high, n=0, 144, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 1, PBL, CC high, n=0, 136, 0	6 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 1, BL, CC high, n=0, 144, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 1, PBL, CC high, n=0, 136, 0	4 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 1, BL, CC high, n=0, 142, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 1, PBL, CC high, n=0, 136, 0	2 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 1, BL, CC high, n=0, 144, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 1, PBL, CC high, n=0, 136, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 1, BL, CC low, n=0, 142, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 1, PBL, CC low, n=0, 136, 0	2 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 1, BL, CC high, n=0, 142, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 1, PBL, CC high, n=0, 136, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 1, BL, CC low, n=0, 142, 0	5 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 1, PBL, CC low, n=0, 136, 0	9 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 1, BL, CC high, n=0, 144, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 1, PBL, CC high, n=0, 136, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 1, BL, CC high, n=0, 144, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 1,PBL, CC high, n=0, 136, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 1, BL, CC high, n=0, 144, 0	7 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 1, PBL, CC high, n=0, 136, 0	8 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 1, BL, CC high, n=0, 142, 0	2 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 1, PBL, CC high, n=0, 136, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 1, BL, CC low, n=0, 142, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 1, PBL, CC low, n=0, 136, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 1, BL, CC high, n=0, 144, 0	2 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 1, PBL, CC high, n=0, 136, 0	3 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 1, BL, CC high, n=0, 144, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 1, PBL, CC high, n=0, 136, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 2, BL, CC low, n=0, 85, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 2, PBL, CC low, n=0, 92, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 2, BL, CC high, n=0, 85, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 2, PBL, CC high, n=0, 92, 0	5 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 2, BL, CC high, n=0, 85, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 2, PBL, CC high, n=0, 92, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 2, BL, CC high, n=0, 85, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 2, PBL, CC high, n=0, 92, 0	2 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 2, BL, CC high, n=0, 85, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 2, PBL, CC high, n=0, 92, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 2, BL, CC low, n=0, 85, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 2, PBL, CC low, n=0, 92, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 2, BL, CC high, n=0, 85, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 2, PBL, CC high, n=0, 92, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 2, BL, CC low, n=0, 85, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 2, PBL, CC low, n=0, 92	7 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 2, BL, CC high, n=0, 85, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 2, PBL, CC high, n=0, 92, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 2, BL, CC high, n=0, 85, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 2,PBL, CC high, n=0, 92, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 2, BL, CC high, n=0, 85, 0	3 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 2, PBL, CC high, n=0, 92, 0	3 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 2, BL, CC high, n=0, 85, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 2, PBL, CC high, n=0, 92, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 2, BL, CC low, n=0, 85, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 2, PBL, CC low, n=0, 92, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 2, BL, CC high, n=0, 85, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 2, PBL, CC high, n=0, 92, 0	3 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 2, BL, CC high, n=0, 85, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 2, PBL, CC high, n=0, 92, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 3, BL, CC low, n=0, 57, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 3, PBL, CC low, n=0, 62, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 3, BL, CC high, n=0, 57, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 3, PBL, CC high, n=0, 62, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 3, BL, CC high, n=0, 57, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 3, PBL, CC high, n=0, 62, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 3, BL, CC high, n=0, 57, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 3, PBL, CC high, n=0, 62, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 3, BL, CC high, n=0, 57, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 3, PBL, CC high, n=0, 62, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 3, BL, CC low, n=0, 57, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 3, PBL, CC low, n=0, 62, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 3, BL, CC high, n=0, 57, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 3, PBL, CC high, n=0, 62, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 3, BL, CC low, n=0, 57, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 3, PBL, CC low, n=0, 62, 0	2 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 3, BL, CC high, n=0, 57, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 3, PBL, CC high, n=0, 62, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 3, BL, CC high, n=0, 57, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 3,PBL, CC high, n=0, 62, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 3, BL, CC high, n=0, 57, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 3, PBL, CC high, n=0, 62, 0	3 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 3, BL, CC high, n=0, 57, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 3, PBL, CC high, n=0, 62, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 3, BL, CC low, n=0, 57, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 3, PBL, CC low, n=0, 62, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 3, BL, CC high, n=0, 57, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 3, PBL, CC high, n=0, 62, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 3, BL, CC high, n=0, 57, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 3, PBL, CC high, n=0, 62, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 4, BL, CC low, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 4, PBL, CC low, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 4, BL, CC high, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 4, PBL, CC high, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 4, BL, CC high, n=0, 28, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 4, PBL, CC high, n=0, 29, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 4, BL, CC high, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 4, PBL, CC high, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 4, BL, CC high, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 4, PBL, CC high, n=0, 29, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 4, BL, CC low, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 4, PBL, CC low, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 4, BL, CC high, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 4, PBL, CC high, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 4, BL, CC low, n=0, 28, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 4, PBL, CC low, n=0, 29, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 4, BL, CC high, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 4, PBL, CC high, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 4, BL, CC high, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 4,PBL, CC high, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 4, BL, CC high, n=0, 28, 0	2 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 4, PBL, CC high, n=0, 29, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 4, BL, CC high, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 4, PBL, CC high, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 4, BL, CC low, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 4, PBL, CC low, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 4, BL, CC high, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 4, PBL, CC high, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 4, BL, CC high, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 4, PBL, CC high, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 5, BL, CC low, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 5, PBL, CC low, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 5, BL, CC high, n=0, 12	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 5, PBL, CC high, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 5, BL, CC high, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 5, PBL, CC high, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 5, BL, CC high, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 5, PBL, CC high, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 5, BL, CC high, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 5, PBL, CC high, n=0, 13, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 5, BL, CC low, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 5, PBL, CC low, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 5, BL, CC high, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 5, PBL, CC high, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 5, BL, CC low, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 5, PBL, CC low, n=0, 13, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 5, BL, CC high, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 5, PBL, CC high, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 5, BL, CC high, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 5,PBL, CC high, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 5, BL, CC high, n=0, 12, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 5, PBL, CC high, n=0, 13, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 5, BL, CC high, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 5, PBL, CC high, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 5, BL, CC low, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 5, PBL, CC low, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 5, BL, CC high, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 5, PBL, CC high, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 5, BL, CC high, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 5, PBL, CC high, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 6, BL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Albumin, TC 6, PBL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 6, BL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALT, TC 6, PBL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 6, BL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course ALP, TC 6, PBL, CC high, n=0, 6, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 6, BL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course AST, TC 6, PBL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 6, BL, CC high, n=0, 6, 0	1 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TBIL, TC 6, PBL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 6, BL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 6, PBL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 6, BL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Calcium, TC 6, PBL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 6, BL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CO2/BCO, TC 6, PBL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 6, BL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course CK, TC 6, PBL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC , BL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Creatinine, TC 6,PBL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 6, BL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course GGT, TC 6, PBL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 6, BL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 6, PBL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 6, BL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Potassium, TC 6, PBL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 6, BL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Urea/BUN, TC 6, PBL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 6, BL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Uric acid, TC 6, PBL, CC high, n=0, 6, 0	0 Participants	—	—

SECONDARY outcome

Timeframe: From baseline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Hematocrit (HCT): 0.75, 1.2; Hemoglobin (Hb): 0.75, 1.2; Monocytes: 0.2, 5 2; Neutrophils total (TNUE): 0.8, 1.6; Platelet count (PC): 0.65, 1.5; Red blood cell count (RBC): 0.7, 5 2; White blood cell count (WBC): 0.7, 1.6.

Outcome measures

Measure	Ofatumumab 700 mg n=143 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 1, BL,CC high, n=0, 143, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 1,PBL,CC high, n=0, 136, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 1, BL, CC low, n=0, 143, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 1, PBL, CC low, n=0, 136, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 1, BL, CC low, n=0, 143, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 1, PBL, CC low, n=0, 136, 0	5 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 1, BL, CC low, n=0, 143, 0	2 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 1, PBL, CC low, n=0, 136, 0	13 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 1, BL, CC high, n=0, 143, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 1, PBL, CC high, n=0, 136, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 1, BL, CC low, n=0, 141, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 1, PBL, CC low, n=0, 136, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 1, BL, CC high, n=0, 141, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 1, PBL, CC high, n=0, 136, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 1, BL, CC low, n=0, 143, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 1, PBL, CC low, n=0, 136, 0	2 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 1, BL, CC low, n=0, 142, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 1, PBL, CC low, n=0, 136, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 1, BL, CC high, n=0, 142, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 1,PBL, CC high, n=0, 136, 0	3 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 1, BL, CC low, n=0, 143, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 1, PBL, CC low, n=0, 136, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 1, BL, CC high, n=0, 143, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 1, PBL, CC high, n=0, 136, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 2, BL,CC high, n=0, 85, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 2,PBL,CC high, n=0, 93, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 2, BL, CC low, n=0, 85, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 2, PBL, CC low, n=0, 93, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 2, PBL, CC low, n=0, 93, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 2, BL, CC high, n=0, 84, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 2, BL, CC low, n=0, 85, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 2, PBL, CC low, n=0, 93, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 2, BL, CC low, n=0, 85, 0	2 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 2, PBL, CC low, n=0, 93, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 2, PBL, CC high, n=0, 93, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 2, BL, CC low, n=0, 85, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 2, PBL, CC low, n=0, 93, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 2, BL, CC high, n=0, 85, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 2, PBL, CC high, n=0, 93, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 2, BL, CC low, n=0, 84, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 3, BL, CC low, n=0, 57, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 2, BL, CC low, n=0, 85, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 2, PBL, CC low, n=0, 92, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 2, BL, CC high, n=0, 85, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 2,PBL, CC high, n=0, 92, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 2, BL, CC low, n=0, 85, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 2, PBL, CC low, n=0, 93, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 2, BL, CC high, n=0, 85, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 2, PBL, CC high, n=0, 93, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 3, BL,CC high, n=0, 58, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 3,PBL,CC high, n=0, 62, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 3, BL, CC low, n=0, 58, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 3, PBL, CC low, n=0, 62, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 3, BL, CC low, n=0, 58, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 3, PBL, CC low, n=0, 62, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 3, BL, CC low, n=0, 58, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 3, PBL, CC low, n=0, 62, 0	3 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 3, BL, CC high, n=0, 58, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 3, PBL, CC high, n=0, 62, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 3, BL, CC low, n=0, 57, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 3, PBL, CC low, n=0, 62, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 3, BL, CC high, n=0, 57, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 3, PBL, CC high, n=0, 62, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 3, BL, CC low, n=0, 58, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 3, PBL, CC low, n=0, 62, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 3, PBL, CC low, n=0, 60, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 3, BL, CC high, n=0, 57, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 3,PBL, CC high, n=0, 60, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 3, BL, CC low, n=0, 58, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 3, PBL, CC low, n=0, 62, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 3, BL, CC high, n=0, 58, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 4, PBL, CC high, n=0, 62, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 4, BL,CC high, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 4,PBL,CC high, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 4, BL, CC low, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 4, PBL, CC low, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 4, BL, CC low, n=0, 28, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 1, PBL, CC low, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 4, BL, CC low, n=0, 28, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 4, PBL, CC low, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 4, BL, CC high, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 4, PBL, CC high, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 4, BL, CC low, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 4, PBL, CC low, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 4, BL, CC high, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 4, PBL, CC high, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 4, BL, CC low, n=0, 28, 0	1 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 4, PBL, CC low, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 4, BL, CC low, n=0, 26, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 4, PBL, CC low, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 4, BL, CC high, n=0, 26, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 4,PBL, CC high, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 4, BL, CC low, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 4, PBL, CC low, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 4, BL, CC high, n=0, 28, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 4, PBL, CC high, n=0, 29, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 5, BL,CC high, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 5,PBL,CC high, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 5, BL, CC low, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 5, PBL, CC low, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 5, BL, CC low, n=0, 12	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 5, PBL, CC low, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 5, BL, CC low, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 5, PBL, CC low, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 5, BL, CC high, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 5, PBL, CC high, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 5, BL, CC low, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 5, PBL, CC low, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 5, BL, CC high, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 5, PBL, CC high, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 5, BL, CC low, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 5, PBL, CC low, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 5, BL, CC low, n=0, 11, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 5, PBL, CC low, n=0, 13	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 5, BL, CC high, n=0, 11	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 5,PBL, CC high, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 5, BL, CC low, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 5, PBL, CC low, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 5, BL, CC high, n=0, 12, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 5, PBL, CC high, n=0, 13, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 6, BL,CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Eosinophils, TC 6,PBL,CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 6, BL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HCT, TC 6, PBL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 6, BL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Hb, TC 6, PBL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 6, BL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 6, PBL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 6, BL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course Monocytes, TC 6, PBL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 6, BL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 6, PBL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 6, BL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course PC, TC 6, PBL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 6, BL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course RBC count, TC 6, PBL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 6, BL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 6, PBL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 6, BL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course TNUE, TC 6,PBL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 6, BL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 6, PBL, CC low, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 6, BL, CC high, n=0, 6, 0	0 Participants	—	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course WBC count, TC 6, PBL, CC high, n=0, 6, 0	0 Participants	—	—

SECONDARY outcome

Timeframe: From baseline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

The baseline value for a treatment course is defined as the value before infusion A of each treatment course. The post-baseline visit is defined as any assessment during or after the start of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern for vital signs (Low, High) are: Diastolic blood pressure (DBP) (millimeters of mercury [mmHg]): 40, 110; Systolic blood pressure (SBP) (mmHg): 90, 170; Heart rate (beats per minute): 35, 120. LLN=lower limit of normal; ULN=upper limit of normal.

Outcome measures

Measure	Ofatumumab 700 mg n=148 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 1, BL, <LLN, n=0, 148, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 1, PBL, <LLN, n=0, 148, 0	2 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 1, BL, >ULN, n=0, 148, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 1, PBL, >ULN, n=0, 148, 0	1 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 1, BL, <LLN, n=0, 148, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 1, PBL, <LLN, n=0, 148, 0	7 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 1, BL, >ULN, n=0, 148, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 1, PBL, >ULN, n=0, 148, 0	7 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 1, BL, <LLN, n=0, 148, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 1, PBL, <LLN, n=0, 148, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 1, BL, >ULN, n=0, 148, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 1, PBL, >ULN, n=0, 148, 0	1 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 2, BL, <LLN, n=0, 93, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 2, PBL, <LLN, n=0, 93, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 2, BL, >ULN, n=0, 93, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 2, PBL, >ULN, n=0, 93, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 2, BL, <LLN, n=0, 93, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 2, PBL, <LLN, n=0, 93, 0	3 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 2, BL, >ULN, n=0, 93, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 2, PBL, >ULN, n=0, 93, 0	6 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 2, BL, <LLN, n=0, 93, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 2, PBL, <LLN, n=0, 93, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 2, BL, >ULN, n=0, 93, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 2, PBL, >ULN, n=0, 93, 0	1 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 3, BL, <LLN, n=0, 62, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 3, PBL, <LLN, n=0, 63, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 3, BL, >ULN, n=0, 62, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 3, PBL, >ULN, n=0, 63, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 3, BL, <LLN, n=0, 62, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 3, PBL, <LLN, n=0, 63, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 3, BL, >ULN, n=0, 62, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 3, PBL, >ULN, n=0, 63, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 3, BL, <LLN, n=0, 62, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 3, PBL, <LLN, n=0, 63, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 3, BL, >ULN, n=0, 62, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 3, PBL, >ULN, n=0, 63, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 4, BL, <LLN, n=0, 29, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 4, PBL, <LLN, n=0, 30, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 4, BL, >ULN, n=0, 29, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 4, PBL, >ULN, n=0, 30, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 4, BL, <LLN, n=0, 29, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 4, PBL, <LLN, n=0, 30, 0	2 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 4, BL, >ULN, n=0, 29, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 4, PBL, >ULN, n=0, 30, 0	1 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 4, BL, <LLN, n=0, 29, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 4, PBL, <LLN, n=0, 30, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 4, BL, >ULN, n=0, 29, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 4, PBL, >ULN, n=0, 30, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 5, BL, <LLN, n=0, 13, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 5, PBL, <LLN, n=0, 13, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 5, BL, >ULN, n=0, 13, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 5, PBL, >ULN, n=0, 13, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 5, BL, <LLN, n=0, 13, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 5, PBL, <LLN, n=0, 13, 0	2 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 5, BL, >ULN, n=0, 13, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 5, PBL, >ULN, n=0, 13, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 5, BL, <LLN, n=0, 13, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 5, PBL, <LLN, n=0, 13, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 5, BL, >ULN, n=0, 13, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 5, PBL, >ULN, n=0, 13, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 6, BL, <LLN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 6, PBL, <LLN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 6, BL, >ULN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course DBP, TC 6, PBL, >ULN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 6, BL, <LLN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 6, PBL, <LLN, n=0, 6, 0	1 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 6, BL, >ULN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course SBP, TC 6, PBL, >ULN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 6, BL, <LLN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 6, PBL, <LLN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 6, BL, >ULN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course HR, TC 6, PBL, >ULN, n=0, 6, 0	0 Participants	—	—

SECONDARY outcome

Timeframe: From baseline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

The baseline value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline visit is defined as any visit after the date of infusion A during the specified treatment course. Reference ranges (LLN, ULN) used for immunoglobulins are: immunoglobulin A (IgA) (grams/Liter): 0.81, 4.63; immunoglobulin G (IgG) (grams/Liter): 6.94, 16.18; immunoglobulin M (IgM) (grams/Liter): 0.48, 2.71.

Outcome measures

Measure	Ofatumumab 700 mg n=141 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 1, BL, <LLN, n=0, 141, 0	1 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 1, PBL, <LLN, n=0, 133, 0	1 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 1, BL, >ULN, n=0, 141, 0	16 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 1, PBL, >ULN, n=0, 133, 0	14 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 1, BL, <LLN, n=0, 141, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 1, PBL, <LLN, n=0, 133, 0	4 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 1, BL, >ULN, n=0, 141, 0	43 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 1, PBL, >ULN, n=0, 133, 0	25 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 1, BL, <LLN, n=0, 141, 0	7 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 1, PBL, <LLN, n=0, 133, 0	18 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 1, BL, >ULN, n=0, 141, 0	19 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 1, PBL, >ULN, n=0, 133, 0	12 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 2, BL, <LLN, n=0, 85, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 2, PBL, <LLN, n=0, 93, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 2, BL, >ULN, n=0, 85, 0	9 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 2, PBL, >ULN, n=0, 93, 0	1 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 2, BL, <LLN, n=0, 85, 0	1 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 2, PBL, <LLN, n=0, 93, 0	3 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 2, BL, >ULN, n=0, 85, 0	11 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 2, PBL, >ULN, n=0, 93, 0	12 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 2, BL, <LLN, n=0, 85, 0	10 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 2, PBL, <LLN, n=0, 93, 0	18 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 2, BL, >ULN, n=0, 85, 0	6 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 2, PBL, >ULN, n=0, 93, 0	5 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 3, BL, <LLN, n=0, 59, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 3, PBL, <LLN, n=0, 62, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 3, BL, >ULN, n=0, 59, 0	5 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 3, PBL, >ULN, n=0, 62, 0	5 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 3, BL, <LLN, n=0, 59, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 3, PBL, <LLN, n=0, 62, 0	2 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 3, BL, >ULN, n=0, 59, 0	6 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 3, PBL, >ULN, n=0, 62, 0	5 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 3, BL, <LLN, n=0, 59, 0	7 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 3, PBL, <LLN, n=0, 62, 0	11 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 3, BL, >ULN, n=0, 59, 0	3 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 3, PBL, >ULN, n=0, 62, 0	2 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 4, BL, <LLN, n=0, 28, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 4, PBL, <LLN, n=0, 29, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 4, BL, >ULN, n=0, 28, 0	4 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 4, PBL, >ULN, n=0, 29, 0	5 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 4, BL, <LLN, n=0, 28, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 4, PBL, <LLN, n=0, 29, 0	1 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 4, BL, >ULN, n=0, 28, 0	1 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 4, PBL, >ULN, n=0, 29, 0	1 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 4, BL, <LLN, n=0, 28, 0	1 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 4, PBL, <LLN, n=0, 29, 0	2 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 4, BL, >ULN, n=0, 28, 0	1 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 4, PBL, >ULN, n=0, 29, 0	1 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 5, BL, <LLN, n=0, 12, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 5, PBL, <LLN, n=0, 13, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 5, BL, >ULN, n=0, 12, 0	2 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 5, PBL, >ULN, n=0, 13, 0	2 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 5, BL, <LLN, n=0, 12, 0	1 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 5, PBL, <LLN, n=0, 13, 0	1 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 5, BL, >ULN, n=0, 12, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 5, PBL, >ULN, n=0, 13, 0	1 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 5, BL, <LLN, n=0, 12, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 5, PBL, <LLN, n=0, 13, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 5, BL, >ULN, n=0, 12, 0	1 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 5, PBL, >ULN, n=0, 13, 0	1 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 6, BL, <LLN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 6, PBL, <LLN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 6, BL, >ULN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgA, TC 6, PBL, >ULN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 6, BL, <LLN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 6, PBL, <LLN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 6, BL, >ULN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgG, TC 6, PBL, >ULN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 6, BL, <LLN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 6, PBL, <LLN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 6, BL, >ULN, n=0, 6, 0	0 Participants	—	—
Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course IgM, TC 6, PBL, >ULN, n=0, 6, 0	0 Participants	—	—

SECONDARY outcome

Timeframe: From basline up to Week 144

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. A positive JC Virus test result indicates the presence of JC Virus.

Outcome measures

Measure	Ofatumumab 700 mg n=118 Participants	Placebo or OFA 700 mg: FU Period	Placebo
Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods TC 1, BL, n=0, 76, 0	1 Participants	—	—
Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods TC 1, PBL, n=0, 118, 0	1 Participants	—	—
Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods TC 2, BL, n=0, 45, 0	0 Participants	—	—
Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods TC 2, PBL, n=0, 81, 0	1 Participants	—	—
Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods TC 3, BL, n=0, 30, 0	1 Participants	—	—
Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods TC 3, PBL, n=0, 48, 0	0 Participants	—	—
Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods TC 4, BL, n=0, 10, 0	0 Participants	—	—
Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods TC 4, PBL, n=0, 25, 0	0 Participants	—	—
Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods TC 5, BL, n=0, 4, 0	0 Participants	—	—
Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods TC 5, PBL, n=0, 8, 0	0 Participants	—	—
Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods TC 6, BL, n=0, 3, 0	0 Participants	—	—
Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods TC 6, PBL, n=0, 6, 0	0 Participants	—	—

SECONDARY outcome

Timeframe: From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from Last Subject Last Visit [LSLV])

Population: Safety Follow-up Population: all participants who withdrew from the Double-blind Period and had evidence of contact with the site after the end of the Double-blind Period and all participants who withdrew or completed the Open-label Period and had evidence of contact with the site after their end of Open-label date.

A serious adverse event 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; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general SAE module for a list of SAEs.

Outcome measures

Measure	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period n=132 Participants	Placebo
Number of Participants With Any Serious Adverse Event During the Follow-up Period	—	17 Participants	—

SECONDARY outcome

Timeframe: From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

The reference ranges for immunoglobulins (LLN, ULN) are defined as: IgA (grams/Liter): 0.81, 4.63; IgG (grams/Liter): 6.94, 16.18; IgM (grams/Liter): 0.48, 2.71.

Outcome measures

Measure	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period n=123 Participants	Placebo
Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period IgA <LLN	—	0 Participants	—
Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period IgA >ULN	—	15 Participants	—
Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period IgG <LLN	—	7 Participants	—
Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period IgG >ULN	—	18 Participants	—
Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period IgM <LLN	—	23 Participants	—
Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period IgM >ULN	—	4 Participants	—

SECONDARY outcome

Timeframe: From the first dose of ofatumumab until the last Follow-up Period visit (up to Week 248)

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Time to first CD19+ B-cell repopulation (return to normal or baseline level) relative to the first dose was assessed only for those participants whose B-cells repopulated after receiving ofatumumab. Time to first CD19+ B-cell repopulation relative to the last dose of ofatumumab was assessed only for those participants whose B-cells repopulated during their last ofatumumab treatment course or follow-up.

Outcome measures

Measure	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period n=63 Participants	Placebo
Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab Relative to first dose, n=0, 0, 63	—	22.013 Months Interval 0.46 to 49.25	—
Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab Relative to last dose, n=0, 0, 60	—	12.567 Months Interval 0.03 to 29.47	—

SECONDARY outcome

Timeframe: From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)

Population: AT Population. Only those participants contributing values at the indicated time point were analyzed.

Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. Positive JC Virus test result indicated presence of JC Virus.

Outcome measures

Measure	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period n=132 Participants	Placebo
Number of Participants With a Positive JC Virus Test Result During the Follow-up Period	—	7 Participants	—

SECONDARY outcome

Timeframe: From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)

Population: AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.

Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: ALT: NA, 2; ALP: NA, 1.5; TBIL: NA, 1.5; CO2/BCO: 0.85, 1.2; CK: NA, 2; GGT: NA, 2; Urea/BUN: NA, 1.5.

Outcome measures

Measure	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period n=132 Participants	Placebo
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period ALT	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period ALP	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period CK	—	2 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period CO2/BCO	—	2 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period GGT	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period TBIL	—	1 Participants	—
Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period Urea/BUN	—	1 Participants	—

SECONDARY outcome

Timeframe: From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)

Population: AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.

Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Total neutrophils: 0.8, 1.6; Platelet count: 0.65, 1.5.

Outcome measures

Measure	Ofatumumab 700 mg	Placebo or OFA 700 mg: FU Period n=132 Participants	Placebo
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period Eosinophils	—	1 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period Total neutrophils	—	2 Participants	—
Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period Platelet count	—	1 Participants	—

Adverse Events

Placebo: DB Period

Serious events: 6 serious events

Other events: 36 other events

Deaths: 0 deaths

Ofatumumab 700 mg: DB and OL Periods

Serious events: 30 serious events

Other events: 133 other events

Deaths: 0 deaths

Placebo or Ofatumumab 700 mg: Follow-up Period

Serious events: 17 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo: DB Period n=83 participants at risk Serious adverse events (SAEs) and non-serious AEs are reported for participants receiving placebo in the DB Period. Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks) in the DB Period.	Ofatumumab 700 mg: DB and OL Periods n=148 participants at risk SAEs and non-serious AEs are reported for participants receiving ofatumumab 700 mg in either the DB or OL Period. Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week \[oral, intramuscular, or subcutaneous\] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).	Placebo or Ofatumumab 700 mg: Follow-up Period n=132 participants at risk SAEs and non-serious AEs are reported for participants receiving either placebo or ofatumumab 700 mg in the Follow-up Period. Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
Immune system disorders Anaphylactic reaction	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.7% 4/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Immune system disorders Hypersensitivity	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	1.4% 2/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Immune system disorders Anaphylactic shock	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Investigations Alanine aminotransferase increased	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	1.4% 2/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Investigations John Cunningham (JC) virus test positive	1.2% 1/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	1.5% 2/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Nervous system disorders Cervical myelopathy	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Nervous system disorders Cerebrovascular accident	1.2% 1/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Skin and subcutaneous tissue disorders Rash	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.76% 1/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Musculoskeletal and connective tissue disorders Arthralgia	1.2% 1/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.76% 1/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Eye disorders Retinal detachment	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Meningitis viral	1.2% 1/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Injury, poisoning and procedural complications Post procedural complication	1.2% 1/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Metabolism and nutrition disorders Diabetes mellitus inadequate control	1.2% 1/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Respiratory, thoracic and mediastinal disorders Pleurisy	1.2% 1/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Eye disorders Cataract	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	1.4% 2/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Urinary tract infection	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	1.4% 2/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Hepatobiliary disorders Bile duct stone	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Cellulitis	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Gastroenteritis	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Herpes oesophagitis	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
General disorders Implant site reaction	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Cardiac disorders Myocardial infarction	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Oesophageal candidiasis	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Oral candidiasis	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Respiratory tract infection	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Urosepsis	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Investigations Transaminases increased	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Gastrointestinal disorders Gastritis	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Pneumonia	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	1.5% 2/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Vascular disorders Deep vein thrombosis	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.76% 1/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Haemophilus infection	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.76% 1/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Injury, poisoning and procedural complications Hip fracture	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.76% 1/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Injury, poisoning and procedural complications Intervertebral disc protrusion	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.76% 1/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.76% 1/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Renal and urinary disorders Nephrolithiasis	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.76% 1/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.76% 1/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.76% 1/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Blood and lymphatic system disorders Pancytopenia	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.76% 1/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Vascular disorders Peripheral ischaemia	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.76% 1/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Pyelonephritis	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.76% 1/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Septic shock	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.76% 1/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.76% 1/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.76% 1/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.68% 1/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).

Other adverse events

Measure	Placebo: DB Period n=83 participants at risk Serious adverse events (SAEs) and non-serious AEs are reported for participants receiving placebo in the DB Period. Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams \[mg\]/week \[oral, intramuscular, or subcutaneous\] for 24 weeks) in the DB Period.	Ofatumumab 700 mg: DB and OL Periods n=148 participants at risk SAEs and non-serious AEs are reported for participants receiving ofatumumab 700 mg in either the DB or OL Period. Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week \[oral, intramuscular, or subcutaneous\] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).	Placebo or Ofatumumab 700 mg: Follow-up Period n=132 participants at risk SAEs and non-serious AEs are reported for participants receiving either placebo or ofatumumab 700 mg in the Follow-up Period. Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
Skin and subcutaneous tissue disorders Rash	2.4% 2/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	35.8% 53/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Skin and subcutaneous tissue disorders Pruritus	2.4% 2/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	10.8% 16/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Respiratory, thoracic and mediastinal disorders Cough	1.2% 1/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	12.8% 19/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	16.2% 24/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Gastroenteritis	4.8% 4/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	6.1% 9/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	13.5% 20/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Skin and subcutaneous tissue disorders Erythema	1.2% 1/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	6.1% 9/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Nasopharyngitis	6.0% 5/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	4.7% 7/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Urinary tract infection	4.8% 4/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	6.1% 9/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Gastrointestinal disorders Abdominal pain	2.4% 2/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.0% 3/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Musculoskeletal and connective tissue disorders Arthralgia	4.8% 4/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Bronchitis	1.2% 1/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	4.7% 7/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Nervous system disorders Dizziness	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	5.4% 8/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	8.8% 13/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Nervous system disorders Headache	3.6% 3/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.7% 4/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Gastrointestinal disorders Nausea	2.4% 2/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	3.4% 5/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Rhinitis	2.4% 2/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.7% 4/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Gastrointestinal disorders Abdominal pain upper	1.2% 1/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	3.4% 5/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Immune system disorders Anaphylactic reaction	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.7% 4/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Investigations Blood pressure increased	2.4% 2/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Gastrointestinal disorders Constipation	3.6% 3/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Immune system disorders Hypersensitivity	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.0% 3/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.4% 2/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.0% 3/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
General disorders Pyrexia	2.4% 2/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.7% 4/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Upper respiratory tract infection	2.4% 2/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	4.1% 6/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Investigations Alanine aminotransferase increased	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	3.4% 5/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Cervicitis	2.4% 2/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Gastrointestinal disorders Diarrhoea	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	4.1% 6/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Eye disorders Dry eye	2.4% 2/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.0% 3/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Vascular disorders Flushing	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	4.1% 6/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Herpes zoster	2.4% 2/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	3.4% 5/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Vascular disorders Hypertension	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	5.4% 8/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Vascular disorders Hypotension	2.4% 2/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Onychomycosis	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.0% 3/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.0% 3/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Pharyngitis	2.4% 2/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.0% 3/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Gastrointestinal disorders Sensation of foreign body	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.0% 3/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	6.8% 10/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	5.4% 8/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Psychiatric disorders Depression	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	4.1% 6/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Respiratory, thoracic and mediastinal disorders Throat tightness	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	4.1% 6/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Psychiatric disorders Anxiety	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	3.4% 5/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Eye disorders Cataract	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	3.4% 5/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Blood and lymphatic system disorders Anaemia	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.7% 4/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.7% 4/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
General disorders Chest discomfort	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.7% 4/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.7% 4/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
General disorders Chest pain	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.0% 3/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Infections and infestations Erysipelas	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.0% 3/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Psychiatric disorders Insomnia	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.0% 3/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Nervous system disorders Post herpetic neuralgia	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.0% 3/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.0% 3/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Nervous system disorders Sciatica	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.0% 3/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).
Gastrointestinal disorders Vomiting	0.00% 0/83 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	2.0% 3/148 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).	0.00% 0/132 • Because no investigational product was administered during the Follow-up Period, per protocol, only serious adverse events (SAEs) were collected and reported for this period. SAEs/AEs were collected in members of the Safety Population (SP), which is identical to the ITT Population, except that participants were analyzed according to the actual treatment received rather than to the treatment randomized to (one participant was randomized to placebo but received study drug).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER