Trial Outcomes & Findings for A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) (NCT NCT00424476)

Last Updated: 2016-12-12

Results Overview

Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

865 participants

Primary outcome timeframe

Baseline, 52 weeks

Results posted on

2016-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 1 mg/kg Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 10 mg/kg Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Overall Study STARTED	287	288	290
Overall Study COMPLETED	226	240	241
Overall Study NOT COMPLETED	61	48	49

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 1 mg/kg Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 10 mg/kg Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Overall Study Withdrawal by Subject	7	6	3
Overall Study Adverse Event	19	16	15
Overall Study Lack of Efficacy	16	12	12
Overall Study Lack of Compliance	1	1	1
Overall Study Lost to Follow-up	4	6	3
Overall Study Protocol Violation	7	2	3
Overall Study Physician Decision	3	2	3
Overall Study Other	4	3	9

Baseline Characteristics

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=287 Participants Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 1 mg/kg n=288 Participants Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 10 mg/kg n=290 Participants Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Total n=865 Participants Total of all reporting groups
Age, Continuous	36.2 years STANDARD_DEVIATION 11.8 • n=5 Participants	35.0 years STANDARD_DEVIATION 10.6 • n=7 Participants	35.4 years STANDARD_DEVIATION 10.8 • n=5 Participants	35.5 years STANDARD_DEVIATION 11.1 • n=4 Participants
Age, Customized ≤ 45 years	225 participants n=5 Participants	236 participants n=7 Participants	236 participants n=5 Participants	697 participants n=4 Participants
Age, Customized Between 45 and 65 years	57 participants n=5 Participants	48 participants n=7 Participants	52 participants n=5 Participants	157 participants n=4 Participants
Age, Customized ≥ 65 years	5 participants n=5 Participants	4 participants n=7 Participants	2 participants n=5 Participants	11 participants n=4 Participants
Gender Female	270 Participants n=5 Participants	271 Participants n=7 Participants	280 Participants n=5 Participants	821 Participants n=4 Participants
Gender Male	17 Participants n=5 Participants	17 Participants n=7 Participants	10 Participants n=5 Participants	44 Participants n=4 Participants
Region of Enrollment Europe	33 participants n=5 Participants	34 participants n=7 Participants	31 participants n=5 Participants	98 participants n=4 Participants
Region of Enrollment South America	145 participants n=5 Participants	143 participants n=7 Participants	140 participants n=5 Participants	428 participants n=4 Participants
Region of Enrollment Southeast Asia	103 participants n=5 Participants	106 participants n=7 Participants	115 participants n=5 Participants	324 participants n=4 Participants
Region of Enrollment Australia	6 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	15 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 52 weeks

Population: Analysis was performed on a modified intention-to-treat (MITT) population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 52 data.

Outcome measures

Outcome measures
Measure	Placebo n=287 Participants Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 1 mg/kg n=288 Participants Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 10 mg/kg n=290 Participants Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
SLE Responder Index (SRI) Response Rate at Week 52	43.6 Percentage of participants	51.4 Percentage of participants	57.6 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, 52 weeks

Population: Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.

Outcome measures

Outcome measures
Measure	Placebo n=287 Participants Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 1 mg/kg n=288 Participants Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 10 mg/kg n=290 Participants Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.	46.0 Percentage of participants	53.1 Percentage of participants	58.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.

The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=287 Participants Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 1 mg/kg n=288 Participants Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 10 mg/kg n=290 Participants Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Mean Change in Physician's Global Assessment (PGA) at Wk 24.	-0.39 Scores on a 3-point scale Standard Error 0.03	-0.44 Scores on a 3-point scale Standard Error 0.03	-0.54 Scores on a 3-point scale Standard Error 0.03

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.

The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.

Outcome measures

Outcome measures
Measure	Placebo n=287 Participants Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 1 mg/kg n=288 Participants Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 10 mg/kg n=290 Participants Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24.	3.64 Scores on a scale Standard Error 0.42	3.65 Scores on a scale Standard Error 0.43	3.58 Scores on a scale Standard Error 0.46

SECONDARY outcome

Timeframe: Baseline, Weeks 40 through 52

Population: Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Includes only subjects with baseline prednisone dose \> 7.5 mg/day

Outcome measures

Outcome measures
Measure	Placebo n=192 Participants Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 1 mg/kg n=204 Participants Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 10 mg/kg n=204 Participants Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52	12.0 Percentage of participants Interval 0.0 to 0.0	20.6 Percentage of participants Interval 1.08 to 3.31	18.6 Percentage of participants Interval 0.99 to 3.08

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 56 Weeks

Outcome measures

Outcome measures
Measure	Placebo n=287 Participants Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 1 mg/kg n=288 Participants Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 10 mg/kg n=290 Participants Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Adverse Events (AE) Overview Percent of patients with at least 1 AE	91.6 Percentage of participants	91.7 Percentage of participants	91.7 Percentage of participants
Adverse Events (AE) Overview Percent of patients with at least 1 Serious AE	12.5 Percentage of participants	16.3 Percentage of participants	14.1 Percentage of participants
Adverse Events (AE) Overview Percent of patients with an AE resulting in death	1.0 Percentage of participants	0.7 Percentage of participants	1.4 Percentage of participants

Adverse Events

Placebo

Serious events: 36 serious events

Other events: 222 other events

Deaths: 0 deaths

Belimumab 1 mg/kg

Serious events: 47 serious events

Other events: 219 other events

Deaths: 0 deaths

Belimumab 10 mg/kg

Serious events: 41 serious events

Other events: 223 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee For multi-center trials, no investigator will be authorized to publish study results from an individual center until the earlier of the multi-center trial results are published or 12 months after the end or termination of the multi-center trial at all sites. All manuscripts and abstracts must be submitted to the sponsor for review at least 30 days prior to submission for publication or for presentation at a scientific meeting. The sponsor may delay publication for up to 3 months.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Placebo n=287 participants at risk Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 1 mg/kg n=288 participants at risk Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 10 mg/kg n=290 participants at risk Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Psychiatric disorders Intentional self-injury	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Psychiatric disorders Mania	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.34% 1/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Psychiatric disorders Panic attack	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.34% 1/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Psychiatric disorders Personality disorder	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.35% 1/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Blood and lymphatic system disorders Anaemia	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.69% 2/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Blood and lymphatic system disorders Anaemia haemolytic autoimmune	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Blood and lymphatic system disorders Haemolytic anaemia	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.69% 2/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.34% 1/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Blood and lymphatic system disorders Lymphopenia	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.34% 1/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.34% 1/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Cardiac disorders Cardiac arrest	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Cardiac disorders Cardiac failure congestive	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.34% 1/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Cardiac disorders Myocardial infarction	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Cardiac disorders Myocardial ischaemia	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.34% 1/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Cardiac disorders Pericardial effusion	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Cardiac disorders Pericarditis	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.35% 1/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Cardiac disorders Pericarditis lupus	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.34% 1/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Ear and labyrinth disorders Vertigo positional	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.35% 1/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Endocrine disorders Hypothyroidism	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.69% 2/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Eye disorders Blindness unilateral	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.35% 1/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Eye disorders Glaucoma	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.34% 1/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Eye disorders Ocular vasculitis	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.35% 1/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Eye disorders Retinal detachment	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.35% 1/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Abdominal pain	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.35% 1/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Diarrhoea	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Gastritis	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.69% 2/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Haematemesis	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Ileus paralytic	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Lupus enteritis	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.34% 1/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Melaena	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Mesenteric vein thrombosis	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Mouth ulceration	0.00% 0/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.34% 1/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Oesophagitis	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Pancreatitis acute	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Peptic ulcer	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Peritonitis	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.34% 1/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Vasculitis gastrointestinal	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
General disorders Death	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.00% 0/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
General disorders Infusion related reaction	0.35% 1/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.35% 1/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	0.34% 1/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).

Other adverse events
Measure	Placebo n=287 participants at risk Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 1 mg/kg n=288 participants at risk Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.	Belimumab 10 mg/kg n=290 participants at risk Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Blood and lymphatic system disorders Anaemia	4.5% 13/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	4.5% 13/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	5.2% 15/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Abdominal pain upper	6.3% 18/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	2.8% 8/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	4.5% 13/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Diarrhoea	6.6% 19/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	9.7% 28/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	10.3% 30/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Dyspepsia	5.2% 15/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	3.8% 11/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	3.8% 11/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Gastritis	2.4% 7/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	3.5% 10/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	5.2% 15/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Mouth ulceration	6.3% 18/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	1.7% 5/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	4.1% 12/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Nausea	10.8% 31/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	5.6% 16/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	7.9% 23/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Gastrointestinal disorders Vomiting	4.5% 13/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	5.6% 16/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	4.8% 14/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
General disorders Fatigue	4.2% 12/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	5.9% 17/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	6.2% 18/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
General disorders Oedema peripheral	7.3% 21/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	6.9% 20/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	5.9% 17/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
General disorders Pyrexia	5.9% 17/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	5.2% 15/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	5.5% 16/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Infections and infestations Bronchitis	2.4% 7/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	7.3% 21/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	5.5% 16/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Infections and infestations Cystitis	3.1% 9/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	4.2% 12/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	7.6% 22/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Infections and infestations Gastroenteritis	5.6% 16/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	6.9% 20/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	4.1% 12/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Infections and infestations Influenza	8.7% 25/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	7.6% 22/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	11.4% 33/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Infections and infestations Nasopharyngitis	8.0% 23/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	10.4% 30/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	6.9% 20/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Infections and infestations Pharyngitis	2.4% 7/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	5.6% 16/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	5.2% 15/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Infections and infestations Upper respiratory tract infection	16.4% 47/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	14.2% 41/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	12.4% 36/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Infections and infestations Urinary tract infection	8.4% 24/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	9.4% 27/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	9.0% 26/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Musculoskeletal and connective tissue disorders Arthralgia	11.5% 33/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	7.3% 21/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	11.0% 32/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Musculoskeletal and connective tissue disorders Arthritis	6.3% 18/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	4.5% 13/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	5.2% 15/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Musculoskeletal and connective tissue disorders Back pain	8.7% 25/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	8.7% 25/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	6.6% 19/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Nervous system disorders Dizziness	8.0% 23/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	5.6% 16/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	5.2% 15/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Nervous system disorders Headache	26.1% 75/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	20.1% 58/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	22.8% 66/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Psychiatric disorders Insomnia	4.9% 14/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	3.1% 9/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	7.2% 21/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Respiratory, thoracic and mediastinal disorders Cough	8.7% 25/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	8.0% 23/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	5.5% 16/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.2% 15/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	2.1% 6/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	1.0% 3/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Skin and subcutaneous tissue disorders Pruritus	5.9% 17/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	3.5% 10/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	5.9% 17/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).
Vascular disorders Hypertension	10.5% 30/287 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	8.3% 24/288 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).	5.9% 17/290 • Up to 56 weeks. Includes AEs reported in subjects from first dose of study agent throughout the study up to the Week 52/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS 1006-C1074/NCT00712933).