GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

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ClinicalTrials.gov Identifier: NCT01345253

Recruitment Status : Completed

First Posted : May 2, 2011

Results First Posted : December 2, 2016

Last Update Posted : October 4, 2019

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Human Genome Sciences Inc.

Information provided by (Responsible Party):

GlaxoSmithKline

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Systemic Lupus Erythematosus
Interventions	Drug: Belimumab Drug: Placebo
Enrollment	709

Participant Flow

Recruitment Details	This study consisted of a 52 week blinded treatment period in Northeast Asia (China, Japan, Korea) which was followed by an optional open-label (OL) extension period in China for evaluation of belimumab in participants (par.) with active systemic lupus erythematosus (SLE).
Pre-assignment Details	A total of 707 par. were randomized, 705 received at least 1 dose of investigational product (Safety Population), 677 par. were included in the primary efficacy population (MITT Population) of which 663 were evaluable for the primary endpoint. The participant flow and baseline characteristics are presented for MITT Population (Pop).


Arm/Group Title	Placebo	Belimumab 10 mg/kg
Arm/Group Description	Participants received placebo intra...	Participants received belimumab 10 ...
Arm/Group Description	Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.	Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Period Title: Double-blind (DB) Phase (52 Weeks)
Started	226	451
Completed	170	372
Not Completed	56	79
Reason Not Completed
Adverse Event	22	27
Lack of Efficacy	11	7
Protocol Violation	1	5
Met Protocol Defined Stopping Criteria	6	1
Lost to Follow-up	3	8
Physician Decision	4	12
Withdrawal by Subject	9	19
Period Title: Open-label Phase (Up to Year 5 Week 44)
Started	134 ^[1]	290 ^[2]
Completed	69	146
Not Completed	65	144
Reason Not Completed
Adverse Event	7	18
Death	0	1
Lack of Efficacy	3	7
Protocol Violation	2	5
Lost to Follow-up	4	6
Physician Decision	11	24
Withdrawal by Subject	37	82
Not Recorded	1	1
[1] Only eligible China par. enrolled in OL phase from MITT + additional 9 China par. from Safety Pop [2] Only eligible China par. enrolled in OL phase from MITT + additional 16 China par. from Safety Pop

Baseline Characteristics

Arm/Group Title		Placebo	Belimumab 10 mg/kg	Total
Arm/Group Description		Participants received placebo intra...	Participants received belimumab 10 ...	Total of all reporting groups
Arm/Group Description		Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.	Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.	Total of all reporting groups
Overall Number of Baseline Participants		226	451	677
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	226 participants	451 participants	677 participants
		31.7 (9.18)	32.3 (9.65)	32.1 (9.50)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	226 participants	451 participants	677 participants
	Female	210 92.9%	419 92.9%	629 92.9%
	Male	16 7.1%	32 7.1%	48 7.1%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	226 participants	451 participants	677 participants
Asian - Central/South Asian Heritage		2 0.9%	4 0.9%	6 0.9%
Asian - East Asian Heritage		195 86.3%	403 89.4%	598 88.3%
Asian - Japanese Heritage		24 10.6%	40 8.9%	64 9.5%
Asian - South East Asian Heritage		4 1.8%	3 0.7%	7 1.0%
Asian - Mixed Race		1 0.4%	1 0.2%	2 0.3%

Outcome Measures

1.Primary Outcome


Title	Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase.
Description	SRI response is a composite index, defined as the percent of participa...
Description	SRI response is a composite index, defined as the percent of participants with >=4 point reduction from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score and no worsening (increase of < 0.30 points from Baseline) in physicians global assessment (PGA) and no new British isles lupus assessment group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Modified Intention-to-Treat (MITT) Population: all participants who were randomized and treated with at least one dose of study treatment, with exclusion of participants from the site 086485.


Arm/Group Title	Placebo	Belimumab 10 mg/kg
Arm/Group Description:	Participants received placebo intra...	Participants received belimumab 10 ...
Arm/Group Description:	Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.	Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Overall Number of Participants Analyzed	217	446
Measure Type: Number Unit of Measure: Percentage of participants
	40.1	53.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Belimumab 10 mg/kg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.99
	Confidence Interval	(2-Sided) 95% 1.40 to 2.82
	Estimation Comments	Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement (C) levels (low C3 and/or C4 vs. no low C3 or C4).

2.Secondary Outcome


Title	Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52 for Double-blind Phase.
Description	The SELENA SLEDAI score is a weighted index for assessing SLE disease ...
Description	The SELENA SLEDAI score is a weighted index for assessing SLE disease activity in which signs and symptoms, laboratory tests and physician's assessment for each of 9 organ system were given a weighted score and summed if present at the time of the visit or in the preceding 10 days. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. A decrease of 4 points or more equates to a clinically meaningful improvement. The Baseline value of a variable is defined as the value of the variable measured at Day 0 prior to dosing. In case of multiple results on Day 0 prior to dosing, the latest result was used. If a Day 0 value was not available, the last available value prior to Day 0 was used.
Time Frame	Baseline (Day 0) and Week 52

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	Placebo	Belimumab 10 mg/kg
Arm/Group Description:	Participants received placebo intra...	Participants received belimumab 10 ...
Arm/Group Description:	Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.	Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Overall Number of Participants Analyzed	218	447
Measure Type: Number Unit of Measure: Percentage of participants
	42.2	55.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Belimumab 10 mg/kg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.00
	Confidence Interval	(2-Sided) 95% 1.41 to 2.83
	Estimation Comments	Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).

3.Secondary Outcome


Title	Percent of Participants With SRI7 Response at Week 52 for Double-blind Phase.
Description	SRI7 response is defined as the percent of participants with >=7 po...
Description	SRI7 response is defined as the percent of participants with >=7 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 at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).
Time Frame	Baseline (Day 0) and Week 52

Outcome Measure Data

Analysis Population Description

MITT Population. Only those participants available at the specified time point were analyzed.


Arm/Group Title	Placebo	Belimumab 10 mg/kg
Arm/Group Description:	Participants received placebo intra...	Participants received belimumab 10 ...
Arm/Group Description:	Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.	Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Overall Number of Participants Analyzed	183	367
Measure Type: Number Unit of Measure: Percentage of participants
	23.5	32.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Belimumab 10 mg/kg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0116
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.76
	Confidence Interval	(2-Sided) 95% 1.13 to 2.74
	Estimation Comments	Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).

4.Secondary Outcome


Title	Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Reduced by 50 Percent From Baseline Over 52 Weeks for Double-blind Phase.
Description	Number of days of daily prednisone dose <=7.5 mg/day and/or reduced...
Description	Number of days of daily prednisone dose <=7.5 mg/day and/or reduced by 50 percent over time through each scheduled visit during the blinded period were compared between belimumab and placebo using Rank ANCOVA model which was used for comparing belimumab and placebo. The independent variables in the model included treatment group, Baseline prednisone dose level, country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4). This analysis was perfomed on the participants who used prednisone >7.5 mg/day at Baseline.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

MITT Population


Arm/Group Title	Placebo	Belimumab 10 mg/kg
Arm/Group Description:	Participants received placebo intra...	Participants received belimumab 10 ...
Arm/Group Description:	Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.	Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Overall Number of Participants Analyzed	184	352
Median (Inter-Quartile Range) Unit of Measure: Days
	0.0 (0.0 to 172.0)	0.0 (0.0 to 213.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Belimumab 10 mg/kg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0288
	Comments	[Not Specified]
	Method	Rank ANCOVA
	Comments	[Not Specified]

5.Secondary Outcome


Title	Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks for Double-blind Phase.
Description	Time to first severe SLE flare is defined as the number of days from f...
Description	Time to first severe SLE flare is defined as the number of days from first treatment until the participant had an event (event date-treatement start date +1). If a participant had a severe SFI flare and received protocol restricted medication then the event date was the earliest of the first severe SFI flare date, and the treatment failure date. Analysis of severe SFI flare was performed on the modified SELENA SLEDAI SLE flare index in which the modification excluded severe flares that were triggered only by an increase in SELENA SLEDAI score to >12. Analysis was from Cox proportional hazards model for the comparison between belimumab and placebo adjusting for country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

MITT Population


Arm/Group Title	Placebo	Belimumab 10 mg/kg
Arm/Group Description:	Participants received placebo intra...	Participants received belimumab 10 ...
Arm/Group Description:	Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 milligrams (mg)/kilogram (kg) up to Year 5 Week 28.	Participants received belimumab 10 mg/kg IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the double-blind period. All China participants who completed double-blind period and eligible to enter open-label phase received belimumab 10 mg/kg up to Year 5 Week 28.
Overall Number of Participants Analyzed	226	451
Median (Inter-Quartile Range) Unit of Measure: Days
	NA ^[1] (NA to NA)	NA ^[1] (NA to NA)

[1]

Due to low event rates of participants in both treatment groups having severe SFI flares, the median time and interquartile range could not be estimated.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Belimumab 10 mg/kg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0004
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.50
	Confidence Interval	(2-Sided) 95% 0.34 to 0.73
	Estimation Comments	[Not Specified]

6.Secondary Outcome


Title	Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase
Description	SRI response is a composite index, defined as the percent of participa...
Description	SRI response is a composite index, defined as the percent of participants with >=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 at time of assessment. Excludes participants with a SELENA SLEDAI score <4 at baseline. Participants randomized to belimumab in double-blinded (DB) phase, Baseline is last available value before first belimumab dose received in DB phase. Participants randomized to placebo in DB phase, Baseline is last available value before receiving first belimumab dose in OL phase. Observed case data are presented.Year 6 Week 48 is the Exit Visit obtained by slotting the Exit Visit to Week 48. A SELENA SLEDAI score of 0 (no lupus activity) and a score of 105 (maximum). PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range.
Time Frame	Weeks 24 and 48 for Years 2, 3, 4, 5 and 6

Outcome Measure Data

Analysis Population Description

Efficacy Population: all participants in China who received at least 1 dose of belimumab during open-label phase, exclusive of site 086485. Only those participants available at the specified time points were analyzed (represented by n=x).


Arm/Group Title		Belimumab 10mg/kg (Open-label Phase)
Arm/Group Description:		All eligible China participants who...
Arm/Group Description:		All eligible China participants who had received placebo and belimumab in DB period and entered open-label phase to receive belimumab 10 mg/kg over 1 hour every 28 days from first belimumab date through end of open-label phase.
Overall Number of Participants Analyzed		399
Measure Type: Number Unit of Measure: Percentage of participants
Week 24, Year 2, n=326	Number Analyzed	326 participants
Week 24, Year 2, n=326		66.0
Week 48, Year 2, n=299	Number Analyzed	299 participants
Week 48, Year 2, n=299		69.6
Week 24, Year 3, n=271	Number Analyzed	271 participants
Week 24, Year 3, n=271		72.3
Week 48, Year 3, n=247	Number Analyzed	247 participants
Week 48, Year 3, n=247		70.9
Week 24, Year 4, n=233	Number Analyzed	233 participants
Week 24, Year 4, n=233		71.7
Week 48, Year 4, n=194	Number Analyzed	194 participants
Week 48, Year 4, n=194		76.8
Week 24, Year 5, n= 156	Number Analyzed	156 participants
Week 24, Year 5, n= 156		81.4
Week 48, Year 5, n= 82	Number Analyzed	82 participants
Week 48, Year 5, n= 82		80.5
Week 24, Year 6, n= 36	Number Analyzed	36 participants
Week 24, Year 6, n= 36		86.1
Week 48, Year 6, n= 5	Number Analyzed	5 participants
Week 48, Year 6, n= 5		60.0

Adverse Events

Time Frame	Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44.
Adverse Event Reporting Description	SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug. The first belimumab date was first dose received in DB phase for participants randomized to belimumab in DB phase; first dose received in OL phase for participants randomized to placebo in DB phase.

Arm/Group Title	Placebo (Double-blind Phase)	Belimumab 10 mg/kg (Double-blind Phase)	Belimumab 10 mg/kg (Open-label Phase)
Arm/Group Description	Participants received placebo intra...	Participants received belimumab 10 ...	All eligible China participants who...
Arm/Group Description	Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.	Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.	All eligible China participants who had received placebo and belimumab in DB period and entered open-label phase to receive belimumab 10 mg/kg over 1 hour every 28 days from first belimumab date through end of open-label phase.
All-Cause Mortality
	Placebo (Double-blind Phase)	Belimumab 10 mg/kg (Double-blind Phase)	Belimumab 10 mg/kg (Open-label Phase)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/235 (0.43%)	0/470 (0.00%)	1/424 (0.24%)
Serious Adverse Events Serious Adverse Events
	Placebo (Double-blind Phase)	Belimumab 10 mg/kg (Double-blind Phase)	Belimumab 10 mg/kg (Open-label Phase)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	43/235 (18.30%)	58/470 (12.34%)	96/424 (22.64%)
Blood and lymphatic system disorders
Pancytopenia ^† 1	1/235 (0.43%)	1/470 (0.21%)	0/424 (0.00%)
Histiocytosis haematophagic ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Leukopenia ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Anaemia ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Granulocytopenia ^† 2	0/235 (0.00%)	0/470 (0.00%)	2/424 (0.47%)
Thrombocytopenia ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Haemolytic anaemia ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Cardiac disorders
Cardiomyopathy ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Cardiac failure ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Myocardial ischaemia ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Wolff-Parkinson-White syndrome ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Congenital, familial and genetic disorders
Dermoid cyst ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Ear and labyrinth disorders
Vertigo ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Vertigo positional ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Eye disorders
Cataract ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Glaucoma ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Retinal detachment ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	0/235 (0.00%)	2/470 (0.43%)	1/424 (0.24%)
Allergic colitis ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Haemorrhoidal haemorrhage ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Lupus pancreatitis ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Oesophageal varices haemorrhage ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Pancreatitis chronic ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Ascites ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Chronic gastritis ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Gastric varices haemorrhage ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Haemorrhoids ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Intestinal obstruction ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Intestinal perforation ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Intestinal pseudo-obstruction ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Upper gastrointestinal haemorrhage ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
General disorders
Pyrexia ^† 1	4/235 (1.70%)	2/470 (0.43%)	1/424 (0.24%)
Generalised oedema ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Polyserositis ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Chest discomfort ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Granuloma ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Peripheral swelling ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Hepatobiliary disorders
Hepatic function abnormal ^† 1	0/235 (0.00%)	2/470 (0.43%)	2/424 (0.47%)
Cholelithiasis ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Infections and infestations
Herpes zoster ^† 1	2/235 (0.85%)	6/470 (1.28%)	6/424 (1.42%)
Pneumonia ^† 1	1/235 (0.43%)	2/470 (0.43%)	4/424 (0.94%)
Appendicitis ^† 1	0/235 (0.00%)	2/470 (0.43%)	2/424 (0.47%)
Lung infection ^† 1	2/235 (0.85%)	0/470 (0.00%)	2/424 (0.47%)
Pyelonephritis acute ^† 1	0/235 (0.00%)	2/470 (0.43%)	0/424 (0.00%)
Salmonella sepsis ^† 1	2/235 (0.85%)	0/470 (0.00%)	0/424 (0.00%)
Skin infection ^† 1	1/235 (0.43%)	1/470 (0.21%)	0/424 (0.00%)
Arthritis salmonella ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Bacterial pyelonephritis ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Cellulitis ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Cellulitis streptococcal ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Cystitis ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Cytomegalovirus infection ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Disseminated tuberculosis ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Enteritis infectious ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Escherichia urinary tract infection ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Gastroenteritis ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Gastrointestinal fungal infection ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Infectious colitis ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Lymph node tuberculosis ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Meningitis tuberculous ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Otitis media acute ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Pneumonia bacterial ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Pneumonia mycoplasmal ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Pneumonia streptococcal ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Sepsis ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Spleen tuberculosis ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Tuberculosis liver ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Tuberculous pleurisy ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Upper respiratory tract infection bacterial ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Urinary tract infection enterococcal ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Viral upper respiratory tract infection ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Upper respiratory tract infection ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Soft tissue infection ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Pulmonary tuberculosis ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Pneumonia viral ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Periorbital infection ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Periodontitis ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Ludwig angina ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Gingivitis ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Cutaneous tuberculosis ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Breast abscess ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Bartholin's abscess ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Injury, poisoning and procedural complications
Contusion ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Femoral neck fracture ^† 1	1/235 (0.43%)	0/470 (0.00%)	1/424 (0.24%)
Fractured sacrum ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Humerus fracture ^† 1	0/235 (0.00%)	1/470 (0.21%)	1/424 (0.24%)
Jaw fracture ^† 1	0/235 (0.00%)	1/470 (0.21%)	1/424 (0.24%)
Ligament rupture ^† 1	0/235 (0.00%)	1/470 (0.21%)	1/424 (0.24%)
Patella fracture ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Road traffic accident ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Scapula fracture ^† 1	0/235 (0.00%)	1/470 (0.21%)	1/424 (0.24%)
Fall ^† 2	0/235 (0.00%)	0/470 (0.00%)	2/424 (0.47%)
Spinal compression fracture ^† 2	0/235 (0.00%)	0/470 (0.00%)	2/424 (0.47%)
Concussion ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Lip injury ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Meniscus injury ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Multiple fractures ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Post procedural haemorrhage ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Thermal burn ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Thoracic vertebral fracture ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Investigations
Blood creatinine increased ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Platelet count decreased ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Protein urine present ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Metabolism and nutrition disorders
Hyperkalaemia ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Hypoproteinaemia ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Musculoskeletal and connective tissue disorders
SLE arthritis ^† 1	2/235 (0.85%)	0/470 (0.00%)	0/424 (0.00%)
Intervertebral disc protrusion ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Synovial cyst ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Tenosynovitis ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Loose body in joint ^† 2	0/235 (0.00%)	0/470 (0.00%)	2/424 (0.47%)
Osteonecrosis ^† 2	0/235 (0.00%)	0/470 (0.00%)	6/424 (1.42%)
Arthralgia ^† 2	0/235 (0.00%)	0/470 (0.00%)	2/424 (0.47%)
Systemic lupus erythematosus ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma ^† 1	0/235 (0.00%)	2/470 (0.43%)	2/424 (0.47%)
Anogenital warts ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Benign breast neoplasm ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Cervix carcinoma ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Ovarian adenoma ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Thyroid adenoma ^† 1	0/235 (0.00%)	1/470 (0.21%)	1/424 (0.24%)
Fibroadenoma of breast ^† 2	0/235 (0.00%)	0/470 (0.00%)	2/424 (0.47%)
Benign ear neoplasm ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Benign renal neoplasm ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Haemangioma ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Haemangioma of liver ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Vaginal cancer ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Papillary thyroid cancer ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Nervous system disorders
Lupus encephalitis ^† 1	1/235 (0.43%)	1/470 (0.21%)	1/424 (0.24%)
Brain stem infarction ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Cerebral infarction ^† 1	0/235 (0.00%)	1/470 (0.21%)	1/424 (0.24%)
Dysarthria ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Epilepsy ^† 1	1/235 (0.43%)	0/470 (0.00%)	1/424 (0.24%)
Syncope ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Cerebrovascular insufficiency ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Hypoaesthesia ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Neuropsychiatric lupus ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Noninfectious myelitis ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Abortion spontaneous ^† 2	0/235 (0.00%)	0/470 (0.00%)	2/424 (0.47%)
Foetal growth restriction ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Psychiatric disorders
Acute psychosis ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Suicidal ideation ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Suicide attempt ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Post-traumatic stress disorder ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Renal and urinary disorders
Lupus nephritis ^† 1	5/235 (2.13%)	5/470 (1.06%)	12/424 (2.83%)
Proteinuria ^† 1	2/235 (0.85%)	0/470 (0.00%)	0/424 (0.00%)
Renal failure ^† 1	0/235 (0.00%)	2/470 (0.43%)	0/424 (0.00%)
Haematuria ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Hydronephrosis ^† 1	1/235 (0.43%)	0/470 (0.00%)	1/424 (0.24%)
Lupus cystitis ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Ureteric stenosis ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Nephrolithiasis ^† 2	0/235 (0.00%)	0/470 (0.00%)	2/424 (0.47%)
Ureterolithiasis ^† 2	0/235 (0.00%)	0/470 (0.00%)	2/424 (0.47%)
Reproductive system and breast disorders
Metrorrhagia ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Bartholin's cyst ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Dysfunctional uterine bleeding ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Endometrial thickening ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Menstruation irregular ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Lupus pleurisy ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Lupus pneumonitis ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Pulmonary hypertension ^† 1	0/235 (0.00%)	1/470 (0.21%)	1/424 (0.24%)
Respiratory failure ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Skin and subcutaneous tissue disorders
Dermatitis allergic ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Erythema multiforme ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Systemic lupus erythematosus rash ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Drug eruption ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Erythema ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
Vascular disorders
Arterial rupture ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Deep vein thrombosis ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Lupus vasculitis ^† 1	0/235 (0.00%)	1/470 (0.21%)	0/424 (0.00%)
Necrosis ischaemic ^† 1	0/235 (0.00%)	1/470 (0.21%)	2/424 (0.47%)
Phlebitis ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Varicose vein ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Vasculitis ^† 1	1/235 (0.43%)	0/470 (0.00%)	0/424 (0.00%)
Thrombophlebitis superficial ^† 2	0/235 (0.00%)	0/470 (0.00%)	1/424 (0.24%)
1 Term from vocabulary, MedDRA 18.1 2 Term from vocabulary, MedDRA 21.1 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo (Double-blind Phase)	Belimumab 10 mg/kg (Double-blind Phase)	Belimumab 10 mg/kg (Open-label Phase)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	108/235 (45.96%)	207/470 (44.04%)	263/424 (62.03%)
Gastrointestinal disorders
Diarrhoea ^† 1	14/235 (5.96%)	28/470 (5.96%)	28/424 (6.60%)
General disorders
Pyrexia ^† 1	17/235 (7.23%)	28/470 (5.96%)	36/424 (8.49%)
Infections and infestations
Upper respiratory tract infection ^† 1	39/235 (16.60%)	65/470 (13.83%)	149/424 (35.14%)
Nasopharyngitis ^† 1	26/235 (11.06%)	56/470 (11.91%)	24/424 (5.66%)
Viral upper respiratory tract infection ^† 1	15/235 (6.38%)	33/470 (7.02%)	59/424 (13.92%)
Upper respiratory tract infection bacterial ^† 1	12/235 (5.11%)	16/470 (3.40%)	37/424 (8.73%)
Urinary tract infection ^† 2	11/235 (4.68%)	21/470 (4.47%)	41/424 (9.67%)
Herpes zoster ^† 2	10/235 (4.26%)	23/470 (4.89%)	34/424 (8.02%)
Urinary tract infection bacterial ^† 2	2/235 (0.85%)	20/470 (4.26%)	23/424 (5.42%)
Metabolism and nutrition disorders
Hypokalaemia ^† 2	8/235 (3.40%)	11/470 (2.34%)	24/424 (5.66%)
Nervous system disorders
Headache ^† 1	16/235 (6.81%)	23/470 (4.89%)	20/424 (4.72%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	16/235 (6.81%)	30/470 (6.38%)	30/424 (7.08%)
1 Term from vocabulary, MedDRA 18.1 2 Term from vocabulary, MedDRA 21.1 † Indicates events were collected by systematic assessment

Limitations and Caveats

The primary objective for DB was efficacy and the participant flow is aligned with the MITT population. The primary objective for OL is safety and includes only China par. from DB + additional 25 China par. from the Safety Pop who were not in MITT.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	GSK Response Center
Organization:	GlaxoSmithKline
Phone:	866-435-7343
EMail:	GSKClinicalSupportHD@gsk.com

Publications:

Zhang F, Bae SC, Bass D, Chu M, Egginton S, Gordon D, Roth DA, Zheng J, Tanaka Y. A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea. Ann Rheum Dis. 2018 Mar;77(3):355-363. doi: 10.1136/annrheumdis-2017-211631. Epub 2018 Jan 2.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zhang F, Zheng J, Li Y, Wang G, Wang M, Su Y, Gu J, Li X, Bass D, Chu M, Curtis P, DeRose K, Kurrasch R, Lowe J, Meizlik P, Roth DA. Phase 3, long-term, open-label extension period of safety and efficacy of belimumab in patients with systemic lupus erythematosus in China, for up to 6 years. RMD Open. 2022 Apr;8(1):e001669. doi: 10.1136/rmdopen-2021-001669.

Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.

Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.

Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3):e001747. doi: 10.1136/rmdopen-2021-001747.

Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

Layout table for additonal information

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01345253
Other Study ID Numbers:	113750
First Submitted:	April 28, 2011
First Posted:	May 2, 2011
Results First Submitted:	June 9, 2016
Results First Posted:	December 2, 2016
Last Update Posted:	October 4, 2019

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