Trial Outcomes & Findings for A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (NCT NCT01484496)

Last Updated: 2018-06-06

Results Overview

SRI response is defined as \>=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of \<0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (\<=9 vs. \>=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

839 participants

Primary outcome timeframe

Week 52

Results posted on

2018-06-06

Participant Flow

Participants (Par.) with active systemic lupus erythematosus (SLE) and who were on appropriate stable standard SLE therapy for a period of at least 30 days prior to Day 0 before entering the study were eligible for participation in the study.

A total of 1427 par. were screened, out of these 588 par. were screen failures and 839 par. were randomized, of which 836 par. received at least one dose of study treatment. Par. who successfully completed the initial 52-week Double-blind Phase had a choice to enter into a 6-month Open-label Extension Phase of this study.

Participant milestones

Participant milestones
Measure	Placebo SC Par. received placebo administered subcutaneously (SC) once weekly through 51 weeks of thetreatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Belimumab 200 mg SC Par. received belimumab 200 milligrams (mg) administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Open-Label - Placebo SC to Belimumab 200 mg SC Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.	Open-Label - Belimumab 200 SC to Belimumab 200 mg SC Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly
Period 1 STARTED	280	556	0	0
Period 1 COMPLETED	214	463	0	0
Period 1 NOT COMPLETED	66	93	0	0
Period 2 STARTED	0	0	206	456
Period 2 COMPLETED	0	0	191	434
Period 2 NOT COMPLETED	0	0	15	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo SC Par. received placebo administered subcutaneously (SC) once weekly through 51 weeks of thetreatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Belimumab 200 mg SC Par. received belimumab 200 milligrams (mg) administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Open-Label - Placebo SC to Belimumab 200 mg SC Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.	Open-Label - Belimumab 200 SC to Belimumab 200 mg SC Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly
Period 1 Protocol Violation	3	4	0	0
Period 1 Physician Decision	5	1	0	0
Period 1 Lack of Efficacy	10	15	0	0
Period 1 Adverse Event	25	40	0	0
Period 1 Withdrawal by Subject	15	12	0	0
Period 1 Lost to Follow-up	2	6	0	0
Period 1 Positive Pregnancy	1	6	0	0
Period 1 Treatment Failure	3	6	0	0
Period 1 Lack of Compliance	2	1	0	0
Period 1 Unable to Visit Site	0	2	0	0
Period 2 Lack of Efficacy	0	0	1	3
Period 2 Adverse Event	0	0	5	13
Period 2 Other	0	0	9	6

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo SC n=280 Participants Par. received placebo administered SC, once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Belimumab 200 mg SC n=556 Participants Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Total n=836 Participants Total of all reporting groups
Age, Continuous	39.6 Years STANDARD_DEVIATION 12.61 • n=5 Participants	38.1 Years STANDARD_DEVIATION 12.10 • n=7 Participants	38.6 Years STANDARD_DEVIATION 12.29 • n=5 Participants
Sex: Female, Male Female	268 Participants n=5 Participants	521 Participants n=7 Participants	789 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	35 Participants n=7 Participants	47 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian/European Heritage	160 participants n=5 Participants	326 participants n=7 Participants	486 participants n=5 Participants
Race/Ethnicity, Customized Middle East/North African Heritage	6 participants n=5 Participants	10 participants n=7 Participants	16 participants n=5 Participants
Race/Ethnicity, Customized Central Asian Heritage	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized East Asian Heritage	15 participants n=5 Participants	29 participants n=7 Participants	44 participants n=5 Participants
Race/Ethnicity, Customized Japanese Heritage	16 participants n=5 Participants	13 participants n=7 Participants	29 participants n=5 Participants
Race/Ethnicity, Customized South Asian Heritage	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Southeast Asian Heritage	32 participants n=5 Participants	73 participants n=7 Participants	105 participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	30 participants n=5 Participants	56 participants n=7 Participants	86 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	21 participants n=5 Participants	43 participants n=7 Participants	64 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 52

Population: Intention-To-Treat (ITT) Population: comprised of all par. who were randomized and treated with at least one dose of study treatment. Three par. did not have a Baseline PGA assessment; therefore, were not included.

Outcome measures

Outcome measures
Measure	Placebo SC n=279 Participants Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Belimumab 200 mg SC n=554 Participants Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52	48.4 Percentage of par.	61.4 Percentage of par.

SECONDARY outcome

Timeframe: Baseline (Day 0, prior to dosing) to Week 52

Population: ITT population. Only those participants available at that particular timepoints were analyzed.

Time to first severe SLE flare is defined as the number of days from treatment start date until the participant met an event (event date - treatment start date +1). Analyses of severe SLE flare was performed on modified SELENA SLEDAI SLE flare index that excludes severe flares that were triggered only by an increase in SELENA SLEDAI score to \>12 (since this may only represent a modest increase in disease activity). Only post-baseline severe flares were considered.

Outcome measures

Outcome measures
Measure	Placebo SC n=51 Participants Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Belimumab 200 mg SC n=59 Participants Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
Time to First Severe Flare (as Measured by the Modified SLE Flare Index)	118 Days Interval 2.0 to 364.0	171 Days Interval 5.0 to 358.0

SECONDARY outcome

Timeframe: Baseline (Day 0, prior to dosing), Weeks 40 through Week 52

Population: ITT population. Only par. with Baseline prednisone dose \>7.5 mg/day were included.

For the analysis of steroid use, all steroid dosages were converted to a prednisone equivalent in mg. The average daily prednisone dose was calculated taking into account all steroids taken intravenously, intramuscularly, SC, intradermally and orally for both SLE and non-SLE reasons. A responder was defined as having a prednisone reduction by \>=25% from Baseline to \<=7.5 mg/day during Weeks 40 through 52. At Baseline, the average daily prednisone dose was the sum of all prednisone doses over 7 consecutive days up to, but not including Day 0, divided by 7. For this analysis, the average prednisone dose was the total prednisone dose during weeks 40 through 52 divided by the number of days during Weeks 40 through 52. Analysis was performed using a logistic regression model with covariates treatment group, Baseline prednisone dose, Baseline SELENA SLEDAI score, (\<=9 vs \>=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).

Outcome measures

Outcome measures
Measure	Placebo SC n=168 Participants Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Belimumab 200 mg SC n=335 Participants Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline	11.9 Percentage of par.	18.2 Percentage of par.

Adverse Events

Placebo SC

Serious events: 44 serious events

Other events: 218 other events

Deaths: 2 deaths

Belimumab 200 mg SC

Serious events: 60 serious events

Other events: 403 other events

Deaths: 3 deaths

Open-Label - Placebo SC to Belimumab 200 mg SC

Serious events: 14 serious events

Other events: 42 other events

Deaths: 0 deaths

Open-Label - Belimumab 200 SC to Belimumab 200 mg SC

Serious events: 25 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo SC n=280 participants at risk Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Belimumab 200 mg SC n=556 participants at risk Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.	Open-Label - Placebo SC to Belimumab 200 mg SC n=206 participants at risk Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.	Open-Label - Belimumab 200 SC to Belimumab 200 mg SC n=456 participants at risk Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.
Infections and infestations Viral upper respiratory tract infection	8.6% 24/280 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	8.6% 48/556 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	4.4% 9/206 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	3.7% 17/456 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.
Infections and infestations Nasopharyngitis	7.9% 22/280 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	6.8% 38/556 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	4.4% 9/206 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	1.5% 7/456 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.
Infections and infestations Urinary tract infection bacterial	6.4% 18/280 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	7.4% 41/556 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	0.97% 2/206 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	3.1% 14/456 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.
Infections and infestations Upper respiratory tract infection bacterial	5.0% 14/280 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	5.4% 30/556 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	1.5% 3/206 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	2.0% 9/456 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.
Gastrointestinal disorders Nausea	7.9% 22/280 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	6.8% 38/556 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	0.49% 1/206 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	1.1% 5/456 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	5.0% 14/280 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	4.9% 27/556 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	1.5% 3/206 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	1.8% 8/456 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	5.4% 15/280 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	5.0% 28/556 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	1.9% 4/206 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	1.1% 5/456 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	3.9% 11/280 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	5.6% 31/556 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	2.9% 6/206 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	2.4% 11/456 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.
Nervous system disorders Headache	8.9% 25/280 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	10.3% 57/556 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	1.9% 4/206 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	2.2% 10/456 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	6.8% 19/280 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	4.0% 22/556 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	0.49% 1/206 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	1.8% 8/456 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.
Psychiatric disorders Insomnia	7.1% 20/280 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	3.2% 18/556 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	0.00% 0/206 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	0.22% 1/456 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.
Vascular disorders Hypertension	5.0% 14/280 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	4.5% 25/556 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	1.9% 4/206 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.	0.44% 2/456 • Serious adverse events (SAEs) and non-SAEs were collected from start of study drug administration to 51 weeks of treatment period/Exit visit for those par. who withdrew during double-blind treatment, plus another 6 months for open-label treatment period. SAEs and non-SAEs were collected in par. of ITT population, which comprised of par. who were randomized and treated with at least one dose of study treatment.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER