BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01597622
• Collaborator: Human Genome Sciences Inc. (Industry)
• Enrollment: 142
• Locations: 27
• Arm: 1
• Actual Duration (Months): 75.1
• Patients Per Site: 5.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study provides subjects who complete the BEL113750 study and subjects who complete the open-label extension of HGS1006-C1115 (referred to as C1115) Study in Japan the option of continuing treatment with belimumab (10 mg/kg intravenously every 4 weeks) for those randomized to belimumab, or the option to begin treatment with belimumab for those randomized to placebo, as an add-on to their standard of care SLE therapy.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Drug: Belimumab	Phase 3

Detailed Description

This is a multicentre, continuation study of belimumab plus standard of care (SOC) in SLE subjects who completed the Phase III BEL113750 protocol in Northeast Asia or who completed the open-label extension of the HGS1006-C1115 protocol in Japan. This study provides subjects who complete the BEL113750 study the option of continuing treatment with belimumab (10 mg/kg intravenously every 4 weeks) for those randomized to belimumab, or the option to begin treatment with belimumab for those randomized to placebo, as an add-on to their SOC SLE therapy. Subjects participating in this continuation protocol will continue to be monitored for safety and efficacy, as measured by the SLE responder index. Subjects who complete 48 weeks of treatment on the BEL113750 study and who meet inclusion/exclusion criteria, and provide informed consent, will be given the option to enter the continuation study. All subjects will receive belimumab 10 mg/kg IV infused over 1 hour every 4 weeks. Subjects recruited into this study will continue to receive treatment with belimumab until such time as belimumab becomes commercially available in a subject's country of participation, or the subject elects to participate in another belimumab continuation study for SLE, or until either the subject's physician withdraws the subject from the study, or upon the decision by the sponsor to discontinue further development of belimumab for SLE.

Study Design

• Study Type: Interventional
• Actual Enrollment: 142 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: BEL114333, a Multicenter, Continuation Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase III Study BEL113750 in Northeast Asia or Completed the Open-label Extension of HGS1006-C1115 in Japan
• Actual Study Start Date: Jun 11, 2012
• Actual Primary Completion Date: Sep 13, 2018
• Actual Study Completion Date: Sep 13, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Open-label Belimumab Belimumab 10 mg/kg administered intravenously every 4 weeks. All study subjects will receive standard SLE therapies during the study. Subjects will continue to receive belimumab treatment until such time belimumab becomes commercially available in a subject's country of participation, or the subject elects to participate in another belimumab continuation study for SLE, or until either the subject's physician withdraws the subject from the study, or upon the decision by the sponsor to discontinue further development of belimumab for SLE.

Drug: Belimumab; 10 mg/kg administered intravenously over 1 hour every 4 weeks

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [Up to 6 calendar years and 9 months]

   Any untoward medical occurrence in participant, temporally associated with use of medicinal product, whether or not considered related to medicinal product. Any untoward event resulting in death,life threatening,requires hospitalization or prolongation of existing hospitalization,results in disability/incapacity,congenital anomaly/birth defect,medically important were categorized as SAE. Number of participants who had any AE(includes those having non-serious and/or serious AEs) or any SAE are presented.Treatment-emergent AEs are defined as AEs that started on or after first dose of belimumab treatment and for those participants who were randomized to placebo in parent study,ongoing AEs that started before first open-label belimumab dose(in either C1115 open-label extension or BEL114333),worsened (severity,seriousness,relatedness) at any point during the open-label treatment.Timeframe includes exposure in parent study/upto16 weeks post infusion in current study(114333).

Secondary Outcome Measures

1. Percentage of SLE Responder Index (SRI) Responders by Study Visit [Study Years 1 to 7: At Week 24 and 48 Visits, Year 8: only Week 24 Visit]

   SRI response is composite index, defined as percent of participants with>=4 point reduction from Baseline in safety of estrogen in lupus national assessment systemic lupus erythematosus disease activity index (SELENA-SLEDAI) score and no worsening (increase of <0.30 points from Baseline) in physicians global assessment(PGA) &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. 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. Baseline is last available value prior to first belimumab exposure. Year 8 Week 24 visit is the Exit Visit obtained by slotting the Exit Visit to Week 24. Timeframe includes exposure in parent study/upto 4 weeks post infusion (Exit visit) in current study (114333).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have completed the BEL113750 Protocol in Northeast Asia through Week 48 OR have completed the open-label extension of C1115 in Japan.

• Be able to receive the first dose of belimumab for BEL114333 four weeks (minimum of 2 weeks, maximum of 8 weeks) after the last dose in BEL113750 OR be able to receive the first dose of IV belimumab 1 week (plus a 1 week visit window) after the last dose of open-label SC belimumab in C1115..

Exclusion Criteria:

• Have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an adverse event (AE) in the Phase 3 study that could, in the opinion of the principal investigator, put the subject at undue risk.

• Have developed any other medical diseases (e.g., cardiopulmonary), laboratory abnormalities, or conditions (e.g., poor venous access) that in the opinion of the principal investigator, makes the subject unstable for the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Chiba		Japan	275-8580
2	GSK Investigational Site	Ehime		Japan	791-0295
3	GSK Investigational Site	Fukuoka		Japan	807-8555
4	GSK Investigational Site	Fukuoka		Japan	810-8563
5	GSK Investigational Site	Hiroshima		Japan	730-8619
6	GSK Investigational Site	Hiroshima		Japan	739-0002
7	GSK Investigational Site	Hokkaido		Japan	060-8604
8	GSK Investigational Site	Hokkaido		Japan	060-8648
9	GSK Investigational Site	Hyogo		Japan	675-8545
10	GSK Investigational Site	Miyagi		Japan	980-8574
11	GSK Investigational Site	Nagasaki		Japan	857-1195
12	GSK Investigational Site	Okayama		Japan	710-8522
13	GSK Investigational Site	Okinawa		Japan	901-0243
14	GSK Investigational Site	Tochigi		Japan	321-0293
15	GSK Investigational Site	Tokyo		Japan	104-8560
16	GSK Investigational Site	Tokyo		Japan	113-8431
17	GSK Investigational Site	Tokyo		Japan	160-8582
18	GSK Investigational Site	Tokyo		Japan	162-8655
19	GSK Investigational Site	Busan		Korea, Republic of	602-715
20	GSK Investigational Site	Busan		Korea, Republic of
21	GSK Investigational Site	Daegu		Korea, Republic of	700-721
22	GSK Investigational Site	Incheon		Korea, Republic of	400-711
23	GSK Investigational Site	Seoul		Korea, Republic of	110-744
24	GSK Investigational Site	Seoul		Korea, Republic of	133-792
25	GSK Investigational Site	Seoul		Korea, Republic of	137-701
26	GSK Investigational Site	Seoul		Korea, Republic of	150-713
27	GSK Investigational Site	Suwon, Kyonggi-do		Korea, Republic of	443-721

Sponsors and Collaborators

• GlaxoSmithKline
• Human Genome Sciences Inc.

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Statistical Analysis Plan - May 31, 2019
• Study Protocol - May 16, 2014

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01597622
• Other Study ID Numbers: 114333
• First Posted: May 14, 2012
• Last Update Posted: Mar 27, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: SELENA; belimumab; Lupus; systemic lupus erythematosus; PGA; BLys; SLE Flare Index; continuation; phase III; BILAG; extension; efficacy; SRI; B cell; SLEDAI; safety; Asia; B lymphocyte
• Additional relevant MeSH terms: Lupus Erythematosus, Systemic; Belimumab

Study Results

Participant Flow

Recruitment Details	This was multicenter, open-label continuation study of belimumab plus standard of care (SOC) in Systemic Lupus Erythematosus (SLE) participants who completed study BEL113750 (NCT01345253) in Northeast Asia (Japan and Korea) & participants who completed the open-label extension of C1115 (NCT01484496) in Japan to assess long term safety & efficacy.
Pre-assignment Detail	Total 143 participants were screened for this study and 142 participants were enrolled and received study treatment in current study. BEL113750, a 52 week double-blind study; C1115, a 52 week double-blind study followed by a 6 month open-label extension.

Arm/Group Title	Open-label Belimumab 10 mg/kg
Arm/Group Description	Participants received Belimumab 10 milligrams (mg)/kilogram (kg) intravenously (IV) over 1 hour on Week 0, Week 4 and then every 4 weeks until Week 48 of the first year (Study Year 1); on Week 4 and then every 4 weeks until Week 48 of subsequent years during study (up to Study Year 7 Week 4 Visit, which represents a maximum duration of 5 years and 7 months by calendar year in this open-label study. One Study Year is 48 weeks). All participants were continued on their SOC therapies as prescribed by the investigator.
Period Title: Overall Study
STARTED	142
COMPLETED	104
NOT COMPLETED	38

Baseline Characteristics

Arm/Group Title	Open-label Belimumab 10 mg/kg
Arm/Group Description	Participants received Belimumab 10 milligrams (mg)/kilogram (kg) intravenously (IV) over 1 hour on Week 0, Week 4 and then every 4 weeks until Week 48 of the first year (Study Year 1); on Week 4 and then every 4 weeks until Week 48 of subsequent years during study (up to Study Year 7 Week 4 Visit, which represents a maximum duration of 5 years and 7 months by calendar year in this open-label study. One Study Year is 48 weeks). All participants were continued on their SOC therapies as prescribed by the investigator. First belimumab exposure is the first dose in parent study, for participant randomized to belimumab in the parent study; and first OL belimumab dose received (i.e. in either C1115 open-label extension, or BEL114333), for participant randomized to placebo in parent study.
Overall Participants	142
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	34.6 (9.28)
Sex: Female, Male (Count of Participants)
Female	129 90.8%
Male	13 9.2%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaskan Native	1 0.7%
Japanese Heritage	71 50%
East Asian Heritage	68 47.9%
Southeast Asian Heritage	2 1.4%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Description	Any untoward medical occurrence in participant, temporally associated with use of medicinal product, whether or not considered related to medicinal product. Any untoward event resulting in death,life threatening,requires hospitalization or prolongation of existing hospitalization,results in disability/incapacity,congenital anomaly/birth defect,medically important were categorized as SAE. Number of participants who had any AE(includes those having non-serious and/or serious AEs) or any SAE are presented.Treatment-emergent AEs are defined as AEs that started on or after first dose of belimumab treatment and for those participants who were randomized to placebo in parent study,ongoing AEs that started before first open-label belimumab dose(in either C1115 open-label extension or BEL114333),worsened (severity,seriousness,relatedness) at any point during the open-label treatment.Timeframe includes exposure in parent study/upto16 weeks post infusion in current study(114333).
Time Frame	Up to 6 calendar years and 9 months

Outcome Measure Data

Analysis Population Description

Safety Population. All participants in the Enrolled population who received at least one IV dose of belimumab during current study.

Arm/Group Title	Open-label Belimumab 10 mg/kg
Arm/Group Description	Participants received Belimumab 10 milligrams (mg)/kilogram (kg) intravenously (IV) over 1 hour on Week 0, Week 4 and then every 4 weeks until Week 48 of the first year (Study Year 1); on Week 4 and then every 4 weeks until Week 48 of subsequent years during study (up to Study Year 7 Week 4 Visit, which represents a maximum duration of 5 years and 7 months by calendar year in this open-label study. One Study Year is 48 weeks). All participants were continued on their SOC therapies as prescribed by the investigator. First belimumab exposure is the first dose in parent study, for participant randomized to belimumab in the parent study; and first OL belimumab dose received (i.e. in either C1115 open-label extension, or BEL114333), for participant randomized to placebo in parent study.
Measure Participants	142
Any SAEs	48 33.8%
Any AEs	139 97.9%

2. Secondary Outcome

Title	Percentage of SLE Responder Index (SRI) Responders by Study Visit
Description	SRI response is composite index, defined as percent of participants with>=4 point reduction from Baseline in safety of estrogen in lupus national assessment systemic lupus erythematosus disease activity index (SELENA-SLEDAI) score and no worsening (increase of <0.30 points from Baseline) in physicians global assessment(PGA) &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. 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. Baseline is last available value prior to first belimumab exposure. Year 8 Week 24 visit is the Exit Visit obtained by slotting the Exit Visit to Week 24. Timeframe includes exposure in parent study/upto 4 weeks post infusion (Exit visit) in current study (114333).
Time Frame	Study Years 1 to 7: At Week 24 and 48 Visits, Year 8: only Week 24 Visit

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category title)

Arm/Group Title	Open-label Belimumab 10 mg/kg
Arm/Group Description	Participants received Belimumab 10 milligrams (mg)/kilogram (kg) intravenously (IV) over 1 hour on Week 0, Week 4 and then every 4 weeks until Week 48 of the first year (Study Year 1); on Week 4 and then every 4 weeks until Week 48 of subsequent years during study (up to Study Year 7 Week 4 Visit, which represents a maximum duration of 5 years and 7 months by calendar year in this open-label study. One Study Year is 48 weeks). All participants were continued on their SOC therapies as prescribed by the investigator. First belimumab exposure is the first dose in parent study, for participant randomized to belimumab in the parent study; and first OL belimumab dose received (i.e. in either C1115 open-label extension, or BEL114333), for participant randomized to placebo in parent study.
Measure Participants	142
Year 1 Week 24, n=136	47.8 33.7%
Year 1, Week 48, n=133	51.1 36%
Year 2, Week 24, n=129	55.0 38.7%
Year 2, Week 48, n=121	53.7 37.8%
Year 3, Week 24, n=103	57.3 40.4%
Year 3, Week 48, n=88	68.2 48%
Year 4, Week 24, n=80	67.5 47.5%
Year 4, Week 48, n=60	76.7 54%
Year 5, Week 24, n=32	71.9 50.6%
Year 5, Week 48, n=29	69.0 48.6%
Year 6, Week 24, n=24	66.7 47%
Year 6, Week 48, n=22	68.2 48%
Year 7, Week 24, n=18	83.3 58.7%
Year 7, Week 48, n=13	84.6 59.6%
Year 8, Week 24, n=1	100 70.4%

Adverse Events

Time Frame	Treatment-emergent SAEs and non-serious AEs were collected up to maximum duration of 6 calendar years and 9 months.
Adverse Event Reporting Description	Treatment-emergent SAEs and non-serious AEs were reported for the Safety Population consisted of all participants in the enrolled population who received at least one IV dose of belimumab during current study. Timeframe includes exposure in parent study/up to 16 weeks post infusion of treatment in current study 114333.
Arm/Group Title	Open-label Belimumab 10 mg/kg
Arm/Group Description	Participants received Belimumab 10 milligrams (mg)/kilogram (kg) intravenously (IV) over 1 hour on Week 0, Week 4 and then every 4 weeks until Week 48 of the first year (Study Year 1); on Week 4 and then every 4 weeks until Week 48 of subsequent years during study (up to Study Year 7 Week 4 Visit, which represents a maximum duration of 5 years and 7 months by calendar year in this open-label study. One Study Year is 48 weeks). All participants were continued on their SOC therapies as prescribed by the investigator. First belimumab exposure is the first dose in parent study, for participant randomized to belimumab in the parent study; and first OL belimumab dose received (i.e. in either C1115 open-label extension, or BEL114333), for participant randomized to placebo in parent study.
All Cause Mortality
	Open-label Belimumab 10 mg/kg
	Affected / at Risk (%)	# Events
Total	1/142 (0.7%)
Serious Adverse Events
	Open-label Belimumab 10 mg/kg
	Affected / at Risk (%)	# Events
Total	48/142 (33.8%)
Blood and lymphatic system disorders
Leukopenia	1/142 (0.7%)	1
Lymphadenopathy	1/142 (0.7%)	1
Cardiac disorders
Pericarditis lupus	1/142 (0.7%)	1
Ear and labyrinth disorders
Vertigo	1/142 (0.7%)	1
Endocrine disorders
Diabetes insipidus	1/142 (0.7%)	1
Eye disorders
Cataract	1/142 (0.7%)	1
Gastrointestinal disorders
Abdominal pain	1/142 (0.7%)	1
Haemorrhoidal haemorrhage	1/142 (0.7%)	1
Intestinal perforation	1/142 (0.7%)	1
Large intestine polyp	1/142 (0.7%)	2
Lupus pancreatitis	1/142 (0.7%)	1
General disorders
Pyrexia	2/142 (1.4%)	2
Oedema peripheral	1/142 (0.7%)	3
Infections and infestations
Cellulitis	3/142 (2.1%)	3
Herpes zoster	3/142 (2.1%)	3
Endocarditis	2/142 (1.4%)	2
Pyelonephritis acute	2/142 (1.4%)	2
Abscess jaw	1/142 (0.7%)	1
Atypical pneumonia	1/142 (0.7%)	1
Bacterial pyelonephritis	1/142 (0.7%)	1
Escherichia urinary tract infection	1/142 (0.7%)	1
External ear cellulitis	1/142 (0.7%)	1
Gastroenteritis	1/142 (0.7%)	1
Gastroenteritis salmonella	1/142 (0.7%)	1
Genital herpes zoster	1/142 (0.7%)	1
Herpes dermatitis	1/142 (0.7%)	1
Herpes simplex pharyngitis	1/142 (0.7%)	1
Infectious colitis	1/142 (0.7%)	1
Oral herpes	1/142 (0.7%)	1
Pelvic inflammatory disease	1/142 (0.7%)	1
Pneumonia	1/142 (0.7%)	2
Pneumonia bacterial	1/142 (0.7%)	1
Skin infection	1/142 (0.7%)	1
Tonsillitis	1/142 (0.7%)	1
Tuberculous pleurisy	1/142 (0.7%)	1
Viral upper respiratory tract infection	1/142 (0.7%)	1
Injury, poisoning and procedural complications
Contusion	3/142 (2.1%)	3
Ligament rupture	1/142 (0.7%)	1
Post procedural complication	1/142 (0.7%)	1
Radius fracture	1/142 (0.7%)	1
Road traffic accident	1/142 (0.7%)	1
Tibia fracture	1/142 (0.7%)	1
Investigations
Alanine aminotransferase increased	1/142 (0.7%)	1
Aspartate aminotransferase increased	1/142 (0.7%)	1
Protein urine present	1/142 (0.7%)	1
Metabolism and nutrition disorders
Hypoalbuminaemia	1/142 (0.7%)	1
Musculoskeletal and connective tissue disorders
Osteonecrosis	2/142 (1.4%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma	1/142 (0.7%)	1
Uterine leiomyoma	2/142 (1.4%)	2
Nervous system disorders
Brain stem infarction	1/142 (0.7%)	1
Putamen haemorrhage	1/142 (0.7%)	1
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	1/142 (0.7%)	1
Psychiatric disorders
Depression	1/142 (0.7%)	1
Renal and urinary disorders
Acute kidney injury	1/142 (0.7%)	1
Nephrolithiasis	1/142 (0.7%)	1
Ureterolithiasis	1/142 (0.7%)	2
Reproductive system and breast disorders
Menorrhagia	1/142 (0.7%)	1
Respiratory, thoracic and mediastinal disorders
Asphyxia	1/142 (0.7%)	1
Pleurisy	1/142 (0.7%)	1
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus	1/142 (0.7%)	1
Skin ulcer	1/142 (0.7%)	1
Systemic lupus erythematosus rash	1/142 (0.7%)	1
Other (Not Including Serious) Adverse Events
	Open-label Belimumab 10 mg/kg
	Affected / at Risk (%)	# Events
Total	134/142 (94.4%)
Ear and labyrinth disorders
Vertigo	9/142 (6.3%)
Gastrointestinal disorders
Abdominal pain upper	23/142 (16.2%)
Nausea	23/142 (16.2%)
Diarrhoea	22/142 (15.5%)
Constipation	17/142 (12%)
Abdominal pain	16/142 (11.3%)
Vomiting	16/142 (11.3%)
Dental caries	13/142 (9.2%)
Dyspepsia	11/142 (7.7%)
General disorders
Pyrexia	19/142 (13.4%)
Oedema peripheral	11/142 (7.7%)
Infections and infestations
Nasopharyngitis	86/142 (60.6%)
Viral upper respiratory tract infection	25/142 (17.6%)
Herpes zoster	23/142 (16.2%)
Upper respiratory tract infection	22/142 (15.5%)
Influenza	20/142 (14.1%)
Gastroenteritis	18/142 (12.7%)
Pharyngitis	14/142 (9.9%)
Bronchitis	13/142 (9.2%)
Cystitis	12/142 (8.5%)
Oral herpes	11/142 (7.7%)
Urinary tract infection bacterial	11/142 (7.7%)
Hordeolum	9/142 (6.3%)
Conjunctivitis	8/142 (5.6%)
Injury, poisoning and procedural complications
Contusion	16/142 (11.3%)
Ligament sprain	11/142 (7.7%)
Thermal burn	8/142 (5.6%)
Musculoskeletal and connective tissue disorders
Back pain	18/142 (12.7%)
Arthralgia	16/142 (11.3%)
Myalgia	16/142 (11.3%)
Pain in extremity	11/142 (7.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma	8/142 (5.6%)
Nervous system disorders
Headache	40/142 (28.2%)
Dizziness	11/142 (7.7%)
Psychiatric disorders
Insomnia	17/142 (12%)
Reproductive system and breast disorders
Dysmenorrhoea	8/142 (5.6%)
Respiratory, thoracic and mediastinal disorders
Cough	26/142 (18.3%)
Rhinorrhoea	10/142 (7%)
Oropharyngeal pain	9/142 (6.3%)
Rhinitis allergic	9/142 (6.3%)
Skin and subcutaneous tissue disorders
Dermatitis contact	13/142 (9.2%)
Rash	12/142 (8.5%)
Eczema	10/142 (7%)
Acne	9/142 (6.3%)
Urticaria	9/142 (6.3%)
Vascular disorders
Hypertension	11/142 (7.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.