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Trial record 32 of 157 for:    Diseases | ( Map: Costa Rica )

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (BLISS-76)

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ClinicalTrials.gov Identifier: NCT00410384
Recruitment Status : Completed
First Posted : December 12, 2006
Results First Posted : May 5, 2011
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Human Genome Sciences Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Interventions Drug: Placebo
Drug: Belimumab 1 mg/kg
Drug: Belimumab 10 mg/kg
Enrollment 819
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Hide Arm/Group Description Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks. Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks. Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Period Title: Overall Study
Started 275 271 273
Completed 186 199 191
Not Completed 89 72 82
Reason Not Completed
Withdrawal by Subject             28             17             20
Adverse Event             23             18             23
Lack of Efficacy             20             12             17
Lack of Compliance             2             2             2
Lost to Follow-up             4             6             6
Protocol Violation             6             6             6
Physician Decision             3             3             4
Other             3             8             4
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg Total
Hide Arm/Group Description Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks. Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks. Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks. Total of all reporting groups
Overall Number of Baseline Participants 275 271 273 819
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 275 participants 271 participants 273 participants 819 participants
40.0  (11.9) 40.0  (11.4) 40.5  (11.1) 40.2  (11.5)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 275 participants 271 participants 273 participants 819 participants
≤ 45 years 189 184 178 551
Between 45 and 65 years 77 83 92 252
≥ 65 years 9 4 3 16
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 275 participants 271 participants 273 participants 819 participants
Female
252
  91.6%
253
  93.4%
259
  94.9%
764
  93.3%
Male
23
   8.4%
18
   6.6%
14
   5.1%
55
   6.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 275 participants 271 participants 273 participants 819 participants
North America 145 155 136 436
Europe 100 90 105 295
Central America 30 26 32 88
1.Primary Outcome
Title SLE Responder Index (SRI) Response Rate at Week 52
Hide Description

Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.

SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).

Time Frame Baseline, 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a modified intention-to-treat (MITT) population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 52 data.
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Hide Arm/Group Description:
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Overall Number of Participants Analyzed 275 271 273
Measure Type: Number
Unit of Measure: Percentage of participants
33.5 40.6 43.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0167
Comments For the primary analysis of the primary efficacy endpoint, a step-down sequential testing procedure was used to control the type 1 error.
Method Regression, Logistic
Comments Adjusted for baseline stratification factors (SELENA SLEDAI Score: ≤9 vs ≥10; proteinuria: <2g vs ≥2g per 24hr; Race: African/indig-American vs Other)
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.54
Confidence Interval (2-Sided) 95%
1.08 to 2.19
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 1 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0889
Comments After superiority of 10 mg/kg vs placebo was established, the 1 mg/kg group was tested vs placebo (2-sided alpha=0.05)
Method Regression, Logistic
Comments Adjusted for baseline stratification factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
0.95 to 1.94
Estimation Comments [Not Specified]
2.Secondary Outcome
Title SRI Response Rate at Week 76
Hide Description

Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.

SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).

Time Frame Baseline, 76 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 76 data.
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Hide Arm/Group Description:
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Overall Number of Participants Analyzed 275 271 273
Measure Type: Number
Unit of Measure: Percentage of participants
32.4 39.1 38.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1323
Comments [Not Specified]
Method Regression, Logistic
Comments Analysis was adjusted for baseline stratification factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
0.92 to 1.87
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 1 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1050
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.34
Confidence Interval (2-Sided) 95%
0.94 to 1.91
Estimation Comments Analysis was adjusted for baseline stratification factors.
3.Secondary Outcome
Title Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.
Hide Description [Not Specified]
Time Frame Baseline, 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Hide Arm/Group Description:
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Overall Number of Participants Analyzed 275 271 273
Measure Type: Number
Unit of Measure: Percentage of participants
35.3 42.8 46.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0063
Comments [Not Specified]
Method Regression, Logistic
Comments Adjusted for baseline stratification factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.63
Confidence Interval (2-Sided) 95%
1.15 to 2.32
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 1 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0740
Comments [Not Specified]
Method Regression, Logistic
Comments Adjusted for baseline stratification factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.38
Confidence Interval (2-Sided) 95%
0.97 to 1.96
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Change in Physician's Global Assessment (PGA) at Week 24.
Hide Description The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.
Time Frame Baseline, 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Hide Arm/Group Description:
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Overall Number of Participants Analyzed 275 271 273
Mean (Standard Error)
Unit of Measure: Scores on a 3-point scale
-0.49  (0.04) -0.47  (0.04) -0.44  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7962
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for baseline PGA and baseline stratification factors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 1 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9703
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for baseline PGA and baseline stratification factors.
5.Secondary Outcome
Title Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24.
Hide Description The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient’s response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.
Time Frame Baseline, 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Hide Arm/Group Description:
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Overall Number of Participants Analyzed 275 271 273
Mean (Standard Error)
Unit of Measure: Scores on a scale
3.35  (0.51) 3.78  (0.46) 3.21  (0.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6583
Comments [Not Specified]
Method ANCOVA
Comments Analysis adjusted for baseline PCS and baseline stratification factors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 1 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3762
Comments [Not Specified]
Method ANCOVA
Comments Analysis adjusted for baseline PCS and baseline stratification factors.
6.Secondary Outcome
Title Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52
Hide Description [Not Specified]
Time Frame Baseline, Weeks 40-52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Includes only subjects with baseline prednisone dose > 7.5 mg/day.
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Hide Arm/Group Description:
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Overall Number of Participants Analyzed 126 130 120
Measure Type: Number
Unit of Measure: Percentage of participants
12.7 19.2 17.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4253
Comments [Not Specified]
Method Regression, Logistic
Comments Analysis was adjusted for baseline prednisone dose and baseline stratification factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.34
Confidence Interval (2-Sided) 95%
0.65 to 2.74
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 1 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2081
Comments [Not Specified]
Method Regression, Logistic
Comments Analysis was adjusted for baseline prednisone dose and baseline stratification factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.56
Confidence Interval (2-Sided) 95%
0.78 to 3.13
Estimation Comments [Not Specified]
7.Other Pre-specified Outcome
Title Adverse Event (AE) Overview
Hide Description SEE ALSO ADVERSE EVENT RESULTS SECTION
Time Frame Up to 80 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Hide Arm/Group Description:
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Overall Number of Participants Analyzed 275 271 273
Measure Type: Number
Unit of Measure: Percentage of participants
Percent of patients with at least 1 AE 92.0 93.4 92.7
Percent of patients with at least 1 Serious AE 19.6 23.2 22.3
Percent of patients with an AE resulting in death 0.0 0.7 0.4
Time Frame Up to 80 weeks
Adverse Event Reporting Description Includes AEs reported in patients from first dose of study agent throughout the study up to the Week 76/Exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (HGS1006-C1066/NCT00724867 or HGS 1006-C1074/NCT00712933).
 
Arm/Group Title Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Hide Arm/Group Description Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks. Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks. Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
All-Cause Mortality
Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   54/275 (19.64%)   63/271 (23.25%)   61/273 (22.34%) 
Blood and lymphatic system disorders       
Anaemia * 1  2/275 (0.73%)  2/271 (0.74%)  4/273 (1.47%) 
Febrile neutropenia * 1  0/275 (0.00%)  1/271 (0.37%)  1/273 (0.37%) 
Haemolytic anaemia * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Leukopenia * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Lymphopenia * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Neutropenia * 1  1/275 (0.36%)  1/271 (0.37%)  1/273 (0.37%) 
Spontaneous haematoma * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Thrombocytopenia * 1  2/275 (0.73%)  1/271 (0.37%)  1/273 (0.37%) 
Thymus enlargement * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Cardiac disorders       
Acute myocardial infarction * 1  1/275 (0.36%)  0/271 (0.00%)  1/273 (0.37%) 
Angina pectoris * 1  0/275 (0.00%)  0/271 (0.00%)  2/273 (0.73%) 
Atrial fibrillation * 1  2/275 (0.73%)  0/271 (0.00%)  0/273 (0.00%) 
Bradyarrhythmia * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Bradycardia * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Cardiac arrest * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Cardiac failure * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Mitral valve incompetence * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Myocardial infarction * 1  1/275 (0.36%)  0/271 (0.00%)  1/273 (0.37%) 
Myocardial ischaemia * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Pericardial effusion * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Pericarditis * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Pericarditis lupus * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Prinzmetal angina * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Ear and labyrinth disorders       
Vertigo * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Endocrine disorders       
Hyperthyroidism * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Eye disorders       
Chorioretinopathy * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Diplopia * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Gastrointestinal disorders       
Abdominal adhesions * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Abdominal pain * 1  1/275 (0.36%)  3/271 (1.11%)  0/273 (0.00%) 
Diarrhoea * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Erosive oesophagitis * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Food poisoning * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Gastric ulcer * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Gastritis * 1  2/275 (0.73%)  0/271 (0.00%)  0/273 (0.00%) 
Gastrointestinal haemorrhage * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Gastrointestinal inflammation * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Haematemesis * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Ileus * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Intestinal haemorrhage * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Intestinal obstruction * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Lower gastrointestinal haemorrhage * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Nausea * 1  0/275 (0.00%)  1/271 (0.37%)  1/273 (0.37%) 
Pancreatitis * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Pancreatitis acute * 1  2/275 (0.73%)  0/271 (0.00%)  1/273 (0.37%) 
Proctitis * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Upper gastrointestinal haemorrhage * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Varices oesophageal * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Vomiting * 1  1/275 (0.36%)  1/271 (0.37%)  0/273 (0.00%) 
General disorders       
Chest discomfort * 1  1/275 (0.36%)  0/271 (0.00%)  1/273 (0.37%) 
Chills * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Death * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Fatigue * 1  1/275 (0.36%)  1/271 (0.37%)  0/273 (0.00%) 
Infusion related reaction * 1  0/275 (0.00%)  1/271 (0.37%)  3/273 (1.10%) 
Non-cardiac chest pain * 1  4/275 (1.45%)  0/271 (0.00%)  0/273 (0.00%) 
Oedema peripheral * 1  0/275 (0.00%)  0/271 (0.00%)  2/273 (0.73%) 
Pyrexia * 1  2/275 (0.73%)  1/271 (0.37%)  4/273 (1.47%) 
Hepatobiliary disorders       
Autoimmune hepatitis * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Cholecystitis * 1  1/275 (0.36%)  2/271 (0.74%)  0/273 (0.00%) 
Cholecystitis acute * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Cholelithiasis * 1  3/275 (1.09%)  2/271 (0.74%)  1/273 (0.37%) 
Gallbladder non-functioning * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Hepatitis toxic * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Infections and infestations       
Appendicitis * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Arthritis bacterial * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Bronchitis * 1  1/275 (0.36%)  0/271 (0.00%)  3/273 (1.10%) 
Bronchitis bacterial * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Bursitis infective staphylococcal * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Cellulitis * 1  1/275 (0.36%)  1/271 (0.37%)  0/273 (0.00%) 
Cellulitis staphylococcal * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Disseminated cytomegaloviral infection * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Enterocolitis infectious * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Erysipelas * 1  0/275 (0.00%)  2/271 (0.74%)  0/273 (0.00%) 
Escherichia bacteraemia * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Escherichia sepsis * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Fungal skin infection * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Furuncle * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Gastroenteritis * 1  0/275 (0.00%)  1/271 (0.37%)  1/273 (0.37%) 
Gastroenteritis viral * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Gastrointestinal infection * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Gastrointestinal viral infection * 1  0/275 (0.00%)  2/271 (0.74%)  0/273 (0.00%) 
Genital herpes * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Helicobacter gastritis * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Hepatitis B * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Herpes zoster * 1  0/275 (0.00%)  1/271 (0.37%)  1/273 (0.37%) 
Herpes zoster multi-dermatomal * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
HIV infection * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Infected bites * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Infected sebaceous cyst * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Influenza * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Lower respiratory tract infection * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Meningitis aseptic * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Oral candidiasis * 1  1/275 (0.36%)  1/271 (0.37%)  0/273 (0.00%) 
Pneumococcal sepsis * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Pneumonia * 1  4/275 (1.45%)  3/271 (1.11%)  5/273 (1.83%) 
Pneumonia bacterial * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Pyelonephritis * 1  1/275 (0.36%)  2/271 (0.74%)  0/273 (0.00%) 
Pyelonephritis acute * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Skin candida * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Staphylococcal bacteraemia * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Staphylococcal skin infection * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Subcutaneous abscess * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Urinary tract infection * 1  3/275 (1.09%)  3/271 (1.11%)  3/273 (1.10%) 
Urosepsis * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Injury, poisoning and procedural complications       
Anaemia postoperative * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Clavicle fracture * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Deep vein thrombosis postoperative * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Lumbar vertebral fracture * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Meniscus lesion * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Narcotic intoxication * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Operative haemorrhage * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Perirenal haematoma * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Post procedural haematoma * 1  0/275 (0.00%)  0/271 (0.00%)  2/273 (0.73%) 
Procedural complication * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Rib fracture * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Road traffic accident * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Ulna fracture * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Investigations       
Bacteria blood identified * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Metabolism and nutrition disorders       
Dehydration * 1  1/275 (0.36%)  1/271 (0.37%)  1/273 (0.37%) 
Hypokalaemia * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Metabolic acidosis * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Type 2 diabetes mellitus * 1  1/275 (0.36%)  1/271 (0.37%)  0/273 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  1/275 (0.36%)  2/271 (0.74%)  0/273 (0.00%) 
Back pain * 1  1/275 (0.36%)  1/271 (0.37%)  0/273 (0.00%) 
Bursitis * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Costochondritis * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Flank pain * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Intervertebral disc protrusion * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Musculoskeletal chest pain * 1  2/275 (0.73%)  0/271 (0.00%)  0/273 (0.00%) 
Musculoskeletal discomfort * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Myalgia * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Neck pain * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Osteoarthritis * 1  1/275 (0.36%)  1/271 (0.37%)  0/273 (0.00%) 
Osteonecrosis * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Osteoporosis * 1  1/275 (0.36%)  1/271 (0.37%)  0/273 (0.00%) 
Pain in extremity * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Pain in jaw * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Pathological fracture * 1  1/275 (0.36%)  2/271 (0.74%)  0/273 (0.00%) 
Polymyositis * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
SLE arthritis * 1  1/275 (0.36%)  1/271 (0.37%)  1/273 (0.37%) 
Spinal osteoarthritis * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Synovial cyst * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Synovitis * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Temporomandibular joint syndrome * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Benign soft tissue neoplasm * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Bladder papilloma * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Breast cancer * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Carcinoid tumour of the stomach * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Cervix carcinoma stage 0 * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Lipoma * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Ovarian cancer * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Nervous system disorders       
Amnesia * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Brain stem ischaemia * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Convulsion * 1  0/275 (0.00%)  1/271 (0.37%)  1/273 (0.37%) 
Dizziness * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Headache * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Hypoaesthesia * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Intracranial hypotension * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Lupus encephalitis * 1  1/275 (0.36%)  0/271 (0.00%)  1/273 (0.37%) 
Mononeuropathy multiplex * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Myasthenia gravis * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Myelitis transverse * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Neuritis * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Neuropsychiatric lupus * 1  0/275 (0.00%)  0/271 (0.00%)  2/273 (0.73%) 
Peripheral sensory neuropathy * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Reversible posterior leukoencephalopathy syndrome * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Ruptured cerebral aneurysm * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Subarachnoid haemorrhage * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Syncope * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Thalamic infarction * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Vasculitis cerebral * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Psychiatric disorders       
Depression * 1  0/275 (0.00%)  2/271 (0.74%)  2/273 (0.73%) 
Drug abuse * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Insomnia * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Mania * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Renal and urinary disorders       
Cystitis noninfective * 1  2/275 (0.73%)  0/271 (0.00%)  0/273 (0.00%) 
Diabetic nephropathy * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Glomerulonephritis membranous * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Lupus nephritis * 1  5/275 (1.82%)  2/271 (0.74%)  3/273 (1.10%) 
Nephrolithiasis * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Nephrotic syndrome * 1  0/275 (0.00%)  0/271 (0.00%)  2/273 (0.73%) 
Proteinuria * 1  1/275 (0.36%)  0/271 (0.00%)  2/273 (0.73%) 
Renal failure acute * 1  3/275 (1.09%)  0/271 (0.00%)  0/273 (0.00%) 
Reproductive system and breast disorders       
Cervical dysplasia * 1  1/275 (0.36%)  2/271 (0.74%)  0/273 (0.00%) 
Cervix disorder * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Cystocele * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Menorrhagia * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Ovarian cyst * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Postmenopausal haemorrhage * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Uterovaginal prolapse * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Vaginal haemorrhage * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory distress syndrome * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Asthma * 1  1/275 (0.36%)  0/271 (0.00%)  1/273 (0.37%) 
Dyspnoea * 1  2/275 (0.73%)  1/271 (0.37%)  0/273 (0.00%) 
Hypoxia * 1  0/275 (0.00%)  1/271 (0.37%)  0/273 (0.00%) 
Interstitial lung disease * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Organising pneumonia * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Pleural effusion * 1  1/275 (0.36%)  1/271 (0.37%)  1/273 (0.37%) 
Pleurisy * 1  0/275 (0.00%)  0/271 (0.00%)  3/273 (1.10%) 
Pulmonary arterial hypertension * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Pulmonary embolism * 1  0/275 (0.00%)  1/271 (0.37%)  1/273 (0.37%) 
Skin and subcutaneous tissue disorders       
Dermatitis bullous * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Hyperhidrosis * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Skin necrosis * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Skin ulcer * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Systemic lupus erythematosus rash * 1  0/275 (0.00%)  1/271 (0.37%)  1/273 (0.37%) 
Vascular disorders       
Deep vein thrombosis * 1  1/275 (0.36%)  0/271 (0.00%)  2/273 (0.73%) 
Femoral artery embolism * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Hypertension * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Jugular vein thrombosis * 1  0/275 (0.00%)  0/271 (0.00%)  1/273 (0.37%) 
Raynaud's phenomenon * 1  0/275 (0.00%)  1/271 (0.37%)  1/273 (0.37%) 
Subclavian vein thrombosis * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
Vasculitis * 1  1/275 (0.36%)  0/271 (0.00%)  0/273 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Belimumab 1 mg/kg Belimumab 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   213/275 (77.45%)   217/271 (80.07%)   219/273 (80.22%) 
Blood and lymphatic system disorders       
Anaemia * 1  17/275 (6.18%)  7/271 (2.58%)  7/273 (2.56%) 
Gastrointestinal disorders       
Abdominal pain * 1  15/275 (5.45%)  17/271 (6.27%)  18/273 (6.59%) 
Abdominal pain upper * 1  9/275 (3.27%)  19/271 (7.01%)  11/273 (4.03%) 
Diarrhoea * 1  28/275 (10.18%)  34/271 (12.55%)  33/273 (12.09%) 
Gastrooesophageal reflux disease * 1  6/275 (2.18%)  16/271 (5.90%)  6/273 (2.20%) 
Nausea * 1  27/275 (9.82%)  42/271 (15.50%)  45/273 (16.48%) 
Vomiting * 1  18/275 (6.55%)  18/271 (6.64%)  24/273 (8.79%) 
General disorders       
Fatigue * 1  24/275 (8.73%)  26/271 (9.59%)  21/273 (7.69%) 
Oedema peripheral * 1  21/275 (7.64%)  26/271 (9.59%)  25/273 (9.16%) 
Pyrexia * 1  19/275 (6.91%)  22/271 (8.12%)  27/273 (9.89%) 
Infections and infestations       
Bronchitis * 1  20/275 (7.27%)  19/271 (7.01%)  30/273 (10.99%) 
Gastroenteritis * 1  11/275 (4.00%)  15/271 (5.54%)  14/273 (5.13%) 
Influenza * 1  12/275 (4.36%)  19/271 (7.01%)  8/273 (2.93%) 
Nasopharyngitis * 1  24/275 (8.73%)  29/271 (10.70%)  43/273 (15.75%) 
Oral herpes * 1  8/275 (2.91%)  15/271 (5.54%)  11/273 (4.03%) 
Pharyngitis * 1  14/275 (5.09%)  16/271 (5.90%)  16/273 (5.86%) 
Sinusitis * 1  28/275 (10.18%)  21/271 (7.75%)  31/273 (11.36%) 
Upper respiratory tract infection * 1  58/275 (21.09%)  53/271 (19.56%)  54/273 (19.78%) 
Urinary tract infection * 1  41/275 (14.91%)  50/271 (18.45%)  41/273 (15.02%) 
Viral upper respiratory tract infection * 1  12/275 (4.36%)  17/271 (6.27%)  13/273 (4.76%) 
Vulvovaginal mycotic infection * 1  15/275 (5.45%)  18/271 (6.64%)  15/273 (5.49%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  42/275 (15.27%)  42/271 (15.50%)  41/273 (15.02%) 
Back pain * 1  20/275 (7.27%)  25/271 (9.23%)  27/273 (9.89%) 
Myalgia * 1  21/275 (7.64%)  24/271 (8.86%)  19/273 (6.96%) 
Pain in extremity * 1  13/275 (4.73%)  12/271 (4.43%)  24/273 (8.79%) 
SLE arthritis * 1  14/275 (5.09%)  7/271 (2.58%)  9/273 (3.30%) 
Nervous system disorders       
Dizziness * 1  11/275 (4.00%)  14/271 (5.17%)  16/273 (5.86%) 
Headache * 1  38/275 (13.82%)  56/271 (20.66%)  43/273 (15.75%) 
Psychiatric disorders       
Anxiety * 1  10/275 (3.64%)  16/271 (5.90%)  6/273 (2.20%) 
Depression * 1  10/275 (3.64%)  14/271 (5.17%)  19/273 (6.96%) 
Insomnia * 1  13/275 (4.73%)  26/271 (9.59%)  17/273 (6.23%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  15/275 (5.45%)  21/271 (7.75%)  26/273 (9.52%) 
Skin and subcutaneous tissue disorders       
Rash * 1  12/275 (4.36%)  17/271 (6.27%)  20/273 (7.33%) 
Vascular disorders       
Hypertension * 1  20/275 (7.27%)  13/271 (4.80%)  15/273 (5.49%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Human Genome Sciences Inc.
ClinicalTrials.gov Identifier: NCT00410384     History of Changes
Other Study ID Numbers: HGS1006-C1056
BLISS-76
110751 ( Other Identifier: GSK )
First Submitted: December 8, 2006
First Posted: December 12, 2006
Results First Submitted: April 7, 2011
Results First Posted: May 5, 2011
Last Update Posted: February 1, 2017