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The Evaluation of Belimumab in Myasthenia Gravis (MG)

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ClinicalTrials.gov Identifier: NCT01480596
Recruitment Status : Completed
First Posted : November 29, 2011
Results First Posted : April 27, 2016
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Myasthaenia Gravis
Interventions Biological: Belimumab
Other: Placebo
Enrollment 40
Recruitment Details Participants (par.) with myasthenia gravis (MG) and who were acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) antibody positive, on current standard of care therapy and continued to exhibit signs of MG were eligible for participation in the study.
Pre-assignment Details The study was conducted in 3 phases: a 4 week screening period, a 24 week Treatment (trt) Period, and a 12 week Follow-up period. A total of 40 par. were enrolled, however 1 par. withdrew due to MG exacerbation on Day 7 prior to the first efficacy assessment; therefore, 39 par. comprise the Intent-to-Treat (ITT) Population.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description Participants received 250 milliliter (ml) of a normal saline placebo administered as intravenous (IV) infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period. Participants received 10 milligrams per kilogram (mg/kg) of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Period Title: Overall Study
Started 22 18
Completed 17 16
Not Completed 5 2
Reason Not Completed
Adverse Event             3             0
MG exacerbation or change in medication             2             2
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV Total
Hide Arm/Group Description Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period. Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period. Total of all reporting groups
Overall Number of Baseline Participants 21 18 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 18 participants 39 participants
59.0  (13.88) 52.7  (17.32) 56.1  (15.67)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 18 participants 39 participants
Female
14
  66.7%
10
  55.6%
24
  61.5%
Male
7
  33.3%
8
  44.4%
15
  38.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 18 participants 39 participants
American Indian or Alaskan Native 1 0 1
Asian - East Asian Heritage 1 1 2
White - White/Caucasian/European Heritage 19 17 36
1.Primary Outcome
Title Mean Change From Baseline for Quantitative Myasthenia Gravis (QMG) Score at Week 24
Hide Description The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means were presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline QMG Score, Treatment by Visit, and Baseline QMG Score by Visit.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population includes participants in the Safety Population who has provided any post treatment efficacy assessment.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 17 17
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.37  (1.099) -4.21  (1.143)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.256
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.84
Confidence Interval (2-Sided) 95%
-5.08 to 1.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.592
Estimation Comments Standard error of mean is for adjusted difference.
2.Secondary Outcome
Title Number of Participants With Improvement by Greater Than or Equal to (>=) 3 Points From Baseline Through to Week 24 in the QMG Score
Hide Description The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Proportions compared using exact analyses stratified by the observed median Baseline score (less than or equal to [<=] median, greater than [ >] median). Exact odds ratio, double the exact one-sided p-value and exact confidence intervals were presented. Participants with missing data were assumed to have a negative response.
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 21 18
Measure Type: Number
Unit of Measure: Number of participants
6 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments [Not Specified]
Method exact methods
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.81
Confidence Interval 95%
0.87 to 19.02
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Worsening by >=3 Points in QMG Score From Baseline Through to Week 24
Hide Description The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Proportions compared using exact analyses stratified by the observed median Baseline score (<=median, > median). Exact odds ratio, double the exact one-sided p-value and exact confidence interval were presented. Participants with missing data were assumed to have a worsening response.
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 21 18
Measure Type: Number
Unit of Measure: Number of participants
4 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.827
Comments [Not Specified]
Method exact methods
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.55
Confidence Interval 95%
0.05 to 4.35
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With a Sustained Response in the QMG Score
Hide Description A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Odds ratios are calculated by Cochran-Mantel-Haenszel method stratified by the observed median baseline score (<= median, > median). Wald confidence intervals and p-values were presented.
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 21 18
Measure Type: Number
Unit of Measure: Number of participants
5 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.184
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.51
Confidence Interval (2-Sided) 95%
0.62 to 10.10
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Median Time to QMG Response Which is Sustained From Earliest Time Point at Which Improvement by >=3 Points From Baseline is Observed and Maintained Through Week 24
Hide Description A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores.
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
As per the criteria documented in the Reporting and Analysis Plan these analyses were not conducted since <50% of subjects met the criteria (i.e. had the event in question).
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Mean Change From Baseline for QMG Score at Week 28, Week 32 and Week 36
Hide Description The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. Total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (mild) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at baseline (BL) is the average of the screening and Week 0 BL scores. Change from BL was calculated by subtracting the BL value from the post-BL value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative trt difference indicates benefit relative to placebo. Analysis method was Mixed-Model Repeated Measures adjusted for Trt, Visit, BL QMG Score, Trt by Visit and BL QMG Score by Visit. Only follow-up visits are presented but the analysis also includes all trt phase visits. Only those par. available at indicated time points (represented by n=X in the category titles) were analyzed.
Time Frame Baseline, Week 28, Week 32 and Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 21 18
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 28, n=16, 14 -3.33  (0.839) -5.03  (0.889)
Week 32, n=15, 16 -2.82  (0.880) -4.12  (0.904)
Week 36, n=17, 14 -2.44  (0.872) -4.73  (0.921)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.70
Confidence Interval (2-Sided) 95%
-4.20 to 0.80
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.228
Estimation Comments Analysis for Week 28. Standard error of mean is for adjusted difference.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.310
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -1.31
Confidence Interval (2-Sided) 95%
-3.89 to 1.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.267
Estimation Comments Analysis for Week 32. Standard error of mean is for adjusted difference.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.081
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -2.29
Confidence Interval (2-Sided) 95%
-4.88 to 0.30
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.272
Estimation Comments Analysis for Week 36. Standard error of mean is for adjusted difference.
7.Secondary Outcome
Title Mean Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Through to Week 24
Hide Description The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MGC Score, Treatment by Visit, and Baseline MGC Score by Visit.
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 17 17
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-3.86  (1.037) -3.81  (1.064)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.972
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-2.97 to 3.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.486
Estimation Comments Standard error of mean is for adjusted difference.
8.Secondary Outcome
Title Number of Participants With Improvement by >=3 Points From Baseline Through to Week 24 in the MGC Score
Hide Description The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Proportions compared using exact analyses stratified by the observed median baseline score (<= median, > median). Exact odds ratios, double the exact one-sided p-values and exact confidence intervals were presented. Participants with missing data were assumed to have a negative response.
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 21 18
Measure Type: Number
Unit of Measure: Number of participants
10 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method exact methods
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.26 to 5.48
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants Worsening by >=3 Points From Baseline Through to Week 24 in the MGC Score
Hide Description The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Proportions compared using exact analyses stratified by the observed median baseline score (<= median, > median). Exact odds ratios, double the exact one-sided p-values and exact confidence intervals were presented. Participants with missing data were assumed to have a worsening response.
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 21 18
Measure Type: Number
Unit of Measure: Number of participants
5 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.530
Comments [Not Specified]
Method exact methods
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
0.03 to 2.89
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants With a Sustained Response in the MGC Score
Hide Description AA sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Odds ratios are calculated by Cochran-Mantel-Haenszel method without adjusting for any strata. Wald confidence intervals and p-values were presented.
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 21 18
Measure Type: Number
Unit of Measure: Number of participants
4 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.70
Confidence Interval (2-Sided) 95%
0.64 to 11.46
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Median Time to MGC Response Which is Sustained From Earliest Time Point at Which Improvement by >=3 Points From Baseline is Observed and Maintained Through Week 24
Hide Description A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants' last available assessment prior to initiation of study intravenous (IV) infusion.
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
As per the criteria documented in the Reporting and Analysis Plan these analyses were not conducted since <50% of subjects met the criteria (i.e. had the event in question).
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Mean Change From Baseline for MGC Score at Week 28, Week 32 and Week 36
Hide Description The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participant's last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-BL value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MGC Score, Treatment by Visit, and Baseline MGC Score by Visit. Only follow-up visits are presented but the analysis also includes all treatment phase visits. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.
Time Frame Baseline, Week 28, Week 32 and Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 21 18
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 28, n=16, 14 -4.63  (0.856) -5.64  (0.905)
Week 32, n=15, 16 -5.46  (0.975) -5.44  (0.948)
Week 36, n=17, 14 -4.77  (0.970) -5.04  (1.052)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.423
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.01
Confidence Interval (2-Sided) 95%
-3.56 to 1.53
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.245
Estimation Comments Analysis for Week 28. Standard error of mean is for adjusted difference.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.986
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-2.76 to 2.80
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.361
Estimation Comments Analysis for Week 32. Standard error of mean is for adjusted difference.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.848
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-3.21 to 2.65
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.430
Estimation Comments Analysis for Week 36. Standard error of mean is for adjusted difference.
13.Secondary Outcome
Title Number of Participants With a Myasthenia Foundation of America-post Intervention Status (MGFA-PIS) of Minimal Manifestation or Better at Week 24 and Week 36.
Hide Description Myasthenia Foundation of America-post intervention status assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.
Time Frame Week 24 and Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Number of Participants With MGFA-PIS of Pharmacologic Remission or Better at Week 24 and Week 36
Hide Description Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.
Time Frame Week 24 and Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Number of Participants With MGFA-PIS of Minimal Manifestation Sustained Response (MM at Week 12 and Maintained the Response Through Week 24)
Hide Description Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.
Time Frame Week 12 through Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Number of Participants With MGFA-PIS of Pharmacologic Response Sustained Response (PR at Week 12 and Maintained the Response Through Week 24)
Hide Description Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.
Time Frame Week 12 through Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Number of Participants With MGFA-PIS (Unchanged, Improved, Worsened) at Week 24 and Week 36
Hide Description Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being unchanged, improved or worsened.
Time Frame Week 24 and Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at Week 12 and Week 24
Hide Description The total MG-ADL score was calculated by adding the score of each of the 8 individual MG-ADL questions. Possible total MG-ADL scores ranges from 0 (normal) to 24 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MG-ADL Score, Treatment by Visit, and Baseline MG-ADL Score by Visit. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 21 18
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 12, n=19, 18 -1.33  (0.489) -1.83  (0.511)
Week 24, n=17, 17 -2.01  (0.589) -2.32  (0.603)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.483
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-1.94 to 0.93
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.707
Estimation Comments Statistical analysis is presented for Week 12. Standard error of mean is for adjusted mean difference.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.711
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-2.03 to 1.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.844
Estimation Comments Statistical analysis is presented for Week 24. Standard error of mean is for adjusted mean difference.
19.Secondary Outcome
Title Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at Week 28, Week 32 and Week 36
Hide Description The total MG-ADL score was calculated by adding the score of each of the 8 individual MG-ADL questions. Possible total MG-ADL scores range from 0 (normal) to 24 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participant's last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MG-ADL Score, Treatment by Visit, and Baseline MG-ADL Score by Visit. Only follow-up visits are presented but the analysis also includes all treatment phase visits. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.
Time Frame Baseline, Week 28, Week 32 and Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Number of Participants Analyzed 21 18
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 28, n=16, 14 -1.21  (0.522) -2.96  (0.546)
Week 32, n=15, 16 -1.52  (0.632) -1.80  (0.619)
Week 36, n=17, 14 -1.51  (0.621) -1.78  (0.663)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.75
Confidence Interval (2-Sided) 95%
-3.30 to -0.20
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.757
Estimation Comments Analysis for Week 28. Standard error of mean is for adjusted difference.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.756
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-2.10 to 1.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.887
Estimation Comments Analysis for Week 32. Standard error of mean is for adjusted difference.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo IV, Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.775
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.26
Confidence Interval (2-Sided) 95%
-2.12 to 1.59
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.909
Estimation Comments Analysis for Week 36. Standard error of mean is for adjusted difference.
Time Frame On-treatment serious adverse events (SAEs) and non-serious AEs were collected from the date first infusion of investigational product up to the Week 24 visit.
Adverse Event Reporting Description AEs and SAEs are reported for the safety population which is comprised of participants who had at least one infusion of study agent.
 
Arm/Group Title Placebo IV Belimumab 10 mg/kg IV
Hide Arm/Group Description Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period. Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
All-Cause Mortality
Placebo IV Belimumab 10 mg/kg IV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo IV Belimumab 10 mg/kg IV
Affected / at Risk (%) Affected / at Risk (%)
Total   4/22 (18.18%)   0/18 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis  1  1/22 (4.55%)  0/18 (0.00%) 
Infections and infestations     
Sepsis  1  1/22 (4.55%)  0/18 (0.00%) 
Nervous system disorders     
Myasthenia gravis  1  1/22 (4.55%)  0/18 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis  1  1/22 (4.55%)  0/18 (0.00%) 
Vascular disorders     
Aortic dissection rupture  1  1/22 (4.55%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo IV Belimumab 10 mg/kg IV
Affected / at Risk (%) Affected / at Risk (%)
Total   16/22 (72.73%)   14/18 (77.78%) 
Cardiac disorders     
Atrial fibrillation  1  0/22 (0.00%)  1/18 (5.56%) 
Eye disorders     
Cataract  1  1/22 (4.55%)  1/18 (5.56%) 
Eye pain  1  0/22 (0.00%)  1/18 (5.56%) 
Photopsia  1  0/22 (0.00%)  1/18 (5.56%) 
Gastrointestinal disorders     
Diarrhoea  1  4/22 (18.18%)  1/18 (5.56%) 
Nausea  1  0/22 (0.00%)  3/18 (16.67%) 
Abdominal pain  1  0/22 (0.00%)  1/18 (5.56%) 
Dental caries  1  0/22 (0.00%)  1/18 (5.56%) 
Toothache  1  0/22 (0.00%)  1/18 (5.56%) 
General disorders     
Pyrexia  1  1/22 (4.55%)  2/18 (11.11%) 
Fatigue  1  0/22 (0.00%)  1/18 (5.56%) 
Feeling hot  1  0/22 (0.00%)  1/18 (5.56%) 
Peripheral swelling  1  0/22 (0.00%)  1/18 (5.56%) 
Infections and infestations     
Influenza  1  0/22 (0.00%)  3/18 (16.67%) 
Nasopharyngitis  1  2/22 (9.09%)  1/18 (5.56%) 
Upper respiratory tract infection  1  1/22 (4.55%)  2/18 (11.11%) 
Cystitis  1  2/22 (9.09%)  0/18 (0.00%) 
Urinary tract infection  1  1/22 (4.55%)  1/18 (5.56%) 
Conjunctivitis  1  0/22 (0.00%)  1/18 (5.56%) 
Ear infection  1  0/22 (0.00%)  1/18 (5.56%) 
Herpes zoster  1  0/22 (0.00%)  1/18 (5.56%) 
Sinusitis  1  0/22 (0.00%)  1/18 (5.56%) 
Tooth infection  1  0/22 (0.00%)  1/18 (5.56%) 
Injury, poisoning and procedural complications     
Wound  1  1/22 (4.55%)  1/18 (5.56%) 
Tooth fracture  1  0/22 (0.00%)  1/18 (5.56%) 
Investigations     
Neutrophil count increased  1  0/22 (0.00%)  1/18 (5.56%) 
White blood cell count increased  1  0/22 (0.00%)  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal pain  1  2/22 (9.09%)  2/18 (11.11%) 
Back pain  1  3/22 (13.64%)  0/18 (0.00%) 
Muscle spasms  1  2/22 (9.09%)  1/18 (5.56%) 
Groin pain  1  0/22 (0.00%)  1/18 (5.56%) 
Pain in extremity  1  0/22 (0.00%)  1/18 (5.56%) 
Nervous system disorders     
Headache  1  3/22 (13.64%)  1/18 (5.56%) 
Dizziness  1  1/22 (4.55%)  1/18 (5.56%) 
Sciatica  1  1/22 (4.55%)  1/18 (5.56%) 
Hypoaesthesia  1  0/22 (0.00%)  1/18 (5.56%) 
Lethargy  1  0/22 (0.00%)  1/18 (5.56%) 
Somnolence  1  0/22 (0.00%)  1/18 (5.56%) 
Psychiatric disorders     
Insomnia  1  2/22 (9.09%)  0/18 (0.00%) 
Depression  1  0/22 (0.00%)  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders     
Productive cough  1  2/22 (9.09%)  1/18 (5.56%) 
Dyspnoea  1  1/22 (4.55%)  1/18 (5.56%) 
Oropharyngeal pain  1  2/22 (9.09%)  0/18 (0.00%) 
Epistaxis  1  0/22 (0.00%)  1/18 (5.56%) 
Throat tightness  1  0/22 (0.00%)  1/18 (5.56%) 
Wheezing  1  0/22 (0.00%)  1/18 (5.56%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  0/22 (0.00%)  1/18 (5.56%) 
Erythema  1  0/22 (0.00%)  1/18 (5.56%) 
Photosensitivity reaction  1  0/22 (0.00%)  1/18 (5.56%) 
Vascular disorders     
Hypertension  1  2/22 (9.09%)  1/18 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01480596     History of Changes
Other Study ID Numbers: 115123
First Submitted: October 27, 2011
First Posted: November 29, 2011
Results First Submitted: March 24, 2016
Results First Posted: April 27, 2016
Last Update Posted: February 9, 2017