Trial Outcomes & Findings for A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States (NCT NCT00724867)
NCT ID: NCT00724867
Last Updated: 2016-03-28
Results Overview
An AE is defined as any untoward medical occurrence in a participant (par.) temporally associated with the use of a investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
268 participants
Primary outcome timeframe
Up to Week 440
Results posted on
2016-03-28
Participant Flow
Participants with systemic lupus erythematosus who completed the Phase 3 HGS1006-C1056 were enrolled to receive belimumab
Participant milestones
| Measure |
Belimumab 10 mg/kg IV
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Overall Study
STARTED
|
268
|
|
Overall Study
COMPLETED
|
140
|
|
Overall Study
NOT COMPLETED
|
128
|
Reasons for withdrawal
| Measure |
Belimumab 10 mg/kg IV
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Overall Study
Adverse Event
|
25
|
|
Overall Study
Lack of Efficacy
|
14
|
|
Overall Study
Lost to Follow-up
|
12
|
|
Overall Study
Non-compliance with study drug
|
6
|
|
Overall Study
Physician Decision
|
17
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
31
|
|
Overall Study
Sponsor decision to end study
|
14
|
|
Overall Study
Subject incarcerated
|
1
|
|
Overall Study
Developed withdrawal criteria- pregnancy
|
4
|
|
Overall Study
Subject moved out of state
|
1
|
|
Overall Study
Elected to exit due to site closure
|
2
|
Baseline Characteristics
A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States
Baseline characteristics by cohort
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Age, Continuous
|
42.8 Years
STANDARD_DEVIATION 11.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
250 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American/African Heritage
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian: Central Asian Heritage
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian: East Asian Heritage
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian: Japanese Heritage
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian: South Asian Heritage
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian: Southeast Asian Heritage
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White: Middle East/North African Heritage
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White: White/Caucasian/European Heritage
|
183 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 440Population: Modified Intent to Treat (MIIT) Population: The MITT Population comprised of all the participants enrolled in the study who received at least one dose of IP.
An AE is defined as any untoward medical occurrence in a participant (par.) temporally associated with the use of a investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Any time post baseline, n=268
|
267 Participants
|
—
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 0-1, n=268
|
260 Participants
|
—
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 1-2, n=259
|
235 Participants
|
—
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 2-3, n=244
|
206 Participants
|
—
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 3-4, n=219
|
184 Participants
|
—
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 4-5, n=202
|
167 Participants
|
—
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 5-6, n=192
|
145 Participants
|
—
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 6-7, n=130
|
87 Participants
|
—
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 7 plus, n=65
|
31 Participants
|
—
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Any time post baseline, n=268
|
112 Participants
|
—
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 0-1, n=268
|
33 Participants
|
—
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 1-2, n=259
|
30 Participants
|
—
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 2-3, n=244
|
25 Participants
|
—
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 3-4, n=219
|
22 Participants
|
—
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 4-5, n=202
|
24 Participants
|
—
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 5-6, n=192
|
16 Participants
|
—
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 6-7, n=130
|
13 Participants
|
—
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 7 plus, n=65
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: Up Week 440Population: MITT Population
AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent adverse events (AEs) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate = 100\* Number of Events / Participant Years. Participant years were calculated as sum across all participants (\[last visit of interval day - first visit of interval day + 1\]/365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
AE Rates by System Organ Class (SOC) During the Study
Infections and infestations
|
134.4 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Musculoskeletal and connective tissue disorders
|
75.5 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Gastrointestinal disorders
|
53.6 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Injury, poisoning and procedural complications
|
32.3 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Skin and subcutaneous tissue disorders
|
30 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Nervous system disorders
|
29.7 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Respiratory, thoracic and mediastinal disorders
|
28.5 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
General disorders and administration sitecondition
|
27.9 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Psychiatric disorders
|
12.4 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Metabolism and nutrition disorders
|
10.1 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Vascular disorders
|
9.1 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Investigations
|
9.1 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Eye disorders
|
8.2 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Reproductive system and breast disorders
|
6.7 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Cardiac disorders
|
6.4 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Immune system disorders
|
6 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Renal and urinary disorders
|
5.3 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Neoplasms benign, malignant and unspecified
|
5 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Blood and lymphatic system disorders
|
4.4 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Ear and labyrinth disorders
|
3.8 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Hepatobiliary disorders
|
2.3 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Endocrine disorders
|
1.8 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Social circumstances
|
0.8 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Congenital, familial and genetic disorders
|
0.5 Adverse events/100 participant-years
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Pregnancy, puerperium and perinatal conditions
|
0.1 Adverse events/100 participant-years
|
—
|
PRIMARY outcome
Timeframe: Up to Week 440Population: MITT Population
SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate = 100\* Number of Events / participants Years. participants years were calculated as = sum across all participants (\[last visit of interval day - first visit of interval day + 1\]/365). participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
SAE Rates by System Organ Class (SOC) During the Study
Psychiatric disorders
|
0.5 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Reproductive system and breast disorders
|
0.3 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Infections and infestations
|
4 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Gastrointestinal disorders
|
2.2 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Musculoskeletal and connective tissue disorders
|
2 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
General disorders and administration sitecondition
|
1.7 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Nervous system disorders
|
1.4 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Injury, poisoning and procedural complications
|
1.4 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Vascular disorders
|
1 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Neoplasms benign, malignant and unspecified
|
1 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Respiratory, thoracic and mediastinal disorders
|
0.7 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Cardiac disorders
|
0.6 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Metabolism and nutrition disorders
|
0.6 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Renal and urinary disorders
|
0.5 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Hepatobiliary disorders
|
0.4 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Blood and lymphatic system disorders
|
0.3 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Immune system disorders
|
0.1 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Investigations
|
0.1 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Skin and subcutaneous tissue disorders
|
0.1 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Congenital, familial and genetic disorders
|
0.1 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Endocrine disorders
|
0.1 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Eye disorders
|
0.1 Adverse events/100 participant-years
|
—
|
|
SAE Rates by System Organ Class (SOC) During the Study
Pregnancy, puerperium and perinatal conditions
|
0.1 Adverse events/100 participant-years
|
—
|
PRIMARY outcome
Timeframe: Up to Week 440Population: MITT Population
Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 1, Week 48, n= 246
|
0.2 Seconds
Standard Deviation 4.493
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 3, Week 48, n= 202
|
0.34 Seconds
Standard Deviation 3.77
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 5, Week 48, n= 172
|
0.5 Seconds
Standard Deviation 5.488
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 6, Week 24, n= 160
|
0.39 Seconds
Standard Deviation 3.333
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, 8 Week, Follow-Up, n= 104
|
3.3 Seconds
Standard Deviation 8.58
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 1, Week 4, n= 82
|
-0.05 Seconds
Standard Deviation 1.463
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 1, Week 12, n= 79
|
-0.66 Seconds
Standard Deviation 3.502
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 1, Week 24, n= 244
|
-0.04 Seconds
Standard Deviation 3.239
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 1, Week 36, n= 71
|
-0.42 Seconds
Standard Deviation 3.943
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 2, Week 24, n= 233
|
0.52 Seconds
Standard Deviation 5.059
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 2, Week 48, n= 221
|
0.24 Seconds
Standard Deviation 2.693
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 3, Week 24, n= 206
|
0.26 Seconds
Standard Deviation 2.983
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 4, Week 24, n= 201
|
0.39 Seconds
Standard Deviation 3.047
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 4, Week 48, n= 186
|
1.96 Seconds
Standard Deviation 14.36
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 5, Week 24, n= 174
|
0.6 Seconds
Standard Deviation 3.56
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 6, Week 48, n= 126
|
0.55 Seconds
Standard Deviation 3.473
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 7, Week 24, n= 118
|
0.72 Seconds
Standard Deviation 3.23
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 7, Week 48, n= 92
|
0.68 Seconds
Standard Deviation 5.149
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 8, Week 24, n= 58
|
0.5 Seconds
Standard Deviation 2.401
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 8, Week 48, n= 28
|
1.85 Seconds
Standard Deviation 4.759
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 9, Week 24, n= 2
|
1.45 Seconds
Standard Deviation 2.758
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Exit, n= 229
|
0.57 Seconds
Standard Deviation 3.972
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, 8 Week, Follow-Up, n= 103
|
0.33 Seconds
Standard Deviation 2.202
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 2, Week 48, n= 220
|
3.9 Seconds
Standard Deviation 5.39
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 1, Week 4, n= 82
|
1.3 Seconds
Standard Deviation 4.46
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 1, Week 12, n= 79
|
1 Seconds
Standard Deviation 4.56
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 1, Week 24, n= 243
|
0.7 Seconds
Standard Deviation 4.81
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 1, Week 36, n= 71
|
1.4 Seconds
Standard Deviation 4.83
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 1, Week 48, n= 246
|
1.7 Seconds
Standard Deviation 5.37
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 2, Week 24, n= 231
|
2.7 Seconds
Standard Deviation 5.88
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 3, Week 24, n= 206
|
4.5 Seconds
Standard Deviation 4.92
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 3, Week 48, n= 202
|
4 Seconds
Standard Deviation 5.34
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 4, Week 24, n= 201
|
4.2 Seconds
Standard Deviation 6.51
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 4, Week 48, n= 185
|
4.7 Seconds
Standard Deviation 8.19
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 5, Week 24, n= 174
|
4.7 Seconds
Standard Deviation 7.03
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 5, Week 48, n= 171
|
3.6 Seconds
Standard Deviation 5.46
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 6, Week 24, n= 160
|
4.3 Seconds
Standard Deviation 6.37
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 6, Week 48, n= 126
|
4.8 Seconds
Standard Deviation 7.71
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 7, Week 24, n= 118
|
4.4 Seconds
Standard Deviation 4.77
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 7, Week 48, n= 92
|
5 Seconds
Standard Deviation 9.55
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 8, Week 24, n= 59
|
4.7 Seconds
Standard Deviation 5.02
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 8, Week 48, n= 28
|
4.7 Seconds
Standard Deviation 5.51
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 9, Week 24, n= 2
|
8.5 Seconds
Standard Deviation 13.44
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Exit, n= 230
|
3.1 Seconds
Standard Deviation 6.72
|
—
|
PRIMARY outcome
Timeframe: Up to Week 440Population: MITT Population
Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils segmented and platelets is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 8, Week 24, n= 60
|
0.002 Billion cells per liter
Standard Deviation 0.0155
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 9, Week 24, n= 2
|
0.02 Billion cells per liter
Standard Deviation 0.0141
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 5, Week 48, n= 184
|
-0.019 Billion cells per liter
Standard Deviation 0.1547
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 6, Week 24, n= 176
|
-0.027 Billion cells per liter
Standard Deviation 0.1169
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 1, Week 36, n= 240
|
0.04 Billion cells per liter
Standard Deviation 2.092
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 2, Week 24, n= 250
|
-0.19 Billion cells per liter
Standard Deviation 2.087
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 6, Week 48, n= 132
|
-0.24 Billion cells per liter
Standard Deviation 2.164
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 7, Week 24, n= 122
|
-0.22 Billion cells per liter
Standard Deviation 2.149
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 8, Week 48, n= 29
|
-0.63 Billion cells per liter
Standard Deviation 2.549
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, 8 Week, Follow-Up, n= 106
|
-0.11 Billion cells per liter
Standard Deviation 2.613
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 1, Week 4, n= 257
|
0.076 Billion cells per liter
Standard Deviation 0.4223
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 6, Week 24, n= 176
|
-0.021 Billion cells per liter
Standard Deviation 0.5876
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 2, Week 48, n= 233
|
0.052 Billion cells per liter
Standard Deviation 0.1805
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 3, Week 48, n= 211
|
0.071 Billion cells per liter
Standard Deviation 0.1903
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 9, Week 24, n= 2
|
0.03 Billion cells per liter
Standard Deviation 0.3818
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Exit, n= 233
|
0.075 Billion cells per liter
Standard Deviation 0.1846
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, 8 Week, Follow-Up, n= 106
|
-0.214 Billion cells per liter
Standard Deviation 2.5793
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 3, Week 24, n= 219
|
-0.397 Billion cells per liter
Standard Deviation 1.8509
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 6, Week 24, n= 176
|
-0.422 Billion cells per liter
Standard Deviation 2.0826
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, 8 Week, Follow-Up, n= 106
|
-0.215 Billion cells per liter
Standard Deviation 2.5788
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 6, Week 48, n= 132
|
-0.038 Billion cells per liter
Standard Deviation 0.1227
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 7, Week 24, n= 122
|
-0.017 Billion cells per liter
Standard Deviation 0.1269
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 7, Week 48, n= 96
|
-0.026 Billion cells per liter
Standard Deviation 0.1401
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 8, Week 24, n= 60
|
-0.031 Billion cells per liter
Standard Deviation 0.1425
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 8, Week 48, n= 29
|
-0.032 Billion cells per liter
Standard Deviation 0.1121
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 9, Week 24, n= 2
|
-0.08 Billion cells per liter
Standard Deviation 0.0141
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Exit, n= 233
|
-0.026 Billion cells per liter
Standard Deviation 0.1295
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, 8 Week, Follow-Up, n= 106
|
-0.022 Billion cells per liter
Standard Deviation 0.1401
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 1, Week 4, n= 257
|
0.08 Billion cells per liter
Standard Deviation 1.642
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 1, Week 12, n= 249
|
0.18 Billion cells per liter
Standard Deviation 1.856
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 1, Week 24, n= 249
|
-0.02 Billion cells per liter
Standard Deviation 1.884
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 1, Week 48, n= 254
|
-0.01 Billion cells per liter
Standard Deviation 1.863
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 2, Week 48, n= 233
|
-0.27 Billion cells per liter
Standard Deviation 2.19
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 3, Week 24, n= 219
|
-0.33 Billion cells per liter
Standard Deviation 1.959
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 3, Week 48, n= 211
|
-0.42 Billion cells per liter
Standard Deviation 1.876
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 4, Week 24, n= 210
|
-0.29 Billion cells per liter
Standard Deviation 2.205
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 4, Week 48, n= 194
|
-0.35 Billion cells per liter
Standard Deviation 2.207
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 5, Week 24, n= 188
|
-0.4 Billion cells per liter
Standard Deviation 2.112
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 5, Week 48, n= 184
|
-0.18 Billion cells per liter
Standard Deviation 2.389
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 6, Week 24, n= 176
|
-0.4 Billion cells per liter
Standard Deviation 2.161
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 7, Week 48, n= 96
|
0.05 Billion cells per liter
Standard Deviation 2.388
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 8, Week 24, n= 60
|
0.17 Billion cells per liter
Standard Deviation 2.297
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Year 9, Week 24, n= 2
|
-3.7 Billion cells per liter
Standard Deviation 1.273
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Leukocytes, Exit, n= 233
|
0.09 Billion cells per liter
Standard Deviation 2.969
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 1, Week 12, n= 249
|
0.039 Billion cells per liter
Standard Deviation 0.558
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 1, Week 24, n= 249
|
0.002 Billion cells per liter
Standard Deviation 0.5023
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 1, Week 36, n= 240
|
0.059 Billion cells per liter
Standard Deviation 0.5002
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 1, Week 48, n= 254
|
-0.02 Billion cells per liter
Standard Deviation 0.5129
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 2, Week 24, n= 250
|
-0.073 Billion cells per liter
Standard Deviation 0.5033
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 2, Week 48, n= 233
|
-0.036 Billion cells per liter
Standard Deviation 0.5299
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 3, Week 24, n= 219
|
0.002 Billion cells per liter
Standard Deviation 0.5621
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 3, Week 48, n= 211
|
-0.028 Billion cells per liter
Standard Deviation 0.572
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 4, Week 24, n= 210
|
-0.036 Billion cells per liter
Standard Deviation 0.5809
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 4, Week 48, n= 194
|
-0.067 Billion cells per liter
Standard Deviation 0.5678
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 5, Week 24, n= 188
|
-0.07 Billion cells per liter
Standard Deviation 0.5924
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 5, Week 48, n= 184
|
-0.047 Billion cells per liter
Standard Deviation 0.629
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 6, Week 48, n= 132
|
-0.008 Billion cells per liter
Standard Deviation 0.5564
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 7, Week 24, n= 122
|
0.011 Billion cells per liter
Standard Deviation 0.6439
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 7, Week 48, n= 96
|
0.143 Billion cells per liter
Standard Deviation 0.6619
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 8, Week 24, n= 60
|
0.126 Billion cells per liter
Standard Deviation 0.6291
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 8, Week 48, n= 29
|
0.059 Billion cells per liter
Standard Deviation 0.8495
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 9, Week 24, n= 2
|
0.765 Billion cells per liter
Standard Deviation 1.4354
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Exit, n= 233
|
-0.025 Billion cells per liter
Standard Deviation 0.6129
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, 8 Week, Follow-Up, n= 106
|
0.029 Billion cells per liter
Standard Deviation 0.6256
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 1, Week 4, n= 257
|
0.028 Billion cells per liter
Standard Deviation 0.1673
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 1, Week 12, n= 249
|
0.036 Billion cells per liter
Standard Deviation 0.1694
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 1, Week 24, n= 249
|
0.024 Billion cells per liter
Standard Deviation 0.1678
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 1, Week 36, n= 240
|
0.054 Billion cells per liter
Standard Deviation 0.1806
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 1, Week 48, n= 254
|
0.044 Billion cells per liter
Standard Deviation 0.1754
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 2, Week 24, n= 250
|
0.053 Billion cells per liter
Standard Deviation 0.1809
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 3, Week 24, n= 219
|
0.059 Billion cells per liter
Standard Deviation 0.1809
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 4, Week 24, n= 210
|
0.065 Billion cells per liter
Standard Deviation 0.1875
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 4, Week 48, n= 194
|
0.084 Billion cells per liter
Standard Deviation 0.1782
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 5, Week 24, n= 188
|
0.095 Billion cells per liter
Standard Deviation 0.1878
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 5, Week 48, n= 184
|
0.086 Billion cells per liter
Standard Deviation 0.1983
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 6, Week 24, n= 176
|
0.072 Billion cells per liter
Standard Deviation 0.1826
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 6, Week 48, n= 132
|
0.049 Billion cells per liter
Standard Deviation 0.1808
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 7, Week 24, n= 122
|
0.098 Billion cells per liter
Standard Deviation 0.1996
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 7, Week 48, n= 96
|
0.097 Billion cells per liter
Standard Deviation 0.2032
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 8, Week 24, n= 60
|
0.101 Billion cells per liter
Standard Deviation 0.1909
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 8, Week 48, n= 29
|
0.024 Billion cells per liter
Standard Deviation 0.2074
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, 8 Week, Follow-Up, n= 106
|
0.093 Billion cells per liter
Standard Deviation 0.1958
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 1, Week 4, n= 257
|
-0.027 Billion cells per liter
Standard Deviation 1.6734
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 1, Week 4, n= 257
|
0.001 Billion cells per liter
Standard Deviation 0.0157
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 1, Week 12, n= 249
|
0.002 Billion cells per liter
Standard Deviation 0.0173
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 1, Week 24, n= 249
|
0.003 Billion cells per liter
Standard Deviation 0.0175
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 1, Week 36, n= 240
|
0.003 Billion cells per liter
Standard Deviation 0.0172
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 1, Week 48, n= 254
|
0.001 Billion cells per liter
Standard Deviation 0.016
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 2, Week 24, n= 250
|
0.002 Billion cells per liter
Standard Deviation 0.0159
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 2, Week 48, n= 233
|
0.001 Billion cells per liter
Standard Deviation 0.0157
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 3, Week 24, n= 219
|
0.004 Billion cells per liter
Standard Deviation 0.0156
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 3, Week 48, n= 211
|
0.004 Billion cells per liter
Standard Deviation 0.0179
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 4, Week 24, n= 210
|
0.004 Billion cells per liter
Standard Deviation 0.0157
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 4, Week 48, n= 194
|
0.002 Billion cells per liter
Standard Deviation 0.0159
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 5, Week 24, n= 188
|
0.003 Billion cells per liter
Standard Deviation 0.0168
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 5, Week 48, n= 184
|
0.005 Billion cells per liter
Standard Deviation 0.0226
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 6, Week 24, n= 176
|
0.003 Billion cells per liter
Standard Deviation 0.0149
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 6, Week 48, n= 132
|
0.003 Billion cells per liter
Standard Deviation 0.0178
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 7, Week 24, n= 122
|
0.005 Billion cells per liter
Standard Deviation 0.0189
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 7, Week 48, n= 96
|
0.009 Billion cells per liter
Standard Deviation 0.0188
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 8, Week 48, n= 29
|
0.002 Billion cells per liter
Standard Deviation 0.0147
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Exit, n= 233
|
0.005 Billion cells per liter
Standard Deviation 0.0183
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, 8 Week, Follow-Up, n= 106
|
0.004 Billion cells per liter
Standard Deviation 0.0186
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 1, Week 4, n= 257
|
-0.001 Billion cells per liter
Standard Deviation 0.0893
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 1, Week 12, n= 249
|
0.005 Billion cells per liter
Standard Deviation 0.1089
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 1, Week 24, n= 249
|
0.008 Billion cells per liter
Standard Deviation 0.1281
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 1, Week 36, n= 240
|
0.004 Billion cells per liter
Standard Deviation 0.1279
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 1, Week 48, n= 254
|
0.007 Billion cells per liter
Standard Deviation 0.1216
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 2, Week 24, n= 250
|
0.006 Billion cells per liter
Standard Deviation 0.1228
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 2, Week 48, n= 233
|
-0.009 Billion cells per liter
Standard Deviation 0.1234
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 3, Week 24, n= 219
|
-0.002 Billion cells per liter
Standard Deviation 0.1303
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 3, Week 48, n= 211
|
-0.023 Billion cells per liter
Standard Deviation 0.1276
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 4, Week 24, n= 210
|
-0.034 Billion cells per liter
Standard Deviation 0.125
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 4, Week 48, n= 194
|
-0.032 Billion cells per liter
Standard Deviation 0.1407
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 5, Week 24, n= 188
|
-0.038 Billion cells per liter
Standard Deviation 0.1281
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 1, Week 12, n= 249
|
0.1 Billion cells per liter
Standard Deviation 1.7293
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 1, Week 24, n= 249
|
-0.059 Billion cells per liter
Standard Deviation 1.8685
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 1, Week 36, n= 240
|
-0.086 Billion cells per liter
Standard Deviation 2.1086
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 1, Week 48, n= 254
|
-0.037 Billion cells per liter
Standard Deviation 1.7955
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 2, Week 24, n= 250
|
-0.176 Billion cells per liter
Standard Deviation 2.0209
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 2, Week 48, n= 233
|
-0.283 Billion cells per liter
Standard Deviation 2.1226
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 3, Week 24, n= 219
|
-0.397 Billion cells per liter
Standard Deviation 1.8521
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 3, Week 48, n= 211
|
-0.443 Billion cells per liter
Standard Deviation 1.763
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 4, Week 24, n= 210
|
-0.288 Billion cells per liter
Standard Deviation 2.1214
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 4, Week 48, n= 194
|
-0.342 Billion cells per liter
Standard Deviation 2.1425
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 5, Week 24, n= 188
|
-0.392 Billion cells per liter
Standard Deviation 1.9654
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 5, Week 48, n= 184
|
-0.207 Billion cells per liter
Standard Deviation 2.2312
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 6, Week 24, n= 176
|
-0.424 Billion cells per liter
Standard Deviation 2.0787
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 6, Week 48, n= 132
|
-0.251 Billion cells per liter
Standard Deviation 2.1415
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 7, Week 24, n= 122
|
-0.315 Billion cells per liter
Standard Deviation 2.1382
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 7, Week 48, n= 96
|
-0.176 Billion cells per liter
Standard Deviation 2.3755
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 8, Week 24, n= 60
|
-0.025 Billion cells per liter
Standard Deviation 2.2303
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 8, Week 48, n= 29
|
-0.681 Billion cells per liter
Standard Deviation 2.4214
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Year 9, Week 24, n= 2
|
-4.44 Billion cells per liter
Standard Deviation 0.5798
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils, Exit, n= 233
|
0.058 Billion cells per liter
Standard Deviation 2.9836
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 1, Week 4, n= 257
|
-0.028 Billion cells per liter
Standard Deviation 1.6685
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 1, Week 12, n= 249
|
0.098 Billion cells per liter
Standard Deviation 1.7212
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 1, Week 24, n= 249
|
-0.059 Billion cells per liter
Standard Deviation 1.8683
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 1, Week 36, n= 240
|
-0.086 Billion cells per liter
Standard Deviation 2.1097
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 1, Week 48, n= 254
|
-0.044 Billion cells per liter
Standard Deviation 1.8014
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 2, Week 24, n= 250
|
-0.177 Billion cells per liter
Standard Deviation 2.0163
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 2, Week 48, n= 233
|
-0.284 Billion cells per liter
Standard Deviation 2.1204
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 3, Week 48, n= 211
|
-0.444 Billion cells per liter
Standard Deviation 1.7607
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 4, Week 24, n= 210
|
-0.286 Billion cells per liter
Standard Deviation 2.1249
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 4, Week 48, n= 194
|
-0.342 Billion cells per liter
Standard Deviation 2.1464
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 5, Week 24, n= 188
|
-0.39 Billion cells per liter
Standard Deviation 1.9703
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 5, Week 48, n= 184
|
-0.207 Billion cells per liter
Standard Deviation 2.2273
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 6, Week 48, n= 132
|
-0.249 Billion cells per liter
Standard Deviation 2.1432
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 7, Week 24, n= 122
|
-0.313 Billion cells per liter
Standard Deviation 2.1378
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 7, Week 48, n= 96
|
-0.179 Billion cells per liter
Standard Deviation 2.3698
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 8, Week 24, n= 60
|
-0.025 Billion cells per liter
Standard Deviation 2.2303
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 8, Week 48, n= 29
|
-0.681 Billion cells per liter
Standard Deviation 2.4214
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 9, Week 24, n= 2
|
-4.44 Billion cells per liter
Standard Deviation 0.5798
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Exit, n= 233
|
0.046 Billion cells per liter
Standard Deviation 2.8796
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 1, Week 4, n= 254
|
2.9 Billion cells per liter
Standard Deviation 35.71
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 1, Week 12, n= 248
|
-1.1 Billion cells per liter
Standard Deviation 42.04
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 1, Week 24, n= 247
|
-2 Billion cells per liter
Standard Deviation 41.13
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 1, Week 36, n= 238
|
-5.9 Billion cells per liter
Standard Deviation 46.11
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 1, Week 48, n= 252
|
-8.4 Billion cells per liter
Standard Deviation 46.36
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 2, Week 24, n= 249
|
-17.5 Billion cells per liter
Standard Deviation 56.18
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 2, Week 48, n= 233
|
-18.8 Billion cells per liter
Standard Deviation 56.8
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 3, Week 24, n= 218
|
-17 Billion cells per liter
Standard Deviation 56.86
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 3, Week 48, n= 210
|
-22.4 Billion cells per liter
Standard Deviation 57.11
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 4, Week 24, n= 210
|
-14.6 Billion cells per liter
Standard Deviation 64.11
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 4, Week 48, n= 193
|
-17 Billion cells per liter
Standard Deviation 60.26
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 5, Week 24, n= 188
|
-19 Billion cells per liter
Standard Deviation 65.99
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 5, Week 48, n= 184
|
-17.6 Billion cells per liter
Standard Deviation 65.69
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 6, Week 24, n= 175
|
-18.9 Billion cells per liter
Standard Deviation 62.88
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 6, Week 48, n= 132
|
-23.7 Billion cells per liter
Standard Deviation 67.73
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 7, Week 24, n= 121
|
-14 Billion cells per liter
Standard Deviation 77.75
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 7, Week 48, n= 96
|
-24.7 Billion cells per liter
Standard Deviation 64.56
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 8, Week 24, n= 60
|
-30.5 Billion cells per liter
Standard Deviation 65.89
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 8, Week 48, n= 29
|
-40.7 Billion cells per liter
Standard Deviation 62.84
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 9, Week 24, n= 2
|
37 Billion cells per liter
Standard Deviation 83.44
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Exit, n= 233
|
-9.4 Billion cells per liter
Standard Deviation 59.82
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, 8 Week, Follow-Up, n= 106
|
-8 Billion cells per liter
Standard Deviation 70.29
|
—
|
PRIMARY outcome
Timeframe: Up to Week 440Population: MITT Population
Hematology parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 1, Week 36, n= 240
|
0.03 Trillions cells per liter
Standard Deviation 0.309
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 5, Week 48, n= 184
|
0.1 Trillions cells per liter
Standard Deviation 0.412
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 1, Week 4, n= 257
|
0 Trillions cells per liter
Standard Deviation 0.243
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 1, Week 12, n= 249
|
0.01 Trillions cells per liter
Standard Deviation 0.284
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 1, Week 24, n= 250
|
0.04 Trillions cells per liter
Standard Deviation 0.291
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 1, Week 48, n= 254
|
0.06 Trillions cells per liter
Standard Deviation 0.337
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 2, Week 24, n= 249
|
0.06 Trillions cells per liter
Standard Deviation 0.341
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 2, Week 48, n= 233
|
0.04 Trillions cells per liter
Standard Deviation 0.338
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 3, Week 24, n= 219
|
0.06 Trillions cells per liter
Standard Deviation 0.361
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 3, Week 48, n= 211
|
0.04 Trillions cells per liter
Standard Deviation 0.362
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 4, Week 24, n= 210
|
0.03 Trillions cells per liter
Standard Deviation 0.37
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 4, Week 48, n= 194
|
0.07 Trillions cells per liter
Standard Deviation 0.376
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 5, Week 24, n= 189
|
0.08 Trillions cells per liter
Standard Deviation 0.395
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 6, Week 24, n= 176
|
0.13 Trillions cells per liter
Standard Deviation 0.405
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 6, Week 48, n= 132
|
0.19 Trillions cells per liter
Standard Deviation 0.393
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 7, Week 24, n= 122
|
0.2 Trillions cells per liter
Standard Deviation 0.438
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 7, Week 48, n= 96
|
0.19 Trillions cells per liter
Standard Deviation 0.441
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 8, Week 24, n= 60
|
0.25 Trillions cells per liter
Standard Deviation 0.404
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 8, Week 48, n= 29
|
0.39 Trillions cells per liter
Standard Deviation 0.403
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 9, Week 24, n= 2
|
0.1 Trillions cells per liter
Standard Deviation 0
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Exit, n= 233
|
0.26 Trillions cells per liter
Standard Deviation 0.398
|
—
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, 8 Week, Follow-Up, n= 106
|
0.2 Trillions cells per liter
Standard Deviation 0.415
|
—
|
PRIMARY outcome
Timeframe: Up to Week 440Population: MITT Population
Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 1, Week 4, n= 257
|
0.16 Percentage
Standard Deviation 2.247
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 1, Week 12, n= 249
|
0.11 Percentage
Standard Deviation 2.62
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 1, Week 24, n= 250
|
0.31 Percentage
Standard Deviation 2.683
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 1, Week 36, n= 240
|
0.2 Percentage
Standard Deviation 2.836
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 1, Week 48, n= 254
|
0.73 Percentage
Standard Deviation 3.087
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 2, Week 24, n= 249
|
0.81 Percentage
Standard Deviation 3.321
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 2, Week 48, n= 233
|
1.09 Percentage
Standard Deviation 3.433
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 3, Week 24, n= 219
|
1.4 Percentage
Standard Deviation 3.604
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 3, Week 48, n= 211
|
1.53 Percentage
Standard Deviation 3.545
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 4, Week 24, n= 210
|
1.39 Percentage
Standard Deviation 3.448
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 4, Week 48, n= 194
|
1.67 Percentage
Standard Deviation 3.414
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 5, Week 24, n= 189
|
1.78 Percentage
Standard Deviation 3.596
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 5, Week 48, n= 184
|
1.98 Percentage
Standard Deviation 3.943
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 6, Week 24, n= 176
|
2.16 Percentage
Standard Deviation 3.94
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 6, Week 48, n= 132
|
2.49 Percentage
Standard Deviation 3.561
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 7, Week 24, n= 122
|
2.34 Percentage
Standard Deviation 4.166
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 7, Week 48, n= 96
|
1.86 Percentage
Standard Deviation 4.108
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 8, Week 24, n= 60
|
2.68 Percentage
Standard Deviation 3.807
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 8, Week 48, n= 29
|
3.49 Percentage
Standard Deviation 3.554
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 9, Week 24, n= 2
|
0.7 Percentage
Standard Deviation 0.99
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Exit, n= 233
|
3.25 Percentage
Standard Deviation 3.613
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, 8 Week, Follow-Up, n= 106
|
3.04 Percentage
Standard Deviation 3.478
|
—
|
PRIMARY outcome
Timeframe: Up to Week 440Population: MITT Population
Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 1, Week 4, n= 257
|
0 Grams per liter
Standard Deviation 7.03
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 1, Week 12, n= 249
|
0.3 Grams per liter
Standard Deviation 8.17
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 1, Week 24, n= 250
|
0.5 Grams per liter
Standard Deviation 8.81
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 1, Week 36, n= 240
|
0.5 Grams per liter
Standard Deviation 9.51
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 1, Week 48, n= 254
|
2.1 Grams per liter
Standard Deviation 10.2
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 2, Week 24, n= 250
|
2.5 Grams per liter
Standard Deviation 11.07
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 2, Week 48, n= 233
|
2.4 Grams per liter
Standard Deviation 11.76
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 3, Week 24, n= 219
|
3.7 Grams per liter
Standard Deviation 11.93
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 3, Week 48, n= 211
|
3.9 Grams per liter
Standard Deviation 11.86
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 4, Week 24, n= 210
|
2.5 Grams per liter
Standard Deviation 11.91
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 4, Week 48, n= 194
|
3.2 Grams per liter
Standard Deviation 11.82
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 5, Week 24, n= 189
|
3.7 Grams per liter
Standard Deviation 12.44
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 5, Week 48, n= 184
|
3.7 Grams per liter
Standard Deviation 13.71
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 6, Week 24, n= 176
|
3.7 Grams per liter
Standard Deviation 13.6
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 6, Week 48, n= 132
|
4.2 Grams per liter
Standard Deviation 13.13
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 7, Week 24, n= 122
|
3.3 Grams per liter
Standard Deviation 14.73
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 7, Week 48, n= 96
|
2.6 Grams per liter
Standard Deviation 14.98
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 8, Week 24, n= 60
|
5.2 Grams per liter
Standard Deviation 12.78
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 8, Week 48, n= 29
|
8.4 Grams per liter
Standard Deviation 12.98
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 9, Week 24, n= 2
|
-3 Grams per liter
Standard Deviation 2.83
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Exit, n= 233
|
7.2 Grams per liter
Standard Deviation 12.46
|
—
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, 8 Week, Follow-Up, n= 106
|
6.5 Grams per liter
Standard Deviation 11.93
|
—
|
PRIMARY outcome
Timeframe: Up to Week 440Population: MITT Population
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 4, Week 48, n= 194
|
1.5 Grams per liter
Standard Deviation 3.5
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 7, Week 48, n= 97
|
1.6 Grams per liter
Standard Deviation 4.19
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Exit, n= 235
|
2.2 Grams per liter
Standard Deviation 3.59
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 4, Week 24, n= 207
|
-3.4 Grams per liter
Standard Deviation 5.3
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Exit, n= 235
|
-2.6 Grams per liter
Standard Deviation 5.53
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 5, Week 48, n= 178
|
-3.4 Grams per liter
Standard Deviation 5.16
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 6, Week 24, n= 175
|
-4 Grams per liter
Standard Deviation 5.55
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 6, Week 48, n= 134
|
-3.5 Grams per liter
Standard Deviation 5.81
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 1, Week 4, n= 251
|
-0.3 Grams per liter
Standard Deviation 2.17
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 1, Week 12, n= 248
|
0.1 Grams per liter
Standard Deviation 2.53
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 1, Week 24, n= 246
|
0.3 Grams per liter
Standard Deviation 2.47
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 1, Week 36, n= 238
|
0.4 Grams per liter
Standard Deviation 2.69
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 1, Week 48, n= 250
|
1.1 Grams per liter
Standard Deviation 2.88
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 2, Week 24, n= 248
|
1.1 Grams per liter
Standard Deviation 3.18
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 2, Week 48, n= 233
|
1.2 Grams per liter
Standard Deviation 3.25
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 3, Week 24, n= 218
|
1.3 Grams per liter
Standard Deviation 3.41
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 3, Week 48, n= 209
|
1.4 Grams per liter
Standard Deviation 3.65
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 4, Week 24, n= 207
|
1.3 Grams per liter
Standard Deviation 3.6
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 5, Week 24, n= 184
|
1.7 Grams per liter
Standard Deviation 3.76
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 5, Week 48, n= 178
|
2 Grams per liter
Standard Deviation 3.69
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 6, Week 24, n= 175
|
1.8 Grams per liter
Standard Deviation 4.05
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 6, Week 48, n= 134
|
1.8 Grams per liter
Standard Deviation 4.09
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 7, Week 24, n= 123
|
1.4 Grams per liter
Standard Deviation 4.14
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 8, Week 24, n= 60
|
2 Grams per liter
Standard Deviation 4.4
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 8, Week 48, n= 28
|
2.9 Grams per liter
Standard Deviation 3.92
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 9, Week 24, n= 2
|
1 Grams per liter
Standard Deviation 0
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, 8 Week, Follow-Up, n= 107
|
1.8 Grams per liter
Standard Deviation 3.77
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 1, Week 4, n= 251
|
-1.3 Grams per liter
Standard Deviation 3.73
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 1, Week 12, n= 248
|
-1.9 Grams per liter
Standard Deviation 4.41
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 1, Week 24, n= 246
|
-2.1 Grams per liter
Standard Deviation 4.31
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 1, Week 36, n= 238
|
-2.6 Grams per liter
Standard Deviation 4.59
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 1, Week 48, n= 250
|
-1.8 Grams per liter
Standard Deviation 4.91
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 2, Week 24, n= 248
|
-2.2 Grams per liter
Standard Deviation 4.9
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 2, Week 48, n= 233
|
-2.6 Grams per liter
Standard Deviation 5.08
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 3, Week 24, n= 218
|
-2.6 Grams per liter
Standard Deviation 5
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 3, Week 48, n= 209
|
-3 Grams per liter
Standard Deviation 5.36
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 4, Week 48, n= 194
|
-3.6 Grams per liter
Standard Deviation 5.22
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 5, Week 24, n= 184
|
-3.4 Grams per liter
Standard Deviation 5.44
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 7, Week 24, n= 123
|
-4.3 Grams per liter
Standard Deviation 5.56
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 7, Week 48, n= 97
|
-4.3 Grams per liter
Standard Deviation 5.87
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 8, Week 24, n= 60
|
-4.1 Grams per liter
Standard Deviation 5.78
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 8, Week 48, n= 28
|
-3 Grams per liter
Standard Deviation 5.18
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 9, Week 24, n= 2
|
-1.5 Grams per liter
Standard Deviation 2.12
|
—
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, 8 Week, Follow-Up, n= 107
|
-3.1 Grams per liter
Standard Deviation 6.19
|
—
|
PRIMARY outcome
Timeframe: Up to Week 440Population: MITT Population
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in blood urea nitrogen, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 1, Week 4, n= 251
|
0.1088 Millimoles per liter
Standard Deviation 1.1734
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Exit, n= 235
|
0.2986 Millimoles per liter
Standard Deviation 1.3871
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, 8 Week, Follow-Up, n= 107
|
0.3354 Millimoles per liter
Standard Deviation 1.4114
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 1, Week 4, n= 242
|
0.0071 Millimoles per liter
Standard Deviation 0.0888
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 1, Week 12, n= 247
|
-0.0043 Millimoles per liter
Standard Deviation 0.0872
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 1, Week 24, n= 244
|
-0.0023 Millimoles per liter
Standard Deviation 0.0889
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 1, Week 48, n= 250
|
0.0007 Millimoles per liter
Standard Deviation 0.0896
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 2, Week 24, n= 246
|
-0.0017 Millimoles per liter
Standard Deviation 0.0946
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 2, Week 48, n= 231
|
-0.0019 Millimoles per liter
Standard Deviation 0.0922
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 3, Week 48, n= 205
|
-0.0109 Millimoles per liter
Standard Deviation 0.1004
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 4, Week 24, n= 204
|
-0.0115 Millimoles per liter
Standard Deviation 0.095
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 4, Week 48, n= 191
|
-0.0072 Millimoles per liter
Standard Deviation 0.0889
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 5, Week 24, n= 184
|
-0.0181 Millimoles per liter
Standard Deviation 0.0986
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 5, Week 48, n= 176
|
-0.0011 Millimoles per liter
Standard Deviation 0.0912
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 6, Week 24, n= 172
|
-0.0107 Millimoles per liter
Standard Deviation 0.0977
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 6, Week 48, n= 134
|
0.0007 Millimoles per liter
Standard Deviation 0.0925
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 8, Week 24, n= 60
|
-0.0123 Millimoles per liter
Standard Deviation 0.0788
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 8, Week 48, n= 28
|
0.0021 Millimoles per liter
Standard Deviation 0.0935
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 9, Week 24, n= 2
|
-0.005 Millimoles per liter
Standard Deviation 0.0354
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, 8 Week, Follow-Up, n= 107
|
0.0046 Millimoles per liter
Standard Deviation 0.1029
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 1, Week 4, n= 243
|
-0.2 Millimoles per liter
Standard Deviation 2.72
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 1, Week 12, n= 245
|
-0.4 Millimoles per liter
Standard Deviation 2.62
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 1, Week 24, n= 244
|
-0.2 Millimoles per liter
Standard Deviation 2.51
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 1, Week 36, n= 234
|
-0.1 Millimoles per liter
Standard Deviation 2.67
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 1, Week 48, n= 250
|
-0.2 Millimoles per liter
Standard Deviation 2.64
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 2, Week 24, n= 246
|
0 Millimoles per liter
Standard Deviation 2.58
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 2, Week 48, n= 231
|
-0.5 Millimoles per liter
Standard Deviation 2.78
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 3, Week 48, n= 205
|
-0.9 Millimoles per liter
Standard Deviation 2.82
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 4, Week 24, n= 204
|
-0.6 Millimoles per liter
Standard Deviation 2.7
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 4, Week 48, n= 191
|
-0.6 Millimoles per liter
Standard Deviation 2.79
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 5, Week 24, n= 184
|
-0.9 Millimoles per liter
Standard Deviation 2.68
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 6, Week 24, n= 172
|
-0.8 Millimoles per liter
Standard Deviation 2.62
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 6, Week 48, n= 134
|
-0.7 Millimoles per liter
Standard Deviation 3.23
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 7, Week 48, n= 97
|
-0.3 Millimoles per liter
Standard Deviation 3.14
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 8, Week 24, n= 60
|
-0.5 Millimoles per liter
Standard Deviation 3.17
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 8, Week 48, n= 28
|
-0.7 Millimoles per liter
Standard Deviation 2.87
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 9, Week 24, n= 2
|
-1 Millimoles per liter
Standard Deviation 1.41
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Exit, n= 235
|
0.1 Millimoles per liter
Standard Deviation 2.74
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, 8 Week, Follow-Up, n= 107
|
0 Millimoles per liter
Standard Deviation 2.55
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 1, Week 4, n= 251
|
0.2 Millimoles per liter
Standard Deviation 2.8
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 1, Week 12, n= 248
|
0.1 Millimoles per liter
Standard Deviation 2.53
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 1, Week 36, n= 238
|
0.5 Millimoles per liter
Standard Deviation 2.43
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 1, Week 48, n= 250
|
0 Millimoles per liter
Standard Deviation 2.53
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 2, Week 48, n= 233
|
0.1 Millimoles per liter
Standard Deviation 3.03
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 3, Week 24, n= 218
|
-0.1 Millimoles per liter
Standard Deviation 3.01
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 4, Week 24, n= 207
|
-0.4 Millimoles per liter
Standard Deviation 3.28
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 5, Week 24, n= 184
|
-0.3 Millimoles per liter
Standard Deviation 3.06
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 6, Week 24, n= 175
|
0 Millimoles per liter
Standard Deviation 3.11
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 6, Week 48, n= 134
|
0.3 Millimoles per liter
Standard Deviation 2.89
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 8, Week 24, n= 60
|
0.5 Millimoles per liter
Standard Deviation 3.21
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 8, Week 48, n= 28
|
1.1 Millimoles per liter
Standard Deviation 2.49
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 9, Week 24, n= 2
|
1.5 Millimoles per liter
Standard Deviation 2.12
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Exit, n= 235
|
-0.5 Millimoles per liter
Standard Deviation 2.96
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, 8 Week, Follow-Up, n= 107
|
0.1 Millimoles per liter
Standard Deviation 2.65
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 1, Week 4, n= 251
|
0.002 Millimoles per liter
Standard Deviation 0.0673
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 1, Week 12, n= 248
|
-0.005 Millimoles per liter
Standard Deviation 0.0625
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 1, Week 24, n= 246
|
0.004 Millimoles per liter
Standard Deviation 0.0599
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 1, Week 36, n= 238
|
0.001 Millimoles per liter
Standard Deviation 0.066
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 1, Week 48, n= 250
|
0.001 Millimoles per liter
Standard Deviation 0.0677
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 2, Week 24, n= 248
|
0.003 Millimoles per liter
Standard Deviation 0.0709
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 2, Week 48, n= 233
|
0.003 Millimoles per liter
Standard Deviation 0.0699
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 3, Week 24, n= 218
|
0.007 Millimoles per liter
Standard Deviation 0.0719
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 4, Week 24, n= 207
|
0.009 Millimoles per liter
Standard Deviation 0.0682
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 4, Week 48, n= 194
|
0.012 Millimoles per liter
Standard Deviation 0.0692
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 5, Week 24, n= 184
|
0.017 Millimoles per liter
Standard Deviation 0.062
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 5, Week 48, n= 178
|
0.014 Millimoles per liter
Standard Deviation 0.0622
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 6, Week 24, n= 175
|
0.017 Millimoles per liter
Standard Deviation 0.067
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 7, Week 24, n= 123
|
0.004 Millimoles per liter
Standard Deviation 0.0691
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 7, Week 48, n= 97
|
0.001 Millimoles per liter
Standard Deviation 0.0681
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 8, Week 24, n= 60
|
-0.006 Millimoles per liter
Standard Deviation 0.0644
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 8, Week 48, n= 28
|
0.016 Millimoles per liter
Standard Deviation 0.0599
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 9, Week 24, n= 2
|
0.02 Millimoles per liter
Standard Deviation 0.0283
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, 8 Week, Follow-Up, n= 107
|
0.028 Millimoles per liter
Standard Deviation 0.0728
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 1, Week 4, n= 251
|
0.0165 Millimoles per liter
Standard Deviation 0.1857
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 1, Week 12, n= 248
|
-0.0065 Millimoles per liter
Standard Deviation 0.1851
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 1, Week 36, n= 238
|
-0.0039 Millimoles per liter
Standard Deviation 0.1825
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 1, Week 48, n= 250
|
0.0019 Millimoles per liter
Standard Deviation 0.1926
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 2, Week 24, n= 248
|
-0.0133 Millimoles per liter
Standard Deviation 0.2219
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 2, Week 48, n= 233
|
0.0099 Millimoles per liter
Standard Deviation 0.1968
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 3, Week 48, n= 209
|
0.0017 Millimoles per liter
Standard Deviation 0.221
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 4, Week 24, n= 207
|
-0.0022 Millimoles per liter
Standard Deviation 0.2145
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 4, Week 48, n= 194
|
-0.0102 Millimoles per liter
Standard Deviation 0.1765
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 5, Week 24, n= 184
|
-0.015 Millimoles per liter
Standard Deviation 0.1899
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 5, Week 48, n= 178
|
-0.0035 Millimoles per liter
Standard Deviation 0.1892
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 6, Week 24, n= 175
|
-0.004 Millimoles per liter
Standard Deviation 0.2153
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 6, Week 48, n= 134
|
-0.0139 Millimoles per liter
Standard Deviation 0.2097
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 7, Week 48, n= 97
|
0.031 Millimoles per liter
Standard Deviation 0.1875
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 8, Week 24, n= 60
|
-0.0223 Millimoles per liter
Standard Deviation 0.2186
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 8, Week 48, n= 28
|
-0.0054 Millimoles per liter
Standard Deviation 0.2093
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Exit, n= 235
|
0.0161 Millimoles per liter
Standard Deviation 0.2151
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, 8 Week, Follow-Up, n= 107
|
0.0438 Millimoles per liter
Standard Deviation 0.2131
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 1, Week 4, n= 242
|
0.07 Millimoles per liter
Standard Deviation 0.407
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 1, Week 36, n= 234
|
0.03 Millimoles per liter
Standard Deviation 0.427
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 2, Week 24, n= 246
|
0.01 Millimoles per liter
Standard Deviation 0.42
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 2, Week 48, n= 231
|
0.02 Millimoles per liter
Standard Deviation 0.426
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 3, Week 24, n= 215
|
0.01 Millimoles per liter
Standard Deviation 0.418
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 3, Week 48, n= 205
|
0.01 Millimoles per liter
Standard Deviation 0.466
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 4, Week 24, n= 204
|
-0.02 Millimoles per liter
Standard Deviation 0.409
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 4, Week 48, n= 191
|
0.04 Millimoles per liter
Standard Deviation 0.417
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 5, Week 24, n= 184
|
0 Millimoles per liter
Standard Deviation 0.406
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 5, Week 48, n= 176
|
0.06 Millimoles per liter
Standard Deviation 0.427
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 6, Week 48, n= 134
|
0.06 Millimoles per liter
Standard Deviation 0.438
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 7, Week 48, n= 97
|
0.06 Millimoles per liter
Standard Deviation 0.387
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 8, Week 24, n= 60
|
0 Millimoles per liter
Standard Deviation 0.354
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 8, Week 48, n= 28
|
0.1 Millimoles per liter
Standard Deviation 0.401
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 9, Week 24, n= 2
|
0.05 Millimoles per liter
Standard Deviation 0.212
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Exit, n= 235
|
0.11 Millimoles per liter
Standard Deviation 0.431
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, 8 Week, Follow-Up, n= 107
|
0.07 Millimoles per liter
Standard Deviation 0.493
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 1, Week 4, n= 251
|
0.4 Millimoles per liter
Standard Deviation 2.67
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 1, Week 12, n= 248
|
0 Millimoles per liter
Standard Deviation 2.67
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 1, Week 24, n= 246
|
0.3 Millimoles per liter
Standard Deviation 2.02
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 1, Week 36, n= 238
|
0.3 Millimoles per liter
Standard Deviation 2.46
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 1, Week 48, n= 250
|
-0.1 Millimoles per liter
Standard Deviation 2.06
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 2, Week 24, n= 248
|
0 Millimoles per liter
Standard Deviation 2.19
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 2, Week 48, n= 233
|
0 Millimoles per liter
Standard Deviation 2.58
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 3, Week 24, n= 218
|
-0.1 Millimoles per liter
Standard Deviation 2.18
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 3, Week 48, n= 209
|
0.4 Millimoles per liter
Standard Deviation 2.44
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 4, Week 24, n= 207
|
0.2 Millimoles per liter
Standard Deviation 2.54
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 5, Week 24, n= 184
|
0.1 Millimoles per liter
Standard Deviation 2.19
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 5, Week 48, n= 178
|
0 Millimoles per liter
Standard Deviation 2.37
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 6, Week 24, n= 175
|
0.1 Millimoles per liter
Standard Deviation 2.33
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 6, Week 48, n= 134
|
0.3 Millimoles per liter
Standard Deviation 2.72
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 7, Week 24, n= 123
|
0.3 Millimoles per liter
Standard Deviation 2.97
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 7, Week 48, n= 97
|
0.3 Millimoles per liter
Standard Deviation 2.49
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 8, Week 24, n= 60
|
0.2 Millimoles per liter
Standard Deviation 2.32
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 8, Week 48, n= 28
|
0.4 Millimoles per liter
Standard Deviation 1.95
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Exit, n= 235
|
0.1 Millimoles per liter
Standard Deviation 2.32
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, 8 Week, Follow-Up, n= 107
|
0.8 Millimoles per liter
Standard Deviation 2.33
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 7, Week 48, n= 97
|
0.5 Millimoles per liter
Standard Deviation 3.28
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 3, Week 48, n= 209
|
0.011 Millimoles per liter
Standard Deviation 0.0681
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 6, Week 48, n= 134
|
0.003 Millimoles per liter
Standard Deviation 0.0664
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Exit, n= 235
|
0.03 Millimoles per liter
Standard Deviation 0.0676
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 1, Week 24, n= 246
|
0.0106 Millimoles per liter
Standard Deviation 0.2027
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 3, Week 24, n= 218
|
0.0033 Millimoles per liter
Standard Deviation 0.2129
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 7, Week 24, n= 123
|
0.0296 Millimoles per liter
Standard Deviation 0.1962
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 9, Week 24, n= 2
|
0.1467 Millimoles per liter
Standard Deviation 0.1893
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 1, Week 12, n= 245
|
0.02 Millimoles per liter
Standard Deviation 0.412
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 1, Week 24, n= 244
|
0.02 Millimoles per liter
Standard Deviation 0.409
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 1, Week 48, n= 250
|
-0.04 Millimoles per liter
Standard Deviation 0.413
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 6, Week 24, n= 172
|
-0.03 Millimoles per liter
Standard Deviation 0.431
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 7, Week 24, n= 121
|
0.04 Millimoles per liter
Standard Deviation 0.379
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 4, Week 48, n= 194
|
0.1 Millimoles per liter
Standard Deviation 2.36
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 9, Week 24, n= 2
|
-1 Millimoles per liter
Standard Deviation 1.41
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 1, Week 4, n= 251
|
0.026 Millimoles per liter
Standard Deviation 1.4283
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 1, Week 12, n= 248
|
-0.1695 Millimoles per liter
Standard Deviation 1.4782
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 1, Week 24, n= 246
|
-0.1612 Millimoles per liter
Standard Deviation 1.9011
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 1, Week 36, n= 238
|
-0.1732 Millimoles per liter
Standard Deviation 1.5648
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 1, Week 48, n= 250
|
-0.1013 Millimoles per liter
Standard Deviation 1.5557
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 2, Week 24, n= 248
|
-0.1873 Millimoles per liter
Standard Deviation 1.6796
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 2, Week 48, n= 233
|
-0.0134 Millimoles per liter
Standard Deviation 1.7024
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 3, Week 24, n= 218
|
-0.0552 Millimoles per liter
Standard Deviation 1.7117
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 3, Week 48, n= 209
|
-0.0472 Millimoles per liter
Standard Deviation 1.6693
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 4, Week 24, n= 207
|
-0.09 Millimoles per liter
Standard Deviation 1.6775
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 4, Week 48, n= 194
|
-0.1162 Millimoles per liter
Standard Deviation 1.721
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 5, Week 24, n= 184
|
-0.0331 Millimoles per liter
Standard Deviation 1.6526
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 5, Week 48, n= 178
|
0.0176 Millimoles per liter
Standard Deviation 1.7712
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 6, Week 24, n= 175
|
-0.0029 Millimoles per liter
Standard Deviation 1.6054
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 6, Week 48, n= 134
|
-0.0858 Millimoles per liter
Standard Deviation 1.6972
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 7, Week 24, n= 123
|
0.0246 Millimoles per liter
Standard Deviation 1.6668
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 7, Week 48, n= 97
|
-0.008 Millimoles per liter
Standard Deviation 1.6683
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 8, Week 24, n= 60
|
-0.1152 Millimoles per liter
Standard Deviation 1.5362
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 8, Week 48, n= 28
|
-0.1603 Millimoles per liter
Standard Deviation 1.5417
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Year 9, Week 24, n= 2
|
-0.1805 Millimoles per liter
Standard Deviation 1.06
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, Exit, n= 235
|
0.0501 Millimoles per liter
Standard Deviation 1.7369
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Blood urea nitrogen, 8 Week, Follow-Up, n= 107
|
0.3248 Millimoles per liter
Standard Deviation 2.2109
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 1, Week 12, n= 248
|
0.2006 Millimoles per liter
Standard Deviation 1.1712
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 1, Week 24, n= 246
|
0.0881 Millimoles per liter
Standard Deviation 1.2279
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 1, Week 36, n= 238
|
0.2158 Millimoles per liter
Standard Deviation 1.2519
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 1, Week 48, n= 250
|
0.1482 Millimoles per liter
Standard Deviation 1.5029
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 2, Week 24, n= 248
|
0.1146 Millimoles per liter
Standard Deviation 1.3072
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 2, Week 48, n= 233
|
0.323 Millimoles per liter
Standard Deviation 1.5426
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 3, Week 24, n= 218
|
0.1927 Millimoles per liter
Standard Deviation 1.4319
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 3, Week 48, n= 209
|
0.1719 Millimoles per liter
Standard Deviation 1.4829
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 4, Week 24, n= 207
|
0.2737 Millimoles per liter
Standard Deviation 1.6169
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 4, Week 48, n= 194
|
0.2523 Millimoles per liter
Standard Deviation 2.1698
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 5, Week 24, n= 184
|
0.2579 Millimoles per liter
Standard Deviation 1.4792
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 5, Week 48, n= 178
|
0.2964 Millimoles per liter
Standard Deviation 1.7205
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 6, Week 24, n= 175
|
0.2903 Millimoles per liter
Standard Deviation 1.7746
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 6, Week 48, n= 134
|
0.3897 Millimoles per liter
Standard Deviation 1.7503
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 7, Week 24, n= 123
|
0.297 Millimoles per liter
Standard Deviation 2.257
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 7, Week 48, n= 97
|
0.5098 Millimoles per liter
Standard Deviation 1.8839
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 8, Week 24, n= 60
|
0.449 Millimoles per liter
Standard Deviation 1.9609
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 8, Week 48, n= 28
|
0.7571 Millimoles per liter
Standard Deviation 2.2408
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 9, Week 24, n= 2
|
0.8845 Millimoles per liter
Standard Deviation 0.4094
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 1, Week 36, n= 235
|
-0.0156 Millimoles per liter
Standard Deviation 0.0884
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 3, Week 24, n= 214
|
-0.0009 Millimoles per liter
Standard Deviation 0.09
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 7, Week 24, n= 121
|
0.0014 Millimoles per liter
Standard Deviation 0.0873
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 7, Week 48, n= 97
|
0.0063 Millimoles per liter
Standard Deviation 0.0964
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Exit, n= 235
|
0.0151 Millimoles per liter
Standard Deviation 0.0923
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 3, Week 24, n= 215
|
-0.5 Millimoles per liter
Standard Deviation 2.75
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 5, Week 48, n= 176
|
-0.7 Millimoles per liter
Standard Deviation 2.73
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 7, Week 24, n= 121
|
-0.7 Millimoles per liter
Standard Deviation 2.84
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 1, Week 24, n= 246
|
0.3 Millimoles per liter
Standard Deviation 2.31
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 2, Week 24, n= 248
|
0.1 Millimoles per liter
Standard Deviation 2.6
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 3, Week 48, n= 209
|
0.1 Millimoles per liter
Standard Deviation 3.06
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 4, Week 48, n= 194
|
-0.3 Millimoles per liter
Standard Deviation 2.83
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 5, Week 48, n= 178
|
-0.1 Millimoles per liter
Standard Deviation 3.02
|
—
|
|
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 7, Week 24, n= 123
|
0.4 Millimoles per liter
Standard Deviation 3.1
|
—
|
PRIMARY outcome
Timeframe: Up to Week 440Population: MITT Population
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in urate, creatinine and bilirubin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 1, Week 4, n= 250
|
-0.2 Micromoles per liter
Standard Deviation 4.69
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 1, Week 12, n= 248
|
-0.5 Micromoles per liter
Standard Deviation 4.86
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 1, Week 24, n= 246
|
-0.6 Micromoles per liter
Standard Deviation 5.31
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 1, Week 36, n= 237
|
-0.4 Micromoles per liter
Standard Deviation 5.07
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 1, Week 48, n= 250
|
-0.2 Micromoles per liter
Standard Deviation 5.29
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 2, Week 48, n= 233
|
0.3 Micromoles per liter
Standard Deviation 4.78
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 3, Week 24, n= 218
|
0.8 Micromoles per liter
Standard Deviation 5.63
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 3, Week 48, n= 209
|
0.9 Micromoles per liter
Standard Deviation 5.61
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 4, Week 24, n= 207
|
1.2 Micromoles per liter
Standard Deviation 5.86
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 4, Week 48, n= 194
|
0.9 Micromoles per liter
Standard Deviation 6.05
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 5, Week 24, n= 184
|
1 Micromoles per liter
Standard Deviation 5.52
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 5, Week 48, n= 178
|
1.2 Micromoles per liter
Standard Deviation 6.49
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 6, Week 24, n= 175
|
1.2 Micromoles per liter
Standard Deviation 5.79
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 6, Week 48, n= 134
|
1 Micromoles per liter
Standard Deviation 6.38
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 7, Week 24, n= 123
|
1.1 Micromoles per liter
Standard Deviation 5.75
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 7, Week 48, n= 97
|
0.7 Micromoles per liter
Standard Deviation 5.42
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 8, Week 24, n= 60
|
0.8 Micromoles per liter
Standard Deviation 5.09
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 8, Week 48, n= 28
|
0.4 Micromoles per liter
Standard Deviation 5.28
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 9, Week 24, n= 2
|
-0.5 Micromoles per liter
Standard Deviation 0.71
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Exit, n= 235
|
1.1 Micromoles per liter
Standard Deviation 5.57
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 1, Week 48, n= 250
|
-4.108 Micromoles per liter
Standard Deviation 58.0533
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 2, Week 24, n= 248
|
-6.4785 Micromoles per liter
Standard Deviation 57.0915
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 5, Week 24, n= 184
|
-5.296 Micromoles per liter
Standard Deviation 65.2308
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 2, Week 24, n= 248
|
-0.2 Micromoles per liter
Standard Deviation 5.76
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, 8 Week, Follow-Up, n= 107
|
1.3 Micromoles per liter
Standard Deviation 5.99
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 1, Week 4, n= 251
|
-1.653 Micromoles per liter
Standard Deviation 46.0197
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 1, Week 12, n= 248
|
-5.5803 Micromoles per liter
Standard Deviation 52.2256
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 1, Week 24, n= 246
|
-11.6488 Micromoles per liter
Standard Deviation 55.2277
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 1, Week 36, n= 238
|
-9.984 Micromoles per liter
Standard Deviation 57.2999
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 2, Week 48, n= 233
|
-4.6501 Micromoles per liter
Standard Deviation 60.3008
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 3, Week 24, n= 218
|
1.6919 Micromoles per liter
Standard Deviation 63.7367
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 3, Week 48, n= 209
|
-4.5543 Micromoles per liter
Standard Deviation 66.183
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 4, Week 24, n= 207
|
-4.8112 Micromoles per liter
Standard Deviation 60.2771
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 4, Week 48, n= 194
|
-2.0736 Micromoles per liter
Standard Deviation 60.7226
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 5, Week 48, n= 178
|
-5.7908 Micromoles per liter
Standard Deviation 65.6118
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 6, Week 24, n= 175
|
-2.084 Micromoles per liter
Standard Deviation 73.3489
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 6, Week 48, n= 134
|
-8.7672 Micromoles per liter
Standard Deviation 74.9078
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 7, Week 24, n= 123
|
-2.0775 Micromoles per liter
Standard Deviation 72.282
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 7, Week 48, n= 97
|
-0.1021 Micromoles per liter
Standard Deviation 60.8139
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 8, Week 24, n= 60
|
2.0387 Micromoles per liter
Standard Deviation 66.4246
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 8, Week 48, n= 28
|
1.1266 Micromoles per liter
Standard Deviation 62.7192
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 9, Week 24, n= 2
|
-1.782 Micromoles per liter
Standard Deviation 16.402
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Exit, n= 235
|
-7.3728 Micromoles per liter
Standard Deviation 71.4811
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, 8 Week, Follow-Up, n= 107
|
-6.6934 Micromoles per liter
Standard Deviation 84.8414
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 1, Week 4, n= 251
|
0.008 Micromoles per liter
Standard Deviation 2.0889
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 1, Week 12, n= 248
|
0.165 Micromoles per liter
Standard Deviation 2.4872
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 1, Week 24, n= 246
|
0.075 Micromoles per liter
Standard Deviation 2.2546
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 1, Week 36, n= 238
|
0.124 Micromoles per liter
Standard Deviation 2.4316
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 1, Week 48, n= 250
|
0.231 Micromoles per liter
Standard Deviation 2.3675
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 2, Week 24, n= 248
|
0.359 Micromoles per liter
Standard Deviation 2.7306
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 2, Week 48, n= 233
|
0.307 Micromoles per liter
Standard Deviation 3.0385
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 3, Week 24, n= 218
|
0.249 Micromoles per liter
Standard Deviation 2.8298
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 3, Week 48, n= 209
|
-0.115 Micromoles per liter
Standard Deviation 2.548
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 4, Week 24, n= 207
|
-0.276 Micromoles per liter
Standard Deviation 2.6718
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 4, Week 48, n= 194
|
-0.156 Micromoles per liter
Standard Deviation 2.823
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 5, Week 24, n= 184
|
-0.147 Micromoles per liter
Standard Deviation 2.8668
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 5, Week 48, n= 178
|
0.13 Micromoles per liter
Standard Deviation 2.7449
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 6, Week 24, n= 175
|
-0.067 Micromoles per liter
Standard Deviation 2.7954
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 6, Week 48, n= 134
|
0.268 Micromoles per liter
Standard Deviation 2.6834
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 7, Week 24, n= 123
|
-0.071 Micromoles per liter
Standard Deviation 2.7018
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 7, Week 48, n= 97
|
0.285 Micromoles per liter
Standard Deviation 2.85
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 8, Week 24, n= 60
|
0.529 Micromoles per liter
Standard Deviation 2.8249
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 8, Week 48, n= 28
|
0.175 Micromoles per liter
Standard Deviation 2.4435
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 9, Week 24, n= 2
|
-0.45 Micromoles per liter
Standard Deviation 1.4142
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Exit, n= 235
|
0.403 Micromoles per liter
Standard Deviation 2.8268
|
—
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, 8 Week, Follow-Up, n= 107
|
-0.191 Micromoles per liter
Standard Deviation 3.2759
|
—
|
PRIMARY outcome
Timeframe: Up to Week 440Population: MITT Population
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in creatinine clearance is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 1, Week 4, n= 251
|
-0.022 Milliliters per second
Standard Deviation 0.2312
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 1, Week 12, n= 248
|
0.01 Milliliters per second
Standard Deviation 0.2455
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 1, Week 24, n= 246
|
0.028 Milliliters per second
Standard Deviation 0.2831
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 1, Week 36, n= 238
|
0.034 Milliliters per second
Standard Deviation 0.3083
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 1, Week 48, n= 250
|
0.017 Milliliters per second
Standard Deviation 0.306
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 2, Week 24, n= 248
|
0.047 Milliliters per second
Standard Deviation 0.3145
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 2, Week 48, n= 233
|
0.04 Milliliters per second
Standard Deviation 0.3498
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 3, Week 24, n= 218
|
0.093 Milliliters per second
Standard Deviation 0.38
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 3, Week 48, n= 209
|
0.093 Milliliters per second
Standard Deviation 0.3784
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 4, Week 24, n= 207
|
0.13 Milliliters per second
Standard Deviation 0.3981
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 4, Week 48, n= 194
|
0.084 Milliliters per second
Standard Deviation 0.3628
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 5, Week 24, n= 184
|
0.087 Milliliters per second
Standard Deviation 0.3724
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 5, Week 48, n= 178
|
0.04 Milliliters per second
Standard Deviation 0.3652
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 6, Week 24, n= 175
|
0.035 Milliliters per second
Standard Deviation 0.3971
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 6, Week 48, n= 134
|
0.039 Milliliters per second
Standard Deviation 0.3985
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 7, Week 24, n= 123
|
-0.007 Milliliters per second
Standard Deviation 0.4482
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 7, Week 48, n= 97
|
0.005 Milliliters per second
Standard Deviation 0.4424
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 8, Week 24, n= 60
|
-0.018 Milliliters per second
Standard Deviation 0.4682
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 8, Week 48, n= 28
|
-0.042 Milliliters per second
Standard Deviation 0.2808
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Year 9, Week 24, n= 2
|
-0.083 Milliliters per second
Standard Deviation 0.165
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, Exit, n= 235
|
0.011 Milliliters per second
Standard Deviation 0.3986
|
—
|
|
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Creatinine clearance, 8 Week, Follow-Up, n= 106
|
0.036 Milliliters per second
Standard Deviation 0.3467
|
—
|
PRIMARY outcome
Timeframe: Up to Week 440Population: MITT Population
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 8, Week 48, n= 28
|
0.4 Ratio
Standard Deviation 5.28
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 9, Week 24, n= 2
|
-0.5 Ratio
Standard Deviation 0.71
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 1, Week 4, n= 251
|
-0.2 Ratio
Standard Deviation 4.69
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 1, Week 12, n= 248
|
-0.5 Ratio
Standard Deviation 4.86
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 1, Week 24, n= 246
|
-0.6 Ratio
Standard Deviation 5.31
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 1, Week 36, n= 238
|
-0.4 Ratio
Standard Deviation 5.07
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 1, Week 48, n= 250
|
-0.2 Ratio
Standard Deviation 5.29
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 2, Week 24, n= 248
|
-0.2 Ratio
Standard Deviation 5.76
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 2, Week 48, n= 233
|
0.3 Ratio
Standard Deviation 4.78
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 3, Week 24, n= 218
|
0.8 Ratio
Standard Deviation 5.63
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 3, Week 48, n= 209
|
0.9 Ratio
Standard Deviation 5.61
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 4, Week 24, n= 207
|
1.2 Ratio
Standard Deviation 5.86
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 4, Week 48, n= 194
|
0.9 Ratio
Standard Deviation 6.05
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 5, Week 24, n= 184
|
1 Ratio
Standard Deviation 5.52
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 5, Week 48, n= 178
|
1.2 Ratio
Standard Deviation 6.49
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 6, Week 24, n= 175
|
1.2 Ratio
Standard Deviation 5.79
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 6, Week 48, n= 134
|
1 Ratio
Standard Deviation 6.38
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 7, Week 24, n= 123
|
1.1 Ratio
Standard Deviation 5.75
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 7, Week 48, n= 97
|
0.7 Ratio
Standard Deviation 5.42
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Year 8, Week 24, n= 60
|
0.8 Ratio
Standard Deviation 5.09
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, Exit, n= 235
|
1.1 Ratio
Standard Deviation 5.57
|
—
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/creatinine, 8 Week, Follow-Up, n= 107
|
1.3 Ratio
Standard Deviation 5.99
|
—
|
PRIMARY outcome
Timeframe: Up to Week 432Population: MITT Population
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase and lactate dehydrogenase is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 9, Week 24, n= 2
|
-9.5 Units per liter
Standard Deviation 0.71
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Exit, n= 235
|
-6.5 Units per liter
Standard Deviation 56.73
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , 8 Week, Follow-Up, n= 107
|
-3.4 Units per liter
Standard Deviation 52.66
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 1, Week 48, n=250
|
2.2 Units per liter
Standard Deviation 39.98
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 2,Week 24, n= 248
|
1.2 Units per liter
Standard Deviation 27.97
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 2, Week 48,n= 233
|
1.9 Units per liter
Standard Deviation 28.88
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 3, Week 24, n=218
|
1.8 Units per liter
Standard Deviation 20.1
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 3, Week 48, n=209
|
-2.4 Units per liter
Standard Deviation 31.27
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 4, Week 24, n=207
|
2.5 Units per liter
Standard Deviation 45.58
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 4, Week 48, n=194
|
1.5 Units per liter
Standard Deviation 47.03
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 5,Week 24, n= 184
|
-0.4 Units per liter
Standard Deviation 32.51
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 5, Week 48, n=178
|
0.6 Units per liter
Standard Deviation 40.11
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 6, Week 24, n=175
|
-3.3 Units per liter
Standard Deviation 40.3
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 6, Week 48, n=134
|
-4.4 Units per liter
Standard Deviation 37.08
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 7, Week 24, n=123
|
-7.2 Units per liter
Standard Deviation 38.88
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 7, Week 48, n= 97
|
-8.8 Units per liter
Standard Deviation 36.19
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 8, Week 24, n= 60
|
-12.9 Units per liter
Standard Deviation 35.44
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 8, Week 48, n= 28
|
-6.9 Units per liter
Standard Deviation 31.02
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 9, Week 24, n= 2
|
2.5 Units per liter
Standard Deviation 3.54
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Exit, n= 235
|
-2.2 Units per liter
Standard Deviation 35.29
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, 8 Week,Follow-Up,n=107
|
2.1 Units per liter
Standard Deviation 35.9
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 1, Week 4, n= 242
|
0.2 Units per liter
Standard Deviation 26.46
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 1, Week 12, n= 245
|
-2.4 Units per liter
Standard Deviation 29.56
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 1, Week 24, n= 244
|
-2.2 Units per liter
Standard Deviation 37.57
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 1, Week 36, n= 234
|
-2.8 Units per liter
Standard Deviation 34.88
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 1, Week 48, n= 250
|
-4.3 Units per liter
Standard Deviation 35.5
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 2, Week 24, n= 246
|
-4.8 Units per liter
Standard Deviation 36.29
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 2, Week 48, n= 231
|
-5.4 Units per liter
Standard Deviation 40.42
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 3, Week 24, n= 215
|
-8.1 Units per liter
Standard Deviation 40.13
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 3, Week 48, n= 205
|
-9.2 Units per liter
Standard Deviation 47.95
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 4, Week 24, n= 204
|
-7.7 Units per liter
Standard Deviation 45.12
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 4, Week 48, n= 191
|
-4.7 Units per liter
Standard Deviation 53.17
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 5, Week 24, n= 184
|
-5.5 Units per liter
Standard Deviation 48.34
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 5, Week 48, n= 176
|
-10.3 Units per liter
Standard Deviation 49.81
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 6, Week 24, n= 172
|
-2.7 Units per liter
Standard Deviation 72.28
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 6, Week 48, n= 134
|
-5.3 Units per liter
Standard Deviation 55.64
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 7, Week 24, n= 121
|
-7.9 Units per liter
Standard Deviation 53.17
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 7, Week 48, n= 97
|
-9.5 Units per liter
Standard Deviation 57.15
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 8, Week 24, n= 60
|
-11.2 Units per liter
Standard Deviation 58.81
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Lactate dehydrogenase , Year 8, Week 48, n= 28
|
-5.5 Units per liter
Standard Deviation 81.78
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 1, Week 4, n= 251
|
0.5 Units per liter
Standard Deviation 14.89
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 1, Week 12, n= 248
|
-0.5 Units per liter
Standard Deviation 11.01
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 1, Week 24, n= 246
|
-0.1 Units per liter
Standard Deviation 12.27
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 1, Week 36, n= 238
|
0.3 Units per liter
Standard Deviation 14.12
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 1, Week 48, n= 250
|
0.4 Units per liter
Standard Deviation 14.64
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 2, Week 24, n= 248
|
0.8 Units per liter
Standard Deviation 12.33
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 2, Week 48, n= 233
|
1.7 Units per liter
Standard Deviation 16.67
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 3, Week 24, n= 218
|
0.9 Units per liter
Standard Deviation 12.32
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 3, Week 48, n= 209
|
0.4 Units per liter
Standard Deviation 14.93
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 4, Week 24, n= 207
|
1.7 Units per liter
Standard Deviation 17.02
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 4, Week 48, n= 194
|
2.4 Units per liter
Standard Deviation 24.4
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 5, Week 24, n= 184
|
1.8 Units per liter
Standard Deviation 15.79
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 5, Week 48, n= 178
|
0.3 Units per liter
Standard Deviation 17.15
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 6, Week 24, n= 175
|
1 Units per liter
Standard Deviation 20.87
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 6, Week 48, n= 134
|
-0.1 Units per liter
Standard Deviation 13.25
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 7, Week 24, n= 123
|
-2.8 Units per liter
Standard Deviation 13.96
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 7, Week 48, n= 97
|
-2.8 Units per liter
Standard Deviation 15.06
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 8, Week 24, n= 60
|
-5.1 Units per liter
Standard Deviation 12.06
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 8, Week 48, n= 28
|
-0.6 Units per liter
Standard Deviation 11.39
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Year 9, Week 24, n= 2
|
5 Units per liter
Standard Deviation 4.24
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, Exit, n= 235
|
-1.2 Units per liter
Standard Deviation 13.77
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alanine aminotransferase, 8 Week, Follow-Up, n= 10
|
0.1 Units per liter
Standard Deviation 14.46
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 1, Week 4, n= 251
|
-0.8 Units per liter
Standard Deviation 13.82
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 1, Week 12, n= 248
|
0.4 Units per liter
Standard Deviation 17.41
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 1, Week 24, n= 246
|
0.3 Units per liter
Standard Deviation 16.72
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 1, Week 36, n= 238
|
1.2 Units per liter
Standard Deviation 16.2
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 1, Week 48, n= 250
|
3.3 Units per liter
Standard Deviation 19.97
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 2, Week 24, n= 248
|
4.9 Units per liter
Standard Deviation 21.17
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 2, Week 48, n= 233
|
5.8 Units per liter
Standard Deviation 21.25
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 3, Week 24, n= 218
|
5.4 Units per liter
Standard Deviation 20.61
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 3, Week 48, n= 209
|
3.1 Units per liter
Standard Deviation 21.89
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 4, Week 24, n= 207
|
6.5 Units per liter
Standard Deviation 29.67
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 4, Week 48, n= 194
|
6.2 Units per liter
Standard Deviation 33.31
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 5, Week 24, n= 184
|
7.8 Units per liter
Standard Deviation 24.75
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 5, Week 48, n= 178
|
6.7 Units per liter
Standard Deviation 26.55
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 6, Week 24, n= 175
|
7.5 Units per liter
Standard Deviation 33.87
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 6, Week 48, n= 134
|
6.6 Units per liter
Standard Deviation 26.36
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 7, Week 24, n= 123
|
5.5 Units per liter
Standard Deviation 25
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 7, Week 48, n= 97
|
5.2 Units per liter
Standard Deviation 24.83
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 8, Week 24, n= 60
|
2.3 Units per liter
Standard Deviation 29.63
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 8, Week 48, n= 28
|
0.3 Units per liter
Standard Deviation 38.97
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Year 9, Week 24, n= 2
|
19.5 Units per liter
Standard Deviation 24.75
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, Exit, n= 235
|
4.6 Units per liter
Standard Deviation 23.59
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Alkaline phosphatase, 8 Week, Follow-Up, n= 107
|
2.8 Units per liter
Standard Deviation 26.98
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase ,Year 1, Week 4, n= 242
|
0.3 Units per liter
Standard Deviation 11.18
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase ,Year 1,Week 12, n= 245
|
-0.6 Units per liter
Standard Deviation 9.37
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase ,Year 1,Week 24, n= 244
|
-0.8 Units per liter
Standard Deviation 8.14
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase,Year 1,Week 36,n=234
|
-0.3 Units per liter
Standard Deviation 11.29
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase ,Year 1,Week 48, n= 250
|
-0.2 Units per liter
Standard Deviation 10.67
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase , Year 2, Week 24,n=246
|
0.4 Units per liter
Standard Deviation 10.97
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase , Year 2, Week 48,n=231
|
1 Units per liter
Standard Deviation 12.24
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase , Year 3,Week 24,n=215
|
0.2 Units per liter
Standard Deviation 9.49
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase ,Year 3,Week 48, n= 205
|
0.1 Units per liter
Standard Deviation 14.63
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase , Year 4,Week 24, n=204
|
1.3 Units per liter
Standard Deviation 14.74
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase , Year 4, Week 48,n=191
|
3.7 Units per liter
Standard Deviation 32.99
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase , Year 5,Week 24, n=184
|
1.7 Units per liter
Standard Deviation 16.27
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase , Year 5,Week 48, n=176
|
0.6 Units per liter
Standard Deviation 15.15
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase , Year 6,Week 24,n= 172
|
2.4 Units per liter
Standard Deviation 22.03
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase , Year 6,Week 48, n=134
|
1 Units per liter
Standard Deviation 13.55
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase , Year 7,Week 24,n=121
|
-0.6 Units per liter
Standard Deviation 13.14
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase , Year 7, Week 48, n=97
|
-1.1 Units per liter
Standard Deviation 14.1
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase , Year 8, Week 24,n=60
|
-2.7 Units per liter
Standard Deviation 9.66
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase , Year 8, Week 48, n=28
|
0.1 Units per liter
Standard Deviation 8.02
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase , Year 9, Week 24, n= 2
|
5 Units per liter
Standard Deviation 4.24
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase , Exit, n= 235
|
-0.4 Units per liter
Standard Deviation 15.07
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Aspartate aminotransferase,8 Week,Follow-Up, n=107
|
-0.7 Units per liter
Standard Deviation 12.45
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 1, Week 4, n= 251
|
0.5 Units per liter
Standard Deviation 22.54
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 1,Week 12, n= 248
|
0.5 Units per liter
Standard Deviation 21.44
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 1,Week 24, n= 246
|
-1.3 Units per liter
Standard Deviation 20.21
|
—
|
|
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Gamma glutamyl transferase, Year 1, Week 36, n=238
|
-0.1 Units per liter
Standard Deviation 18.64
|
—
|
PRIMARY outcome
Timeframe: Up to Week 440Population: MITT Population
Immunogenic response was assessed by binding confirmatory assay at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Number of participants with the indicated immunogenic response are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Results of binding confirmatory assay were categorized as negative, persistent positive (defined as a positive immunogenic response that occurs at least 2 consecutive assessments or a single result at the final assessment) or transient positive (defined as a single positive immunogenic response that does not occur at the final assessment). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Number of Participants With the Indicated Immunogenic Response
Negative, Year 0-1, n=267
|
262 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Persistent positive, Year 2-3, n=240
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Negative, Year 1-2, n=255
|
251 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Negative, Year 2-3, n=240
|
239 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Negative, Year 3-4, n=214
|
213 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Negative, Year 4-5, n=195
|
195 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Negative, Year 5-6, n=185
|
185 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Negative, Year 6-7, n=125
|
125 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Negative, Year 7 plus, n=63
|
63 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Transient positive, Year 0-1, n=267
|
5 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Transient positive, Year 1-2, n=255
|
4 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Transient positive, Year 2-3, n=240
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Transient positive, Year 3-4, n=214
|
1 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Transient positive, Year 4-5, n=195
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Transient positive, Year 5-6, n=185
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Transient positive, Year 6-7, n=125
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Transient positive, Year 7 plus, n=63
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Persistent positive, Year 0-1, n=267
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Persistent positive, Year 1-2, n=255
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Persistent positive, Year 3-4, n=214
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Persistent positive, Year 4-5, n=195
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Persistent positive, Year 5-6, n=185
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Persistent positive, Year 6-7, n=125
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Persistent positive, Year 7 plus, n=63
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Unknown, Year 0-1, n=267
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Unknown, Year 1-2, n=255
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Unknown, Year 2-3, n=240
|
1 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Unknown, Year 3-4, n=214
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Unknown, Year 4-5, n=195
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Unknown, Year 5-6, n=185
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Unknown, Year 6-7, n=125
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Immunogenic Response
Unknown, Year 7 plus, n=63
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to Week 432Population: MITT Population
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Year 2 , Week 48, n= 236
|
73.5 Millimeters of mercury
Standard Deviation 10.17
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Year 3 , Week 24, n= 223
|
73.6 Millimeters of mercury
Standard Deviation 10.32
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Year 3 , Week 48, n= 214
|
73.4 Millimeters of mercury
Standard Deviation 10.12
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Year 4 , Week 24, n= 214
|
74.4 Millimeters of mercury
Standard Deviation 9.56
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Year 4 , Week 48, n= 199
|
75.2 Millimeters of mercury
Standard Deviation 10.52
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Year 5 , Week 24, n= 187
|
74.3 Millimeters of mercury
Standard Deviation 9.89
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Year 5 , Week 48, n= 185
|
73.4 Millimeters of mercury
Standard Deviation 10.15
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Year 6 , Week 24, n= 178
|
74.1 Millimeters of mercury
Standard Deviation 10.25
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Year 6 , Week 48, n= 138
|
73.9 Millimeters of mercury
Standard Deviation 10.78
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Year 7 , Week 24, n= 124
|
75.2 Millimeters of mercury
Standard Deviation 9.5
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Year 7 , Week 48, n= 98
|
73.1 Millimeters of mercury
Standard Deviation 9.94
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Baseline, n= 268
|
74.3 Millimeters of mercury
Standard Deviation 9.92
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Year 1 , Week 24, n= 255
|
74.5 Millimeters of mercury
Standard Deviation 9.96
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Year 1 , Week 48, n= 255
|
73.5 Millimeters of mercury
Standard Deviation 9.92
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Year 2 , Week 24, n= 251
|
74.5 Millimeters of mercury
Standard Deviation 11.01
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Year 8 , Week 24, n= 60
|
73.4 Millimeters of mercury
Standard Deviation 9.79
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Year 8 , Week 48, n= 29
|
73.6 Millimeters of mercury
Standard Deviation 8.27
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Year 9 , Week 24, n= 2
|
90 Millimeters of mercury
Standard Deviation 12.73
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
DBP, Exit, n= 233
|
75.2 Millimeters of mercury
Standard Deviation 9.77
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Baseline, n= 268
|
119.7 Millimeters of mercury
Standard Deviation 15.75
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Year 1 , Week 24, n= 255
|
120 Millimeters of mercury
Standard Deviation 16.14
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Year 1 , Week 48, n= 255
|
120.2 Millimeters of mercury
Standard Deviation 14.66
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Year 2 , Week 24, n= 251
|
120.1 Millimeters of mercury
Standard Deviation 16.49
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Year 2 , Week 48, n= 236
|
119.1 Millimeters of mercury
Standard Deviation 15.22
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Year 3 , Week 24, n= 223
|
120.7 Millimeters of mercury
Standard Deviation 16.23
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Year 3 , Week 48, n= 214
|
120.2 Millimeters of mercury
Standard Deviation 14.44
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Year 4 , Week 24, n= 214
|
121.4 Millimeters of mercury
Standard Deviation 14.61
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Year 4 , Week 48, n= 199
|
121.4 Millimeters of mercury
Standard Deviation 15.03
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Year 5 , Week 24, n= 187
|
120.7 Millimeters of mercury
Standard Deviation 14.92
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Year 5 , Week 48, n= 185
|
119.9 Millimeters of mercury
Standard Deviation 15.29
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Year 6 , Week 24, n= 178
|
121.5 Millimeters of mercury
Standard Deviation 15.29
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Year 6 , Week 48, n= 138
|
121.7 Millimeters of mercury
Standard Deviation 15.86
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Year 7 , Week 24, n= 124
|
121.6 Millimeters of mercury
Standard Deviation 14.73
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Year 7 , Week 48, n= 98
|
120.6 Millimeters of mercury
Standard Deviation 14.19
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Year 8 , Week 24, n= 60
|
120.5 Millimeters of mercury
Standard Deviation 14.65
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Year 8 , Week 48, n= 29
|
118.2 Millimeters of mercury
Standard Deviation 11.73
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Year 9 , Week 24, n= 2
|
115.5 Millimeters of mercury
Standard Deviation 6.36
|
—
|
|
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
SBP, Exit, n= 233
|
123.3 Millimeters of mercury
Standard Deviation 15.53
|
—
|
PRIMARY outcome
Timeframe: Up to Week 440Population: MITT Population
Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% increase from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=91 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
n=177 Participants
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.
Year 0-1, n= 91, 177
|
7.7 Percentage of Participants
|
23.2 Percentage of Participants
|
|
Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.
Year 1-2, n= 79, 177
|
3.8 Percentage of Participants
|
20.3 Percentage of Participants
|
|
Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.
Year 2-3, n= 75, 168
|
2.7 Percentage of Participants
|
8.3 Percentage of Participants
|
|
Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.
Year 3-4, n= 68, 150
|
4.4 Percentage of Participants
|
6 Percentage of Participants
|
|
Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.
Year 4-5, n= 61, 139
|
4.9 Percentage of Participants
|
9.4 Percentage of Participants
|
|
Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.
Year 5-6, n= 59, 132
|
5.1 Percentage of Participants
|
9.1 Percentage of Participants
|
|
Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.
Year 6-7, n= 12, 118
|
8.3 Percentage of Participants
|
11.9 Percentage of Participants
|
|
Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.
Year 7+, n= 0, 65
|
0 Percentage of Participants
|
10.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Week 440Population: MITT Population. Only those subjects with abnormal (\>124 umol/L) creatinine at baseline by year interval.
Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% reduction from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=91 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
n=177 Participants
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.
Year 0-1, n= 6, 3
|
16.7 Percentage of Participants
|
33.3 Percentage of Participants
|
|
Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.
Year 1-2, n= 5, 3
|
20 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.
Year 2-3, n= 3, 3
|
33.3 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.
Year 3-4, n= 2, 2
|
0 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.
Year 4-5, n= 2, 2
|
0 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.
Year 5-6, n= 2, 2
|
50 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.
Year 6-7, n= 1, 1
|
0 Percentage of Participants
|
100 Percentage of Participants
|
|
Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.
Year 7+, n= 0, 0
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to Week 392Population: MITT Population
Serum immunoglobulin G (IgG) was collected at Baseline (BL) (Day 0), at Week 24 and Week 48 in first year, at Week 48 in subsequent years up to 8 years and at follow-up (up to 8 weeks post last infusion). Number of participants with serum immunoglobulins below the lower limit of normal (LLN) (\<0.5 nanograms per milliliter \[ng/mL\]) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.
Baseline, n=268
|
8 Participants
|
—
|
|
Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.
Year 1, Week 24, n= 252
|
14 Participants
|
—
|
|
Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.
Year 1, Week 48, n= 255
|
16 Participants
|
—
|
|
Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.
Year 2, Week 48, n= 237
|
19 Participants
|
—
|
|
Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.
Year 3, Week 48, n= 224
|
17 Participants
|
—
|
|
Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.
Year 4, Week 48, n= 208
|
26 Participants
|
—
|
|
Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.
Year 5, Week 48, n= 190
|
19 Participants
|
—
|
|
Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.
Year 6, Week 48, n= 150
|
21 Participants
|
—
|
|
Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.
Year 7, Week 48, n= 112
|
21 Participants
|
—
|
|
Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.
Year 8, Week 48, n= 59
|
5 Participants
|
—
|
|
Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.
Exit, n= 235
|
29 Participants
|
—
|
|
Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.
8 Week Follow-Up, n= 106
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 440Population: MIIT Population
The percentage of participants achieving a SLE Responder Index (SRI) response at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Response is defined as:\>=4 point reduction from the BL in the safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of \<0.30 points from the BL) in Physicians Global Assessment (PGA), and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with the BL. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Percentage of Participants Achieving SRI Response at Indicated Time Points
Year 1 , Week 24, n= 229
|
41.9 Percentage of Participants
|
—
|
|
Percentage of Participants Achieving SRI Response at Indicated Time Points
Year 1 , Week 48, n= 225
|
45.3 Percentage of Participants
|
—
|
|
Percentage of Participants Achieving SRI Response at Indicated Time Points
Year 2 , Week 24, n= 227
|
49.3 Percentage of Participants
|
—
|
|
Percentage of Participants Achieving SRI Response at Indicated Time Points
Year 2 , Week 48, n= 204
|
49 Percentage of Participants
|
—
|
|
Percentage of Participants Achieving SRI Response at Indicated Time Points
Year 3 , Week 24, n= 211
|
51.2 Percentage of Participants
|
—
|
|
Percentage of Participants Achieving SRI Response at Indicated Time Points
Year 3 , Week 48, n= 185
|
58.4 Percentage of Participants
|
—
|
|
Percentage of Participants Achieving SRI Response at Indicated Time Points
Year 4 , Week 24, n= 188
|
56.9 Percentage of Participants
|
—
|
|
Percentage of Participants Achieving SRI Response at Indicated Time Points
Year 4 , Week 48, n= 174
|
64.9 Percentage of Participants
|
—
|
|
Percentage of Participants Achieving SRI Response at Indicated Time Points
Year 5 , Week 24, n= 168
|
66.7 Percentage of Participants
|
—
|
|
Percentage of Participants Achieving SRI Response at Indicated Time Points
Year 5 , Week 48, n= 157
|
62.4 Percentage of Participants
|
—
|
|
Percentage of Participants Achieving SRI Response at Indicated Time Points
Year 6 , Week 24, n= 164
|
69.5 Percentage of Participants
|
—
|
|
Percentage of Participants Achieving SRI Response at Indicated Time Points
Year 6 , Week 48, n= 123
|
74 Percentage of Participants
|
—
|
|
Percentage of Participants Achieving SRI Response at Indicated Time Points
Year 7 , Week 24, n= 119
|
75.6 Percentage of Participants
|
—
|
|
Percentage of Participants Achieving SRI Response at Indicated Time Points
Year 7 , Week 48, n= 93
|
78.5 Percentage of Participants
|
—
|
|
Percentage of Participants Achieving SRI Response at Indicated Time Points
Year 8 , Week 24, n= 63
|
66.7 Percentage of Participants
|
—
|
|
Percentage of Participants Achieving SRI Response at Indicated Time Points
Year 8 , Week 48, n= 29
|
65.5 Percentage of Participants
|
—
|
|
Percentage of Participants Achieving SRI Response at Indicated Time Points
Year 9 , Week 24, n= 2
|
0 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 432Population: MITT Population
Anti-double stranded deoxyribonucleic acid (anti-dsDNA) levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks in participants who were positive at baseline (anti-dsDNA \>=30 International Units/milliliter \[IU/mL\]). Observed anti-dsDNA levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=135 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Baseline, n= 135
|
193 International units per milliliter
Interval 34.0 to 201.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Year 1, Week 24, n= 128
|
127.5 International units per milliliter
Interval 29.0 to 201.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Year 1, Week 48, n= 130
|
123 International units per milliliter
Interval 29.0 to 201.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Year 2, Week 24, n= 126
|
93.5 International units per milliliter
Interval 29.0 to 349.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Year 2, Week 48, n= 128
|
95 International units per milliliter
Interval 5.0 to 2505.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Year 3, Week 24, n= 120
|
82.5 International units per milliliter
Interval 5.0 to 1545.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Year 3, Week 48, n= 116
|
86.5 International units per milliliter
Interval 5.0 to 556.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Year 4, Week 24, n= 112
|
87.5 International units per milliliter
Interval 5.0 to 2305.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Year 4, Week 48, n= 100
|
76.5 International units per milliliter
Interval 5.0 to 1873.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Year 5, Week 24, n= 98
|
60 International units per milliliter
Interval 5.0 to 1188.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Year 5, Week 48, n= 96
|
47.5 International units per milliliter
Interval 5.0 to 1765.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Year 6, Week 24, n= 87
|
47 International units per milliliter
Interval 5.0 to 1863.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Year 6, Week 48, n= 66
|
50 International units per milliliter
Interval 5.0 to 1018.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Year 7, Week 24, n= 63
|
35 International units per milliliter
Interval 5.0 to 2648.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Year 7, Week 48, n= 48
|
32 International units per milliliter
Interval 5.0 to 736.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Year 8, Week 24, n= 35
|
29 International units per milliliter
Interval 5.0 to 521.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Year 8, Week 48, n= 16
|
50.5 International units per milliliter
Interval 5.0 to 439.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Year 9, Week 24, n= 1
|
45 International units per milliliter
Interval 45.0 to 45.0
|
—
|
|
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Exit, n= 120
|
37 International units per milliliter
Interval 5.0 to 1608.0
|
—
|
SECONDARY outcome
Timeframe: Up to Week 432Population: MITT Population
Anti-dsDNA levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants who were positive at baseline (anti-dsDNA ≥30 IU/mL). Median percent change from Baseline in anti-dsDNA levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x (\[Post-Dose Visit Value - Baseline\] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=135 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Year 1, Week 48, n= 130
|
-15.58 Percentage change
Interval -84.2 to 183.1
|
—
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Year 1, Week 24, n= 128
|
-9.77 Percentage change
Interval -75.6 to 54.6
|
—
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Year 2, Week 24, n= 126
|
-27.5 Percentage change
Interval -84.7 to 181.7
|
—
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Year 2, Week 48, n= 128
|
-30.12 Percentage change
Interval -90.6 to 1253.6
|
—
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Year 3, Week 24, n= 120
|
-34.22 Percentage change
Interval -90.6 to 668.7
|
—
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Year 3, Week 48, n= 116
|
-34.92 Percentage change
Interval -90.6 to 176.6
|
—
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Year 4, Week 24, n= 112
|
-38.58 Percentage change
Interval -90.6 to 1046.8
|
—
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Year 4, Week 48, n= 100
|
-54.46 Percentage change
Interval -96.0 to 831.8
|
—
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Year 5, Week 24, n= 98
|
-54.39 Percentage change
Interval -96.5 to 491.0
|
—
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Year 5, Week 48, n= 96
|
-64.43 Percentage change
Interval -97.5 to 778.1
|
—
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Year 6, Week 24, n= 87
|
-64.04 Percentage change
Interval -97.5 to 826.9
|
—
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Year 6, Week 48, n= 66
|
-64.91 Percentage change
Interval -97.5 to 406.5
|
—
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Year 7, Week 24, n= 63
|
-74.74 Percentage change
Interval -97.5 to 1217.4
|
—
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Year 7, Week 48, n= 48
|
-78.15 Percentage change
Interval -97.5 to 557.1
|
—
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Year 8, Week 24, n= 35
|
-79.1 Percentage change
Interval -97.5 to 365.2
|
—
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Year 8, Week 48, n= 16
|
-72.38 Percentage change
Interval -97.5 to 292.0
|
—
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Year 9, Week 24, n= 1
|
-77.6 Percentage change
Interval -77.6 to -77.6
|
—
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Exit, n= 120
|
-66.67 Percentage change
Interval -97.5 to 700.0
|
—
|
SECONDARY outcome
Timeframe: Up to Week 440Population: MITT Population
Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at exit visit in participants with low complements at Baseline (C3 \<90 milligram per deciliter (mg/dL) and C4 \<16 mg/dL). Observed complement C3 and C4 levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=135 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Baseline, n= 86
|
76 Milligrams per deciliter
Interval 40.0 to 89.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Year 1, Week 24, n= 83
|
80 Milligrams per deciliter
Interval 43.0 to 160.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Year 1, Week 48, n= 83
|
86 Milligrams per deciliter
Interval 38.0 to 144.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Year 2, Week 24, n= 81
|
85 Milligrams per deciliter
Interval 46.0 to 157.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Year 2, Week 48, n= 80
|
88.5 Milligrams per deciliter
Interval 36.0 to 137.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Year 3, Week 24, n= 74
|
90.5 Milligrams per deciliter
Interval 55.0 to 133.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Year 3, Week 48, n= 73
|
93 Milligrams per deciliter
Interval 51.0 to 139.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Year 4, Week 24, n= 72
|
94 Milligrams per deciliter
Interval 47.0 to 150.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Year 4, Week 48, n= 66
|
95 Milligrams per deciliter
Interval 58.0 to 137.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Year 5, Week 24, n= 63
|
99 Milligrams per deciliter
Interval 64.0 to 193.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Year 5, Week 48, n= 61
|
97 Milligrams per deciliter
Interval 56.0 to 172.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Year 6, Week 24, n= 55
|
99 Milligrams per deciliter
Interval 54.0 to 161.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Year 6, Week 48, n= 37
|
103 Milligrams per deciliter
Interval 47.0 to 158.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Year 7, Week 24, n= 41
|
103 Milligrams per deciliter
Interval 50.0 to 147.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Year 7, Week 48, n= 32
|
110 Milligrams per deciliter
Interval 51.0 to 173.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Year 8, Week 24, n= 20
|
110.5 Milligrams per deciliter
Interval 76.0 to 177.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Year 8, Week 48, n= 9
|
104 Milligrams per deciliter
Interval 79.0 to 158.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C3, Exit, n= 74
|
103 Milligrams per deciliter
Interval 56.0 to 173.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Baseline, n=98
|
10 Milligrams per deciliter
Interval 3.0 to 15.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Year 1, Week 24, n=95
|
13 Milligrams per deciliter
Interval 3.0 to 25.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Year 1, Week 48, n=93
|
15 Milligrams per deciliter
Interval 4.0 to 28.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Year 2, Week 24, n=93
|
15 Milligrams per deciliter
Interval 3.0 to 29.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Year 2, Week 48, n=94
|
16 Milligrams per deciliter
Interval 4.0 to 37.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Year 3, Week 24, n=84
|
15.5 Milligrams per deciliter
Interval 4.0 to 31.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Year 3, Week 48, n=83
|
16 Milligrams per deciliter
Interval 3.0 to 35.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Year 4, Week 24, n=81
|
16 Milligrams per deciliter
Interval 3.0 to 38.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Year 4, Week 48, n=71
|
17 Milligrams per deciliter
Interval 4.0 to 26.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Year 5, Week 24, n=70
|
18 Milligrams per deciliter
Interval 4.0 to 40.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Year 5, Week 48, n=70
|
18 Milligrams per deciliter
Interval 3.0 to 39.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Year 6, Week 24, n=62
|
18 Milligrams per deciliter
Interval 5.0 to 36.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Year 6, Week 48, n=45
|
18 Milligrams per deciliter
Interval 5.0 to 29.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Year 7, Week 24, n=49
|
19 Milligrams per deciliter
Interval 6.0 to 34.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Year 7, Week 48, n=35
|
19 Milligrams per deciliter
Interval 6.0 to 34.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Year 8, Week 24, n=24
|
20.5 Milligrams per deciliter
Interval 10.0 to 35.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Year 8, Week 48, n=12
|
18 Milligrams per deciliter
Interval 7.0 to 36.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Year 9, Week 24, n=1
|
22 Milligrams per deciliter
Interval 22.0 to 22.0
|
—
|
|
Observed Complement C3 and C4 Levels at Indicated Time Points
C4, Exit, n=85
|
18 Milligrams per deciliter
Interval 4.0 to 41.0
|
—
|
SECONDARY outcome
Timeframe: Up to Week 432Population: MITT Population
Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants with low complements at Baseline (C3 \<90 milligrams per decilitre (mg/dL) and C4 \<16 mg/dL). Median percent change from Baseline in complement C3 and C4 levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x (\[Post-Dose Visit Value - Baseline\] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=135 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Year 2, Week 24, n=93
|
42.86 Percent Change
Interval -57.1 to 350.0
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C3, Year 1, Week 24, n= 83
|
10.91 Percent Change
Interval -33.0 to 281.0
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C3, Year 1, Week 48, n= 83
|
17.86 Percent Change
Interval -45.3 to 104.8
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C3, Year 2, Week 24, n= 81
|
18.64 Percent Change
Interval -23.3 to 192.9
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C3, Year 2, Week 48, n= 80
|
16.71 Percent Change
Interval -37.9 to 163.3
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C3, Year 3, Week 24, n= 74
|
24.26 Percent Change
Interval -17.3 to 161.2
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C3, Year 3, Week 48, n= 73
|
22.73 Percent Change
Interval -34.6 to 163.3
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C3, Year 4, Week 24, n= 72
|
32.43 Percent Change
Interval -32.9 to 206.1
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C3, Year 4, Week 48, n= 66
|
30.63 Percent Change
Interval -27.5 to 177.6
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C3, Year 5, Week 24, n= 63
|
33.93 Percent Change
Interval -24.7 to 175.7
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C3, Year 5, Week 48, n= 61
|
34.29 Percent Change
Interval -17.9 to 173.5
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C3, Year 6, Week 24, n= 55
|
35.71 Percent Change
Interval -18.0 to 159.7
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C3, Year 6, Week 48, n= 37
|
34.57 Percent Change
Interval -32.9 to 166.7
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C3, Year 7, Week 24, n= 41
|
36.11 Percent Change
Interval -34.2 to 137.1
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C3, Year 7, Week 48, n= 32
|
42.04 Percent Change
Interval -36.3 to 179.0
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C3, Year 8, Week 24, n= 20
|
36.97 Percent Change
Interval 7.7 to 185.5
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C3, Year 8, Week 48, n= 9
|
30.16 Percent Change
Interval 5.0 to 163.3
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C3, Exit, n= 74
|
39.05 Percent Change
Interval -25.6 to 195.2
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Year 1, Week 24, n=95
|
30.77 Percent Change
Interval -53.3 to 275.0
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Year 1, Week 48, n=93
|
40 Percent Change
Interval -40.0 to 200.0
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Year 2, Week 48, n=94
|
47.73 Percent Change
Interval -33.3 to 270.0
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Year 3, Week 24, n=84
|
50 Percent Change
Interval -20.0 to 266.7
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Year 3, Week 48, n=83
|
46.15 Percent Change
Interval -40.0 to 250.0
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Year 4, Week 24, n=81
|
57.14 Percent Change
Interval -70.0 to 450.0
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Year 4, Week 48, n=71
|
58.33 Percent Change
Interval -42.9 to 433.3
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Year 5, Week 24, n=70
|
70.33 Percent Change
Interval -30.0 to 500.0
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Year 5, Week 48, n=70
|
65.15 Percent Change
Interval -40.0 to 566.7
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Year 6, Week 24, n=62
|
71.36 Percent Change
Interval -10.0 to 800.0
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Year 6, Week 48, n=45
|
57.14 Percent Change
Interval -40.0 to 600.0
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Year 7, Week 24, n=49
|
63.64 Percent Change
Interval -40.0 to 700.0
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Year 7, Week 48, n=35
|
62.5 Percent Change
Interval -14.3 to 900.0
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Year 8, Week 24, n=24
|
78.97 Percent Change
Interval 0.0 to 900.0
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Year 8, Week 48, n=12
|
69.74 Percent Change
Interval -30.0 to 1100.0
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Year 9, Week 24, n=1
|
100 Percent Change
Interval 100.0 to 100.0
|
—
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
C4, Exit, n=85
|
75 Percent Change
Interval -53.8 to 1066.7
|
—
|
SECONDARY outcome
Timeframe: Up to Week 432Population: MITT Population
Trends for reduction in prednisone use in participants receiving belimumab were observed up to 432 weeks. Percentage of participants with daily prednisone dose reduced to \<=7.5 mg/day from \>7.5 mg/kg at the Baseline are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=86 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Year 1, Week 24, n= 80
|
2.5 Percentage of Participants
|
—
|
|
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Year 1, Week 48, n= 81
|
21 Percentage of Participants
|
—
|
|
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Year 2, Week 24, n= 78
|
38.5 Percentage of Participants
|
—
|
|
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Year 2, Week 48, n= 76
|
40.8 Percentage of Participants
|
—
|
|
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Year 3, Week 24, n= 64
|
50 Percentage of Participants
|
—
|
|
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Year 3, Week 48, n= 63
|
41.3 Percentage of Participants
|
—
|
|
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Year 4, Week 24, n= 65
|
43.1 Percentage of Participants
|
—
|
|
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Year 4, Week 48, n= 62
|
37.1 Percentage of Participants
|
—
|
|
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Year 5, Week 24, n= 57
|
33.3 Percentage of Participants
|
—
|
|
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Year 5, Week 48, n= 57
|
38.6 Percentage of Participants
|
—
|
|
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Year 6, Week 24, n= 55
|
34.5 Percentage of Participants
|
—
|
|
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Year 6, Week 48, n= 47
|
42.6 Percentage of Participants
|
—
|
|
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Year 7, Week 24, n= 42
|
38.1 Percentage of Participants
|
—
|
|
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Year 7, Week 48, n= 38
|
39.5 Percentage of Participants
|
—
|
|
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Year 8, Week 24, n= 24
|
50 Percentage of Participants
|
—
|
|
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Year 8, Week 48, n= 12
|
58.3 Percentage of Participants
|
—
|
|
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Year 9, Week 24, n= 2
|
100 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 432Population: MITT Population
Proteinuria is defined as the presence of an excess of serum proteins in the urine. Trends for reduction in proteinuria in participants receiving belimumab were assessed up to 432 weeks and at Exit visit. Percentage of participants with \>= 50% reduction in proteinuria among participants with Baseline proteinuria \>0.5 g/24 hour (hr) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=36 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Year 1, Week 24, n=34
|
41.2 Percentage of Participants
|
—
|
|
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Year 1, Week 48, n=33
|
63.6 Percentage of Participants
|
—
|
|
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Year 2, Week 24, n=33
|
60.6 Percentage of Participants
|
—
|
|
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Year 2, Week 48, n=30
|
53.3 Percentage of Participants
|
—
|
|
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Year 3, Week 24, n=31
|
74.2 Percentage of Participants
|
—
|
|
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Year 3, Week 48, n=28
|
67.9 Percentage of Participants
|
—
|
|
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Year 4, Week 24, n=25
|
88 Percentage of Participants
|
—
|
|
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Year 4, Week 48, n=23
|
73.9 Percentage of Participants
|
—
|
|
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Year 5, Week 24, n=23
|
73.9 Percentage of Participants
|
—
|
|
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Year 5, Week 48, n=22
|
86.4 Percentage of Participants
|
—
|
|
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Year 6, Week 24, n=22
|
77.3 Percentage of Participants
|
—
|
|
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Year 6, Week 48, n=17
|
76.5 Percentage of Participants
|
—
|
|
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Year 7, Week 24, n=14
|
78.6 Percentage of Participants
|
—
|
|
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Year 7, Week 48, n=7
|
71.4 Percentage of Participants
|
—
|
|
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Year 8, Week 24, n=4
|
75 Percentage of Participants
|
—
|
|
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Year 8, Week 48, n=1
|
100 Percentage of Participants
|
—
|
|
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Year 9, Week 24, n=28
|
64.3 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 432Population: MITT Population
B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Observed absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Baseline, n= 262
|
112.5 Cell count
Interval 2.0 to 807.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Yr 1, Wk 24, n= 251
|
68 Cell count
Interval 2.0 to 433.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Yr 1, Wk 48, n= 242
|
50 Cell count
Interval 2.0 to 407.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Yr 2, Wk 24, n= 238
|
37.5 Cell count
Interval 5.0 to 278.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Yr 2, Wk 48, n= 224
|
34 Cell count
Interval 5.0 to 1528.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Yr 3, Wk 24, n= 212
|
31 Cell count
Interval 5.0 to 293.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Yr 3, Wk 48, n= 202
|
26 Cell count
Interval 5.0 to 500.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Yr 4, Wk 24, n= 196
|
27 Cell count
Interval 3.0 to 355.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Yr 4, Wk 48, n= 181
|
23 Cell count
Interval 5.0 to 238.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Yr 5, Wk 24, n= 172
|
22 Cell count
Interval 1.0 to 141.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Yr 5, Wk 48, n= 166
|
18.5 Cell count
Interval 5.0 to 248.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Yr 6, Wk 24, n= 159
|
21 Cell count
Interval 4.0 to 397.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Yr 6, Wk 48, n= 114
|
20 Cell count
Interval 4.0 to 113.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Yr 7, Wk 24, n= 111
|
20 Cell count
Interval 4.0 to 158.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Yr 7, Wk 48, n= 87
|
21 Cell count
Interval 5.0 to 120.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Yr 8, Wk 24, n= 54
|
17 Cell count
Interval 5.0 to 91.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Yr 8, Wk 48, n= 28
|
15.5 Cell count
Interval 5.0 to 57.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Yr 9, Wk 24, n= 2
|
7.5 Cell count
Interval 7.0 to 8.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+, Exit, n= 207
|
22 Cell count
Interval 3.0 to 364.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Baseline, n= 262
|
17 Cell count
Interval 0.0 to 600.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 1, Wk 24, n= 251
|
13 Cell count
Interval 0.0 to 452.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 1, Wk 48, n= 247
|
12 Cell count
Interval 0.0 to 177.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 2, Wk 24, n= 246
|
14 Cell count
Interval 0.0 to 204.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 2, Wk 48, n= 233
|
13 Cell count
Interval 0.0 to 345.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 3, Wk 24, n= 218
|
12 Cell count
Interval 0.0 to 216.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 3, Wk 48, n= 212
|
12 Cell count
Interval 0.0 to 331.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 4, Wk 24, n= 211
|
14 Cell count
Interval 0.0 to 407.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 4, Wk 48, n= 194
|
14 Cell count
Interval 0.0 to 442.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 5, Wk 24, n= 189
|
11 Cell count
Interval 0.0 to 414.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 5, Wk 48, n= 181
|
11 Cell count
Interval 0.0 to 591.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 6, Wk 24, n= 174
|
10.5 Cell count
Interval 0.0 to 443.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 6, Wk 48, n= 133
|
10 Cell count
Interval 0.0 to 248.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 7, Wk 24, n= 122
|
9 Cell count
Interval 0.0 to 381.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 7, Wk 48, n= 97
|
8 Cell count
Interval 0.0 to 156.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 8, Wk 24, n= 60
|
6.5 Cell count
Interval 0.0 to 755.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 8, Wk 48, n= 29
|
5 Cell count
Interval 0.0 to 39.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 9, Wk 24, n= 2
|
17.5 Cell count
Interval 6.0 to 29.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Exit, n= 232
|
9 Cell count
Interval 0.0 to 555.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Baseline, n= 258
|
16 Cell count
Interval 0.0 to 585.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 1, Wk 24, n= 247
|
13 Cell count
Interval 0.0 to 443.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 1, Wk 48, n= 244
|
11 Cell count
Interval 0.0 to 145.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 2, Wk 24, n= 244
|
13 Cell count
Interval 0.0 to 289.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 2, Wk 48, n= 233
|
13 Cell count
Interval 0.0 to 316.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 3, Wk 24, n= 218
|
12 Cell count
Interval 0.0 to 210.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 3, Wk 48, n= 211
|
12 Cell count
Interval 0.0 to 324.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 4, Wk 24, n= 210
|
13 Cell count
Interval 0.0 to 364.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 4, Wk 48, n= 193
|
12 Cell count
Interval 0.0 to 452.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 5, Wk 24, n= 188
|
10.5 Cell count
Interval 0.0 to 377.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 5, Wk 48, n= 181
|
10 Cell count
Interval 0.0 to 597.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 6, Wk 24, n= 174
|
9 Cell count
Interval 0.0 to 400.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 6, Wk 48, n= 133
|
8 Cell count
Interval 0.0 to 227.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 7, Wk 24, n= 122
|
9 Cell count
Interval 0.0 to 328.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 7, Wk 48, n= 97
|
9 Cell count
Interval 0.0 to 156.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 8, Wk 24, n= 60
|
9 Cell count
Interval 0.0 to 754.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 8, Wk 48, n= 29
|
4 Cell count
Interval 0.0 to 42.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 9, Wk 24, n= 2
|
16 Cell count
Interval 4.0 to 28.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Exit, n= 233
|
9 Cell count
Interval 0.0 to 603.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Baseline, n= 261
|
95 Cell count
Interval 0.0 to 4274.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 1, Wk 24, n= 251
|
64 Cell count
Interval 1.0 to 1613.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 1, Wk 48, n= 247
|
37 Cell count
Interval 2.0 to 962.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 2, Wk 24, n= 246
|
32.5 Cell count
Interval 0.0 to 221.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 2, Wk 48, n= 233
|
27 Cell count
Interval 1.0 to 249.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 3, Wk 24, n= 218
|
24 Cell count
Interval 0.0 to 322.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 3, Wk 48, n= 212
|
12 Cell count
Interval 0.0 to 220.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 4, Wk 24, n= 211
|
8 Cell count
Interval 0.0 to 128.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 4, Wk 48, n= 194
|
5 Cell count
Interval 0.0 to 246.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 5, Wk 24, n= 189
|
4 Cell count
Interval 0.0 to 136.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 5, Wk 48, n= 181
|
3 Cell count
Interval 0.0 to 102.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 6, Wk 24, n= 174
|
3 Cell count
Interval 0.0 to 38.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 6, Wk 48, n= 133
|
3 Cell count
Interval 0.0 to 25.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 7, Wk 24, n= 122
|
2 Cell count
Interval 0.0 to 70.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 7, Wk 48, n= 97
|
2 Cell count
Interval 0.0 to 23.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 8, Wk 24, n= 60
|
2 Cell count
Interval 0.0 to 18.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 8, Wk 48, n= 29
|
1 Cell count
Interval 0.0 to 16.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 9, Wk 24, n= 2
|
1 Cell count
Interval 0.0 to 2.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Exit, n= 232
|
3 Cell count
Interval 0.0 to 231.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Baseline, n= 262
|
17 Cell count
Interval 0.0 to 177.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 1, Wk 24, n= 251
|
30 Cell count
Interval 1.0 to 279.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 1, Wk 48, n= 242
|
23 Cell count
Interval 0.0 to 275.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 2, Wk 24, n= 238
|
17 Cell count
Interval 1.0 to 181.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 2, Wk 48, n= 224
|
16 Cell count
Interval 1.0 to 686.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 3, Wk 24, n= 212
|
13 Cell count
Interval 0.0 to 88.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 3, Wk 48, n= 202
|
11 Cell count
Interval 1.0 to 342.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 4, Wk 24, n= 196
|
10.5 Cell count
Interval 1.0 to 276.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 4, Wk 48, n= 181
|
9 Cell count
Interval 1.0 to 196.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 5, Wk 24, n= 172
|
8.5 Cell count
Interval 1.0 to 76.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 5, Wk 48, n= 166
|
7 Cell count
Interval 1.0 to 166.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 6,Wk 24,n=158
|
7 Cell count
Interval 1.0 to 73.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 6, Wk 48, n= 114
|
6 Cell count
Interval 1.0 to 46.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 7, Wk 24, n= 111
|
6 Cell count
Interval 1.0 to 91.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 7, Wk 48, n= 87
|
6 Cell count
Interval 1.0 to 81.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 8, Wk 24, n= 54
|
5 Cell count
Interval 1.0 to 34.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 8, Wk 48, n= 28
|
6 Cell count
Interval 1.0 to 32.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 9, Wk 24, n= 2
|
2 Cell count
Interval 1.0 to 3.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27+Memory, Exit, n= 207
|
8 Cell count
Interval 0.0 to 167.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Baseline, n= 262
|
88 Cell count
Interval 1.0 to 717.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 1, Wk 24, n= 251
|
36 Cell count
Interval 1.0 to 371.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 1, Wk 48, n= 242
|
25 Cell count
Interval 1.0 to 209.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 2, Wk 24, n= 238
|
21 Cell count
Interval 2.0 to 176.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 2, Wk 48, n= 224
|
17 Cell count
Interval 1.0 to 826.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 3, Wk 24, n= 212
|
16 Cell count
Interval 1.0 to 243.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 3, Wk 48, n= 202
|
14 Cell count
Interval 1.0 to 163.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 4, Wk 24, n= 196
|
15 Cell count
Interval 2.0 to 140.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 4, Wk 48, n= 181
|
12 Cell count
Interval 1.0 to 152.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 5, Wk 24, n= 172
|
12.5 Cell count
Interval 0.0 to 127.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 5, Wk 48, n= 166
|
11 Cell count
Interval 2.0 to 176.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 6, Wk 24, n= 159
|
12 Cell count
Interval 0.0 to 67.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 6, Wk 48, n= 114
|
13 Cell count
Interval 1.0 to 68.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 7, Wk 24, n= 111
|
13 Cell count
Interval 1.0 to 69.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 7, Wk 48, n= 87
|
12 Cell count
Interval 2.0 to 59.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 8, Wk 24, n= 54
|
11.5 Cell count
Interval 2.0 to 62.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 8, Wk 48, n= 28
|
12 Cell count
Interval 2.0 to 54.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 9, Wk 24, n= 2
|
5.5 Cell count
Interval 4.0 to 7.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/27-naive, Exit, n= 207
|
13 Cell count
Interval 1.0 to 313.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Baseline, n= 257
|
190 Cell count
Interval 11.0 to 2492.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 1, Wk 24, n= 247
|
131 Cell count
Interval 7.0 to 1503.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 1, Wk 48, n= 244
|
82 Cell count
Interval 1.0 to 561.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 2, Wk 24, n= 244
|
74 Cell count
Interval 0.0 to 916.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 2, Wk 48, n= 233
|
56 Cell count
Interval 0.0 to 472.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 3, Wk 24, n= 218
|
31 Cell count
Interval 0.0 to 242.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 3, Wk 48, n= 211
|
22 Cell count
Interval 0.0 to 233.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 4, Wk 24, n= 210
|
13 Cell count
Interval 0.0 to 687.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 4, Wk 48, n= 193
|
8 Cell count
Interval 0.0 to 288.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 5, Wk 24, n= 188
|
6 Cell count
Interval 0.0 to 147.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 5, Wk 48, n= 181
|
4 Cell count
Interval 0.0 to 61.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 6, Wk 24, n= 174
|
4 Cell count
Interval 0.0 to 40.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 6, Wk 48, n= 133
|
3 Cell count
Interval 0.0 to 56.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 7, Wk 24, n= 122
|
3 Cell count
Interval 0.0 to 43.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 7, Wk 48, n= 97
|
2 Cell count
Interval 0.0 to 29.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 8, Wk 24, n= 60
|
1.5 Cell count
Interval 0.0 to 21.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 8, Wk 48, n= 29
|
1 Cell count
Interval 0.0 to 10.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 9, Wk 24, n= 2
|
0.5 Cell count
Interval 0.0 to 1.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20+/69+activated, Exit, n= 233
|
2 Cell count
Interval 0.0 to 457.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Baseline, n= 261
|
41 Cell count
Interval 1.0 to 870.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 1, Wk 24, n= 251
|
31 Cell count
Interval 0.0 to 393.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 1, Wk 48, n= 247
|
24 Cell count
Interval 0.0 to 255.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 2, Wk 24, n= 246
|
23 Cell count
Interval 0.0 to 446.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 2, Wk 48, n= 233
|
20 Cell count
Interval 0.0 to 1513.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 3, Wk 24, n= 218
|
19 Cell count
Interval 0.0 to 312.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 3, Wk 48, n= 212
|
16 Cell count
Interval 0.0 to 225.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 4, Wk 24, n= 211
|
14 Cell count
Interval 0.0 to 337.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 4, Wk 48, n= 194
|
7.5 Cell count
Interval 0.0 to 214.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 5, Wk 24, n= 189
|
6 Cell count
Interval 0.0 to 135.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 5, Wk 48, n= 181
|
6 Cell count
Interval 0.0 to 75.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 6, Wk 24, n= 174
|
4 Cell count
Interval 0.0 to 50.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 6, Wk 48, n= 133
|
4 Cell count
Interval 0.0 to 64.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 7, Wk 24, n= 122
|
4.5 Cell count
Interval 0.0 to 84.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 7, Wk 48, n= 97
|
4 Cell count
Interval 0.0 to 47.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 8, Wk 24, n= 60
|
3 Cell count
Interval 0.0 to 75.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 8, Wk 48, n= 29
|
2 Cell count
Interval 0.0 to 28.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 9, Wk 24, n= 2
|
8 Cell count
Interval 2.0 to 14.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Exit, n= 232
|
5 Cell count
Interval 0.0 to 221.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Baseline, n= 265
|
114 Cell count
Interval 4.0 to 815.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 1, Wk 24, n= 253
|
69 Cell count
Interval 4.0 to 437.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 1, Wk 48, n= 254
|
49 Cell count
Interval 4.0 to 411.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 2, Wk 24, n= 247
|
37 Cell count
Interval 4.0 to 281.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 2, Wk 48, n= 234
|
34 Cell count
Interval 4.0 to 1559.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 3, Wk 24, n= 220
|
30 Cell count
Interval 4.0 to 296.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 3, Wk 48, n= 212
|
26 Cell count
Interval 4.0 to 510.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 4, Wk 24, n= 211
|
25 Cell count
Interval 4.0 to 359.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 4, Wk 48, n= 195
|
22 Cell count
Interval 4.0 to 245.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 5, Wk 24, n= 190
|
19 Cell count
Interval 4.0 to 144.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 5, Wk 48, n= 182
|
18 Cell count
Interval 4.0 to 301.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 6, Wk 24, n= 175
|
19 Cell count
Interval 4.0 to 117.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 6, Wk 48, n= 132
|
17.5 Cell count
Interval 4.0 to 114.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 7, Wk 24, n= 122
|
18.5 Cell count
Interval 4.0 to 160.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 7, Wk 48, n= 97
|
19 Cell count
Interval 4.0 to 121.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 8, Wk 24, n= 60
|
16.5 Cell count
Interval 4.0 to 92.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 8, Wk 48, n= 29
|
15 Cell count
Interval 4.0 to 58.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 9, Wk 24, n= 2
|
7.5 Cell count
Interval 7.0 to 8.0
|
—
|
|
Observed B-cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Exit, n= 234
|
20 Cell count
Interval 4.0 to 368.0
|
—
|
SECONDARY outcome
Timeframe: Up to Week 432Population: MITT Population
B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Median percent change from Baseline in absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x (\[Post-Dose Visit Value - Baseline\] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 1, Wk 48, n= 237
|
-69.7 Percentage change
Interval -96.7 to 200.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 2, Wk 24, n= 233
|
-77.27 Percentage change
Interval -97.6 to 150.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 2, Wk 48, n= 218
|
-79.5 Percentage change
Interval -98.6 to 959.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 3, Wk 24, n= 206
|
-80.11 Percentage change
Interval -98.5 to 100.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 3, Wk 48, n= 196
|
-84.41 Percentage change
Interval -98.5 to 500.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 4, Wk 24, n= 191
|
-81.93 Percentage change
Interval -98.8 to 100.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 4, Wk 48, n= 175
|
-84.21 Percentage change
Interval -98.8 to 100.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 5, Wk 24, n= 166
|
-86.09 Percentage change
Interval -100.0 to 66.7
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 5, Wk 48, n= 161
|
-87.5 Percentage change
Interval -99.2 to 57.7
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 6, Wk 24, n= 154
|
-86.88 Percentage change
Interval -100.0 to 233.3
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 6, Wk 48, n= 109
|
-86.93 Percentage change
Interval -97.7 to 100.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 7, Wk 24, n= 107
|
-87.39 Percentage change
Interval -98.4 to 300.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 7, Wk 48, n= 82
|
-84.78 Percentage change
Interval -98.0 to 300.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 8, Wk 24, n= 52
|
-83.7 Percentage change
Interval -97.9 to 510.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 8, Wk 48, n= 27
|
-88.15 Percentage change
Interval -96.5 to 86.7
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 9, Wk 24, n= 2
|
-61.93 Percentage change
Interval -87.5 to -36.4
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Exit, n= 203
|
-86.42 Percentage change
Interval -99.0 to 433.3
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 1, Wk 24, n= 240
|
-33.35 Percentage change
Interval -98.5 to 3000.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 1, Wk 48, n= 238
|
-56.33 Percentage change
Interval -99.7 to 1331.6
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 2, Wk 24, n= 236
|
-65.21 Percentage change
Interval -100.0 to 580.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 2, Wk 48, n= 223
|
-72.31 Percentage change
Interval -100.0 to 502.9
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 3, Wk 24, n= 208
|
-83.71 Percentage change
Interval -100.0 to 306.9
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 3, Wk 48, n= 202
|
-89.28 Percentage change
Interval -100.0 to 325.7
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 4, Wk 24, n= 201
|
-93.14 Percentage change
Interval -100.0 to 89.3
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 4, Wk 48, n= 185
|
-94.85 Percentage change
Interval -100.0 to 263.6
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 5, Wk 24, n= 180
|
-96.99 Percentage change
Interval -100.0 to 13.4
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 5, Wk 48, n= 172
|
-98.04 Percentage change
Interval -100.0 to 14.3
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 6, Wk 24, n= 165
|
-98.04 Percentage change
Interval -100.0 to -16.7
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 6, Wk 48, n= 125
|
-98.76 Percentage change
Interval -100.0 to 20.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 7, Wk 24, n= 116
|
-98.85 Percentage change
Interval -100.0 to -24.1
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 7, Wk 48, n=89
|
-99.22 Percentage change
Interval -100.0 to -76.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 8, Wk 24, n= 56
|
-99.33 Percentage change
Interval -100.0 to -83.7
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 8, Wk 48, n= 28
|
-99.71 Percentage change
Interval -100.0 to -95.8
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Yr 9, Wk 24, n= 2
|
-97.92 Percentage change
Interval -100.0 to -95.8
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/69+activated, Exit, n= 226
|
-98.99 Percentage change
Interval -100.0 to 453.1
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 1, Wk 24, n= 244
|
-37.2 Percentage change
Interval -100.0 to 3400.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 1, Wk 48, n= 241
|
-50 Percentage change
Interval -100.0 to 4700.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 2, Wk 24, n= 240
|
-47.83 Percentage change
Interval -100.0 to 1200.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 2, Wk 48, n= 226
|
-53.92 Percentage change
Interval -100.0 to 5500.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 3, Wk 24, n= 212
|
-64.82 Percentage change
Interval -100.0 to 1000.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 3, Wk 48, n= 205
|
-71.43 Percentage change
Interval -100.0 to 2566.7
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 4, Wk 24, n= 205
|
-73.76 Percentage change
Interval -100.0 to 910.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 4, Wk 48, n= 187
|
-81.58 Percentage change
Interval -100.0 to 586.4
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 5, Wk 24, n= 182
|
-86.46 Percentage change
Interval -100.0 to 133.3
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 5, Wk 48, n= 175
|
-88.89 Percentage change
Interval -100.0 to 300.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 6, Wk 24, n= 168
|
-91.3 Percentage change
Interval -100.0 to 900.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 6, Wk 48, n= 127
|
-90.91 Percentage change
Interval -100.0 to 2100.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 7, Wk 24, n= 118
|
-92.31 Percentage change
Interval -100.0 to 1700.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 7, Wk 48, n= 92
|
-93.83 Percentage change
Interval -100.0 to 200.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 8, Wk 24, n= 57
|
-93.39 Percentage change
Interval -100.0 to -11.1
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 8, Wk 48, n= 28
|
-97.56 Percentage change
Interval -100.0 to -75.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Yr 9, Wk 24, n= 2
|
-80.78 Percentage change
Interval -90.1 to -71.4
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20-/138+plasma cells, Exit, n= 226
|
-88.58 Percentage change
Interval -100.0 to 1600.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 1, Wk 24, n= 250
|
-32.56 Percentage change
Interval -91.7 to 400.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 1, Wk 48, n= 251
|
-51.61 Percentage change
Interval -94.6 to 214.3
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 2, Wk 24, n= 244
|
-61.71 Percentage change
Interval -95.5 to 244.4
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 2, Wk 48, n= 231
|
-66.67 Percentage change
Interval -96.0 to 1576.3
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 3, Wk 24, n= 217
|
-70.21 Percentage change
Interval -96.3 to 153.3
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 3, Wk 48, n= 209
|
-74.24 Percentage change
Interval -97.3 to 276.5
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 4, Wk 24, n= 209
|
-75.61 Percentage change
Interval -97.8 to 82.4
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 4, Wk 48, n= 192
|
-78.54 Percentage change
Interval -97.8 to 528.2
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 5, Wk 24, n= 187
|
-80.56 Percentage change
Interval -97.8 to 141.2
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 5, Wk 48, n= 179
|
-81.14 Percentage change
Interval -98.1 to 100.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 6, Wk 24, n= 172
|
-81.85 Percentage change
Interval -98.1 to 75.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 6, Wk 48, n= 130
|
-82.34 Percentage change
Interval -98.5 to 79.5
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 7, Wk 24, n= 120
|
-82.73 Percentage change
Interval -97.6 to 125.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 7, Wk 48, n= 95
|
-80.95 Percentage change
Interval -97.8 to 172.2
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 8, Wk 24, n= 59
|
-79.87 Percentage change
Interval -96.9 to 250.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 8, Wk 48, n= 28
|
-84.79 Percentage change
Interval -95.6 to 94.4
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Yr 9, Wk 24, n= 2
|
-66.04 Percentage change
Interval -85.4 to -46.7
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Total CD19+ B-cells (CD19+), Exit, n= 232
|
-80.81 Percentage change
Interval -98.2 to 178.6
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Yr 1, Wk 24, n= 245
|
-31.82 Percentage change
Interval -91.9 to 394.1
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Yr 1, Wk 48, n= 237
|
-51.61 Percentage change
Interval -94.7 to 216.7
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Yr 2, Wk 24, n= 233
|
-61.76 Percentage change
Interval -95.4 to 250.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Yr 2, Wk 48, n= 218
|
-66.21 Percentage change
Interval -96.3 to 1616.9
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Yr 3, Wk 24, n= 206
|
-69.68 Percentage change
Interval -96.2 to 250.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Yr 3, Wk 48, n= 196
|
-72.77 Percentage change
Interval -97.3 to 270.6
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Yr 4, Wk 24, n= 191
|
-75.16 Percentage change
Interval -96.8 to 82.4
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Yr 4, Wk 48, n= 175
|
-78.33 Percentage change
Interval -97.6 to 561.1
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Yr 5, Wk 24, n= 166
|
-80.26 Percentage change
Interval -97.6 to 156.3
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Yr 5, Wk 48, n= 161
|
-81.06 Percentage change
Interval -98.1 to 93.8
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Yr 6, Wk 24, n= 154
|
-81.87 Percentage change
Interval -98.1 to 2381.3
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Yr 6, Wk 48, n= 109
|
-82.94 Percentage change
Interval -96.7 to 102.9
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Yr 7, Wk 24, n= 107
|
-83.22 Percentage change
Interval -97.6 to 188.9
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Yr 7, Wk 48, n= 82
|
-80.96 Percentage change
Interval -97.3 to 172.2
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Yr 8, Wk 24, n= 52
|
-78.94 Percentage change
Interval -96.9 to 244.4
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Yr 8, Wk 48, n= 27
|
-85.29 Percentage change
Interval -95.5 to 105.9
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Yr 9, Wk 24, n= 2
|
-63.65 Percentage change
Interval -84.4 to -42.9
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+, Exit, n= 203
|
-80.6 Percentage change
Interval -98.2 to 225.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 1, Wk 24, n= 243
|
-16.13 Percentage change
Interval -100.0 to 4500.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 1, Wk 48, n= 240
|
-38.74 Percentage change
Interval -100.0 to 4800.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 2, Wk 24, n= 239
|
-25 Percentage change
Interval -100.0 to 2200.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 2, Wk 48, n= 225
|
-26.23 Percentage change
Interval -100.0 to 33100.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 3, Wk 24, n= 210
|
-33.97 Percentage change
Interval -100.0 to 6800.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 3, Wk 48, n= 204
|
-37.98 Percentage change
Interval -100.0 to 4900.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 4, Wk 24, n= 204
|
-19.52 Percentage change
Interval -100.0 to 2787.5
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 4, Wk 48, n= 187
|
-16.67 Percentage change
Interval -100.0 to 5500.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 5, Wk 24, n= 182
|
-33.33 Percentage change
Interval -100.0 to 4900.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 5, Wk 48, n= 174
|
-37.46 Percentage change
Interval -100.0 to 10000.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 6, Wk 24, n= 167
|
-44.44 Percentage change
Interval -100.0 to 11100.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 6, Wk 48, n= 126
|
-50 Percentage change
Interval -100.0 to 24700.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 7, Wk 24, n= 117
|
-50 Percentage change
Interval -100.0 to 29300.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 7, Wk 48, n= 92
|
-70.76 Percentage change
Interval -100.0 to 2100.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 8, Wk 24, n= 57
|
-71.43 Percentage change
Interval -100.0 to 1787.5
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 8, Wk 48, n= 28
|
-85 Percentage change
Interval -100.0 to 100.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Yr 9, Wk 24, n= 2
|
210.98 Percentage change
Interval -78.0 to 500.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+/27BRIGHT/38BRIGHT SLE, Exit, n= 226
|
-50 Percentage change
Interval -100.0 to 6100.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 1, Wk 24, n= 238
|
-32.29 Percentage change
Interval -100.0 to 4330.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 1, Wk 48, n= 235
|
-40 Percentage change
Interval -100.0 to 1400.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 2, Wk 24, n= 234
|
-27.05 Percentage change
Interval -100.0 to 2000.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 2, Wk 48, n= 221
|
-30 Percentage change
Interval -100.0 to 4385.7
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 3, Wk 24, n= 207
|
-37.5 Percentage change
Interval -100.0 to 1300.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 3, Wk 48, n= 199
|
-40.54 Percentage change
Interval -100.0 to 6600.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 4, Wk 24, n= 199
|
-29.41 Percentage change
Interval -100.0 to 1900.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 4, Wk 48, n= 184
|
-29.29 Percentage change
Interval -100.0 to 1250.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 5, Wk 24, n= 178
|
-44.6 Percentage change
Interval -100.0 to 1400.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 5, Wk 48, n= 171
|
-45.65 Percentage change
Interval -100.0 to 1328.6
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 6, Wk 24, n= 165
|
-62.5 Percentage change
Interval -100.0 to 3400.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 6, Wk 48, n= 123
|
-62.5 Percentage change
Interval -100.0 to 3400.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 7, Wk 24, n= 114
|
-47.5 Percentage change
Interval -100.0 to 4128.6
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 7, Wk 48, n= 89
|
-58.33 Percentage change
Interval -100.0 to 2900.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 8, Wk 24, n= 55
|
-62.07 Percentage change
Interval -100.0 to 1884.2
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 8, Wk 48, n= 27
|
-84.62 Percentage change
Interval -100.0 to 10.5
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Yr 9, Wk 24, n= 1
|
-79.4 Percentage change
Interval -79.4 to -79.4
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD19+20-27hi+ SLPC, Exit, n= 224
|
-51.42 Percentage change
Interval -100.0 to 2000.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 1, Wk 24, n= 243
|
-32.49 Percentage change
Interval -97.4 to 6352.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 1, Wk 48, n= 240
|
-61.11 Percentage change
Interval -99.0 to 923.4
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 2, Wk 24, n= 239
|
-66 Percentage change
Interval -100.0 to 2233.3
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 2, Wk 48, n= 225
|
-70.64 Percentage change
Interval -99.2 to 422.2
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 3, Wk 24, n= 211
|
-78.57 Percentage change
Interval -100.0 to 644.4
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 3, Wk 48, n= 204
|
-88.89 Percentage change
Interval -100.0 to 863.6
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 4, Wk 24, n= 204
|
-93.14 Percentage change
Interval -100.0 to 156.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 4, Wk 48, n= 186
|
-94.17 Percentage change
Interval -100.0 to 35.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 5, Wk 24, n= 181
|
-96.25 Percentage change
Interval -100.0 to 33.3
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 5, Wk 48, n= 174
|
-96.75 Percentage change
Interval -100.0 to -21.2
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 6, Wk 24, n= 167
|
-96.53 Percentage change
Interval -100.0 to -9.1
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 6, Wk 48, n= 126
|
-97.96 Percentage change
Interval -100.0 to -36.4
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 7, Wk 24, n= 117
|
-98 Percentage change
Interval -100.0 to -33.3
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 7, Wk 48, n= 91
|
-98.46 Percentage change
Interval -100.0 to -40.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 8, Wk 24, n= 57
|
-98.64 Percentage change
Interval -100.0 to -70.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 8, Wk 48, n= 28
|
-98.68 Percentage change
Interval -100.0 to -92.9
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Yr 9, Wk 24, n= 2
|
-96.15 Percentage change
Interval -100.0 to -92.3
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/138+ plasmacytoid, Exit, n= 225
|
-96.83 Percentage change
Interval -100.0 to 610.7
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 1, Wk 24, n= 244
|
87.65 Percentage change
Interval -97.1 to 1420.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 1, Wk 48, n= 237
|
42.86 Percentage change
Interval -100.0 to 800.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 2, Wk 24, n= 233
|
11.11 Percentage change
Interval -88.9 to 700.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 2, Wk 48, n= 217
|
-7.69 Percentage change
Interval -84.6 to 5616.7
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 3, Wk 24, n= 205
|
-23.26 Percentage change
Interval -100.0 to 900.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 3, Wk 48, n= 196
|
-35.29 Percentage change
Interval -97.1 to 3000.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 4, Wk 24, n= 191
|
-40 Percentage change
Interval -92.6 to 1400.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 4, Wk 48, n= 175
|
-50 Percentage change
Interval -92.3 to 3166.7
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 5, Wk 24, n= 166
|
-50 Percentage change
Interval -97.7 to 500.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 5, Wk 48, n= 160
|
-58.87 Percentage change
Interval -96.0 to 800.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 6, Wk 24, n= 153
|
-57.89 Percentage change
Interval -96.2 to 533.3
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 6, Wk 48, n= 108
|
-63.4 Percentage change
Interval -92.9 to 400.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 7, Wk 24, n= 106
|
-67.18 Percentage change
Interval -96.2 to 500.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 7, Wk 48, n= 81
|
-71.43 Percentage change
Interval -92.3 to 400.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 8, Wk 24, n= 52
|
-67.03 Percentage change
Interval -96.0 to 200.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 8, Wk 48, n= 27
|
-64.71 Percentage change
Interval -88.8 to 600.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Yr 9, Wk 24, n= 2
|
-75.96 Percentage change
Interval -76.9 to -75.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27+Memory, Exit, n= 202
|
-61.41 Percentage change
Interval -100.0 to 1000.0
|
—
|
|
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
CD20+/27-naive, Yr 1, Wk 24, n= 245
|
-55.56 Percentage change
Interval -95.1 to 337.5
|
—
|
SECONDARY outcome
Timeframe: Up to Week 384Population: MITT Population
Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index is a tool used to assess non-reversible organ damage in SLE patients. Damage Index is used to assess 12 systems by 41 items. Score is given as 1 or sometimes 2, if occur more than once, so that that the maximum possible score is 47. Higher damage index scores early in disease are associated with a poor prognosis and with increased mortality. Damage index was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. Percentage of participants with worsening in damage index (change \>0) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points were analyzed ( n=X).
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points
Year 1, Week 48, n=263
|
5.7 Percentage of Participants
|
—
|
|
Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points
Year 2, Week 48, n=256
|
12.1 Percentage of Participants
|
—
|
|
Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points
Year 3, Week 48, n=239
|
18 Percentage of Participants
|
—
|
|
Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points
Year 4, Week 48, n=212
|
20.8 Percentage of Participants
|
—
|
|
Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points
Year 5, Week 48, n=195
|
22.6 Percentage of Participants
|
—
|
|
Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points
Year 6, Week 48, n=187
|
25.1 Percentage of Participants
|
—
|
|
Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points
Year 7, Week 48, n=126
|
30.2 Percentage of Participants
|
—
|
|
Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points
Year 8, Week 48, n=65
|
29.2 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 384Population: MITT Population
The SF-36v2 is a participant-reported short form survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
MCS, Year 1, Week 48, n= 259
|
2.47 Score on a scale
Standard Deviation 10.113
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
MCS, Year 2, Week 48, n= 255
|
2.99 Score on a scale
Standard Deviation 10.428
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
MCS, Year 3, Week 48, n= 236
|
2.54 Score on a scale
Standard Deviation 10.399
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
MCS, Year 4, Week 48, n= 212
|
2.52 Score on a scale
Standard Deviation 11.099
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
MCS, Year 5, Week 48, n= 193
|
2.22 Score on a scale
Standard Deviation 11.22
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
MCS, Year 6, Week 48, n= 185
|
2.71 Score on a scale
Standard Deviation 11.274
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
MCS, Year 7, Week 48, n= 126
|
3.19 Score on a scale
Standard Deviation 11.269
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
MCS, Year 8, Week 48, n= 65
|
3.91 Score on a scale
Standard Deviation 11.066
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
PCS, Year 1, Week 48, n= 259
|
3.41 Score on a scale
Standard Deviation 8.603
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
PCS, Year 2, Week 48, n= 255
|
4.64 Score on a scale
Standard Deviation 8.3
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
PCS, Year 3, Week 48, n= 236
|
5.93 Score on a scale
Standard Deviation 8.51
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
PCS, Year 4, Week 48, n= 212
|
5.01 Score on a scale
Standard Deviation 8.752
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
PCS, Year 5, Week 48, n= 193
|
6.12 Score on a scale
Standard Deviation 9.314
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
PCS, Year 6, Week 48, n= 185
|
4.79 Score on a scale
Standard Deviation 9.406
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
PCS, Year 7, Week 48, n= 126
|
7.7 Score on a scale
Standard Deviation 9.887
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
PCS, Year 8, Week 48, n= 65
|
6.73 Score on a scale
Standard Deviation 10.107
|
—
|
SECONDARY outcome
Timeframe: Up to Week 384Population: MITT Population
The SF-36v2 is a participant-reported survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Bodily pain, Year 1 , Week 48, n= 261
|
9.7 Score on a scale
Standard Deviation 23.36
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Bodily pain, Year 2 , Week 48, n= 255
|
9.2 Score on a scale
Standard Deviation 24.389
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Bodily pain, Year 3 , Week 48, n= 236
|
10.97 Score on a scale
Standard Deviation 23.409
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Bodily pain, Year 4 , Week 48, n= 212
|
8.33 Score on a scale
Standard Deviation 24.181
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Bodily pain, Year 5 , Week 48, n= 193
|
10.88 Score on a scale
Standard Deviation 24.549
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Bodily pain, Year 6 , Week 48, n= 185
|
8.82 Score on a scale
Standard Deviation 23.636
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Bodily pain, Year 7 , Week 48, n= 126
|
14.48 Score on a scale
Standard Deviation 24.969
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Bodily pain, Year 8 , Week 48, n= 65
|
11.94 Score on a scale
Standard Deviation 22.93
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
General health, Year 1 , Week 48, n= 260
|
5.66 Score on a scale
Standard Deviation 14.693
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
General health, Year 2 , Week 48, n= 255
|
6.14 Score on a scale
Standard Deviation 15.156
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
General health, Year 3 , Week 48, n= 236
|
8.84 Score on a scale
Standard Deviation 15.929
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
General health, Year 4 , Week 48, n= 212
|
7.29 Score on a scale
Standard Deviation 16.069
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
General health, Year 5 , Week 48, n= 193
|
9.19 Score on a scale
Standard Deviation 17.742
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
General health, Year 6 , Week 48, n= 185
|
7.24 Score on a scale
Standard Deviation 18.187
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
General health, Year 7 , Week 48, n= 126
|
8.71 Score on a scale
Standard Deviation 18.693
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
General health, Year 8 , Week 48, n= 65
|
8.18 Score on a scale
Standard Deviation 19.994
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Mental health, Year 1 , Week 48, n= 260
|
4 Score on a scale
Standard Deviation 17.71
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Mental health, Year 2 , Week 48, n= 255
|
3.62 Score on a scale
Standard Deviation 17.46
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Mental health, Year 3 , Week 48, n= 236
|
2.34 Score on a scale
Standard Deviation 17.817
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Mental health, Year 4 , Week 48, n= 212
|
2.33 Score on a scale
Standard Deviation 20.172
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Mental health, Year 5 , Week 48, n= 193
|
1.78 Score on a scale
Standard Deviation 20.662
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Mental health, Year 6 , Week 48, n= 185
|
3.6 Score on a scale
Standard Deviation 19.968
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Mental health, Year 7 , Week 48, n= 126
|
4.39 Score on a scale
Standard Deviation 19.811
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Mental health, Year 8 , Week 48, n= 65
|
6.08 Score on a scale
Standard Deviation 18.551
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Physical functioning, Year 1 , Week 48, n= 260
|
6.34 Score on a scale
Standard Deviation 21.498
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Physical functioning, Year 2 , Week 48, n= 255
|
6.25 Score on a scale
Standard Deviation 21.185
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Physical functioning, Year 3 , Week 48, n= 236
|
7.85 Score on a scale
Standard Deviation 21.994
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Physical functioning, Year 4 , Week 48, n= 212
|
6.38 Score on a scale
Standard Deviation 22.112
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Physical functioning, Year 5 , Week 48, n= 193
|
7.62 Score on a scale
Standard Deviation 24.486
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Physical functioning, Year 6 , Week 48, n= 185
|
6.72 Score on a scale
Standard Deviation 24.81
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Physical functioning, Year 7 , Week 48, n= 126
|
11.25 Score on a scale
Standard Deviation 26.422
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Physical functioning, Year 8 , Week 48, n= 65
|
11.83 Score on a scale
Standard Deviation 27.065
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Role emotional, Year 1 , Week 48, n= 261
|
4.96 Score on a scale
Standard Deviation 25.714
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Role emotional, Year 2 , Week 48, n= 254
|
4.74 Score on a scale
Standard Deviation 27.92
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Role emotional, Year 3 , Week 48, n= 236
|
3.73 Score on a scale
Standard Deviation 28.258
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Role emotional, Year 4 , Week 48, n= 212
|
3.32 Score on a scale
Standard Deviation 28.237
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Role emotional, Year 5 , Week 48, n= 193
|
3.61 Score on a scale
Standard Deviation 28.774
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Role emotional, Year 6 , Week 48, n= 185
|
3.13 Score on a scale
Standard Deviation 31.614
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Role emotional, Year 7 , Week 48, n= 126
|
3.27 Score on a scale
Standard Deviation 30.385
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Role emotional, Year 8 , Week 48, n=65
|
7.18 Score on a scale
Standard Deviation 33.91
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Role physical, Year 1 , Week 48, n= 260
|
8.91 Score on a scale
Standard Deviation 26.393
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Role physical, Year 2 , Week 48, n= 253
|
8 Score on a scale
Standard Deviation 27.106
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Role physical, Year 3 , Week 48, n= 236
|
10.05 Score on a scale
Standard Deviation 26.525
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Role physical, Year 4 , Week 48, n= 212
|
8.27 Score on a scale
Standard Deviation 28.998
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Role physical, Year 5 , Week 48, n= 193
|
10.86 Score on a scale
Standard Deviation 29.839
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Role physical, Year 6 , Week 48, n= 185
|
6.91 Score on a scale
Standard Deviation 30.995
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Role physical, Year 7 , Week 48, n= 126
|
13.53 Score on a scale
Standard Deviation 31.347
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Role physical, Year 8 , Week 48, n= 65
|
11.51 Score on a scale
Standard Deviation 34.385
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Social functioning, Year 1 , Week 48, n= 261
|
7.61 Score on a scale
Standard Deviation 26.901
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Social functioning, Year 2 , Week 48, n= 255
|
7.21 Score on a scale
Standard Deviation 27.218
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Social functioning, Year 3 , Week 48, n= 236
|
9.59 Score on a scale
Standard Deviation 27.989
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Social functioning, Year 4 , Week 48, n= 212
|
6.9 Score on a scale
Standard Deviation 28.598
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Social functioning, Year 5 , Week 48, n= 193
|
8.16 Score on a scale
Standard Deviation 30.079
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Social functioning, Year 6 , Week 48, n= 185
|
6.96 Score on a scale
Standard Deviation 28.695
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Social functioning, Year 7 , Week 48, n= 126
|
10.32 Score on a scale
Standard Deviation 31.784
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Social functioning, Year 8 , Week 48, n= 65
|
9.81 Score on a scale
Standard Deviation 32.135
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Vitality, Year 1 , Week 48, n= 260
|
8.87 Score on a scale
Standard Deviation 21.449
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Vitality, Year 2 , Week 48, n= 255
|
7.13 Score on a scale
Standard Deviation 22.287
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Vitality, Year 3 , Week 48, n= 236
|
8.17 Score on a scale
Standard Deviation 20.742
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Vitality, Year 4 , Week 48, n= 212
|
8.04 Score on a scale
Standard Deviation 21.742
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Vitality, Year 5 , Week 48, n= 193
|
8.23 Score on a scale
Standard Deviation 24.937
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Vitality, Year 6 , Week 48, n= 185
|
6.93 Score on a scale
Standard Deviation 23.023
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Vitality, Year 7 , Week 48, n= 126
|
11.69 Score on a scale
Standard Deviation 22.709
|
—
|
|
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Vitality, Year 8 , Week 48, n= 65
|
6.47 Score on a scale
Standard Deviation 22.033
|
—
|
SECONDARY outcome
Timeframe: Up to Week 384Population: MITT Population
The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Wk 48 in first year, at Wk 48 in subsequent Yrs up to 8 Yrs.The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Change from BL in FACIT-Fatigue scale total score are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. A negative change from BL represents a worsening condition. Only those participants available at the specified time points were analyzed ( n=X).
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point
Year 1, Week 48, n= 260
|
4.91 Score on a scale
Standard Deviation 10.785
|
—
|
|
Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point
Year 2, Week 48, n= 252
|
4.82 Score on a scale
Standard Deviation 11.414
|
—
|
|
Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point
Year 3, Week 48, n= 235
|
4.85 Score on a scale
Standard Deviation 11.614
|
—
|
|
Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point
Year 4, Week 48, n= 210
|
4.14 Score on a scale
Standard Deviation 11.269
|
—
|
|
Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point
Year 5, Week 48, n= 193
|
4.81 Score on a scale
Standard Deviation 11.962
|
—
|
|
Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point
Year 6, Week 48, n= 184
|
3.7 Score on a scale
Standard Deviation 11.787
|
—
|
|
Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point
Year 7, Week 48, n= 126
|
5.74 Score on a scale
Standard Deviation 11.644
|
—
|
|
Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point
Year 8, Week 48, n= 65
|
4.28 Score on a scale
Standard Deviation 10.949
|
—
|
SECONDARY outcome
Timeframe: Up to Week 384Population: MITT Population
The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Percentage of participants with improvement in FACIT-Fatigue scale score exceeding the minimum clinically important difference (MCID) (\>=4 points) are summarized. Only those participants available at the specified time points were analyzed ( n=X).
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=268 Participants
Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
Belimumab 10 mg/kg IV (Belimumab)
Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|---|
|
Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points
Year 1, Week 48
|
50.4 Percentage of Participants
|
—
|
|
Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points
Year 2, Week 48
|
45.9 Percentage of Participants
|
—
|
|
Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points
Year 3, Week 48
|
44.4 Percentage of Participants
|
—
|
|
Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points
Year 4, Week 48
|
36.2 Percentage of Participants
|
—
|
|
Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points
Year 5, Week 48
|
40.3 Percentage of Participants
|
—
|
|
Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points
Year 6, Week 48
|
33.2 Percentage of Participants
|
—
|
|
Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points
Year 7, Week 48
|
26.1 Percentage of Participants
|
—
|
|
Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points
Year 8, Week 48
|
13.1 Percentage of Participants
|
—
|
Adverse Events
Belimumab 10 mg/kg IV
Serious events: 112 serious events
Other events: 266 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Belimumab 10 mg/kg IV
n=268 participants at risk
Belimumab 10 mg/kg IV every 28 days
|
|---|---|
|
Infections and infestations
Any event
|
16.4%
44/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Cellulitis
|
2.6%
7/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
1.9%
5/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia bacterial
|
1.9%
5/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis viral
|
1.1%
3/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia viral
|
1.1%
3/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Bronchitis bacterial
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Septic shock
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Appendicitis
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Arthritis bacterial
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Arthritis infective
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Atypical pneumonia
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Bacterial sepsis
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Bronchiolitis
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Cellulitis streptococcal
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Fungal skin infection
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Genital herpes
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Herpes zoster
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Infected dermal cyst
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Infected skin ulcer
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Lobar pneumonia
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Oral candidiasis
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pelvic abscess
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Perinephric abscess
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pyelonephritis
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Staphylococcal infection
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Streptococcal urinary tract infection
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Sweat gland infection
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Any event
|
8.2%
22/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.5%
4/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
3/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Any event
|
7.5%
20/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
4.5%
12/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
1.9%
5/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Chest pain
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Asthenia
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Chest discomfort
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Oedema
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Oedema peripheral
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Any event
|
7.1%
19/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
3/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
3/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Food poisoning
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Ileus
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Any event
|
5.6%
15/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
1.1%
3/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Wound
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Any event
|
5.6%
15/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Syncope
|
1.5%
4/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
1.1%
3/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Hypoaesthesia
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Paraesthesia
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Amnesia
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Convulsion
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Loss of consciousness
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Migraine
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any event
|
4.9%
13/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oestrogen receptor positive breast cancer
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Any event
|
4.1%
11/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
3/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Any event
|
3.7%
10/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
1.1%
3/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Hypertensive crisis
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Hypotension
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Lupus vasculitis
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Malignant hypertension
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Orthostatic hypotension
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Peripheral ischaemia
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Subgaleal haematoma
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Any event
|
3.0%
8/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Any event
|
2.6%
7/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Angina pectoris
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Coronary artery disease
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Mitral valve disease
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Palpitations
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Any event
|
2.6%
7/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Depression
|
1.1%
3/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Dysthymic disorder
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Mental status changes
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Suicidal ideation
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Suicide attempt
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Any event
|
2.6%
7/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Lupus nephritis
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Renal failure acute
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Any event
|
1.9%
5/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Any event
|
1.9%
5/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.5%
4/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Any event
|
1.5%
4/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Cystocele
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Immune system disorders
Any event
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Immune system disorders
Drug hypersensitivity
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Any event
|
0.75%
2/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Congenital, familial and genetic disorders
Any event
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Congenital, familial and genetic disorders
Spinocerebellar ataxia
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Endocrine disorders
Any event
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Endocrine disorders
Thyroid mass
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Eye disorders
Any event
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Eye disorders
Vision blurred
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Any event
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Influenza A virus test positive
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Influenza B virus test positive
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Any event
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Renal failure
|
0.37%
1/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
Other adverse events
| Measure |
Belimumab 10 mg/kg IV
n=268 participants at risk
Belimumab 10 mg/kg IV every 28 days
|
|---|---|
|
Infections and infestations
Any event
|
90.7%
243/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
28.7%
77/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
28.4%
76/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection bacterial
|
25.7%
69/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Sinusitis
|
23.1%
62/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
22.0%
59/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis viral
|
20.9%
56/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
19.4%
52/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
15.7%
42/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
14.2%
38/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Bronchitis bacterial
|
13.4%
36/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
13.4%
36/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Bronchitis
|
13.1%
35/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Herpes zoster
|
9.0%
24/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Cellulitis
|
7.8%
21/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
7.5%
20/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Oral herpes
|
7.1%
19/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Oral candidiasis
|
6.3%
17/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Tooth abscess
|
5.6%
15/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Any event
|
81.0%
217/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
39.6%
106/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.5%
63/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.5%
55/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
SLE arthritis
|
16.0%
43/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
15.3%
41/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
13.4%
36/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.1%
35/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
11.6%
31/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
10.1%
27/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.7%
26/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.3%
25/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
9.0%
24/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.2%
22/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
5.2%
14/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Any event
|
71.3%
191/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
32.1%
86/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.6%
58/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
16.8%
45/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
14.6%
39/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.7%
34/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
9.3%
25/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dental caries
|
7.8%
21/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Mouth ulceration
|
7.8%
21/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.5%
20/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
18/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Any event
|
60.8%
163/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.6%
39/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.6%
23/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
8.2%
22/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
20/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.0%
16/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.0%
16/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
5.6%
15/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Any event
|
60.4%
162/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
31.3%
84/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
10.8%
29/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Migraine
|
9.3%
25/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Hypoaesthesia
|
6.7%
18/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Paraesthesia
|
6.0%
16/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Any event
|
57.8%
155/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
16.4%
44/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
10.1%
27/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
9.3%
25/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
9.0%
24/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
7.1%
19/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.2%
14/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
5.2%
14/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Any event
|
57.5%
154/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.0%
51/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.6%
31/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
10.4%
28/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.3%
17/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.3%
17/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.0%
16/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
6.0%
16/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Any event
|
56.3%
151/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Fatigue
|
22.4%
60/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
11.6%
31/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Peripheral swelling
|
11.6%
31/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Oedema peripheral
|
11.2%
30/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
11.2%
30/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Pain
|
6.7%
18/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Any event
|
39.9%
107/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
21.3%
57/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
15.7%
42/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Depression
|
11.2%
30/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Any event
|
33.2%
89/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
12.7%
34/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.3%
17/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Any event
|
32.1%
86/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Weight increased
|
9.3%
25/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Any event
|
31.7%
85/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
16.4%
44/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Eye disorders
Any event
|
29.5%
79/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Eye disorders
Cataract
|
6.7%
18/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Any event
|
20.9%
56/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Palpitations
|
7.5%
20/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Immune system disorders
Any event
|
19.8%
53/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Immune system disorders
Seasonal allergy
|
10.8%
29/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Immune system disorders
Drug hypersensitivity
|
6.3%
17/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Any event
|
13.8%
37/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
6.0%
16/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Sinusitis bacterial
|
20.9%
56/268 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).
SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER