Trial Outcomes & Findings for A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02 (NCT NCT00583362)
NCT ID: NCT00583362
Last Updated: 2019-07-23
Results Overview
An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example \[eg\], increase in frequency or severity) of pre-existing conditions. An SAE is defined as an AE resulting in any of the following outcomes: death, is life threatening (that is, an immediate threat to life), inpatient hospitalization, prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, and is medically important.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
298 participants
Primary outcome timeframe
Approximately up to 13 years
Results posted on
2019-07-23
Participant Flow
Participants who completed the parent study LBSL02 (NCT00071487) through the 24-week extension period, who received belimumab 1 milligram (mg)/kilogram (kg), 4 mg/kg, 10 mg/kg or placebo in the parent study and achieved a satisfactory response were enrolled in the study.
Participant milestones
| Measure |
Belimumab 10 mg/kg IV
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Overall Study
STARTED
|
298
|
|
Overall Study
COMPLETED
|
96
|
|
Overall Study
NOT COMPLETED
|
202
|
Reasons for withdrawal
| Measure |
Belimumab 10 mg/kg IV
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Overall Study
Adverse Event
|
44
|
|
Overall Study
Lack of Efficacy
|
22
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Non-compliance with study drug
|
28
|
|
Overall Study
Pregnancy
|
7
|
|
Overall Study
Miscommunication of visit window
|
5
|
|
Overall Study
Current site closed
|
7
|
|
Overall Study
Subject not dosed in LBSL99
|
1
|
|
Overall Study
Subject moved out of the country/state
|
2
|
|
Overall Study
Missed visits due to staff changes
|
1
|
|
Overall Study
Misunderstanding of protocol
|
1
|
|
Overall Study
Behavioral problems and non-compliance
|
1
|
|
Overall Study
Sponsor request due to missed doses
|
1
|
|
Overall Study
Physician Decision
|
19
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Withdrawal by Subject
|
57
|
Baseline Characteristics
A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02
Baseline characteristics by cohort
| Measure |
Belimumab 10 mg/kg IV
n=296 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Age, Continuous
|
43 Years
STANDARD_DEVIATION 11.58 • n=93 Participants
|
|
Sex: Female, Male
Female
|
276 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
6 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
68 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
215 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 13 yearsPopulation: MITT Population. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.
An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example \[eg\], increase in frequency or severity) of pre-existing conditions. An SAE is defined as an AE resulting in any of the following outcomes: death, is life threatening (that is, an immediate threat to life), inpatient hospitalization, prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, and is medically important.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=296 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care 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=296
|
294 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 0-1, n=296
|
291 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 1-2, n=294
|
283 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 2-3, n=276
|
260 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 3-4, n=250
|
239 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 4-5, n=223
|
203 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 5-6, n=209
|
190 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 6-7, n=192
|
182 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 7-8, n=178
|
162 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 8-9, n=169
|
157 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 9-10, n=152
|
137 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 10-11, n=131
|
105 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
AE, Year 11 plus, n=88
|
45 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Any time post baseline, n=296
|
182 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 0-1, n=296
|
41 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 1-2, n=294
|
43 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 2-3, n=276
|
50 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 3-4, n=250
|
30 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 4-5, n=223
|
40 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 5-6, n=209
|
33 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 6-7, n=192
|
35 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 7-8, n=178
|
34 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 8-9, n=169
|
28 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 9-10, n=152
|
25 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 10-11, n=131
|
14 Participants
|
|
Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAE, Year 11 plus, n=88
|
7 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 13 yearsPopulation: 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 treatmentemergent AEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, 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 divided by participant years. Participant years were calculated as sum across all participants (\[last visit of interval day minus first visit of interval day plus 1\] divided by 365).
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=296 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Infections and infestations
|
285 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Musculoskeletal and connective tissue disorders
|
276 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Gastrointestinal disorders
|
257 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Skin and subcutaneous tissue disorders
|
256 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
General disorders, administration site conditions
|
247 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Nervous system disorders
|
244 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Respiratory, thoracic and mediastinal disorders
|
241 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Investigations
|
227 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Injury, poisoning and procedural complications
|
221 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Psychiatric disorders
|
180 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Metabolism and nutrition disorders
|
144 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Vascular disorders
|
134 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Eye disorders
|
133 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Blood and lymphatic system disorders
|
127 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Reproductive system and breast disorders
|
114 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Renal and urinary disorders
|
109 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Immune system disorders
|
101 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Neoplasms benign, malignant and unspecified
|
100 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Cardiac disorders
|
86 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Ear and labyrinth disorders
|
69 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Endocrine disorders
|
40 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Hepatobiliary disorders
|
27 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Social circumstances
|
15 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Congenital, familial and genetic disorders
|
7 Events per 100 participant years
|
|
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Pregnancy, puerperium and perinatal conditions
|
5 Events per 100 participant years
|
PRIMARY outcome
Timeframe: Approximately up to 13 yearsPopulation: MITT population
SAE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatmentemergent SAEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pretreatment 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 divided by participant years. Participant years were calculated as sum across all participants (\[last visit of interval day minus first visit of interval day plus 1\] divided by 365).
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=296 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
SAE Rates by System Organ Class (SOC) During the Study
Infections and infestations
|
69 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Musculoskeletal and connective tissue disorders
|
44 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Gastrointestinal disorders
|
38 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Nervous system disorders
|
35 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
General disorders, administration site conditions
|
31 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Injury, poisoning and procedural complications
|
29 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Respiratory, thoracic and mediastinal disorders
|
25 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Cardiac disorders
|
23 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Neoplasms benign, malignant and unspecified
|
23 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Renal and urinary disorders
|
20 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Vascular disorders
|
19 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Reproductive system and breast disorders
|
18 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Metabolism and nutrition disorders
|
14 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Hepatobiliary disorders
|
10 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Blood and lymphatic system disorders
|
8 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Skin and subcutaneous tissue disorders
|
8 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Investigations
|
7 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Psychiatric disorders
|
6 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Immune system disorders
|
2 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Pregnancy, puerperium and perinatal conditions
|
2 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Congenital, familial and genetic disorders
|
1 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Eye disorders
|
1 Events per 100 participant years
|
|
SAE Rates by System Organ Class (SOC) During the Study
Social circumstances
|
1 Events per 100 participant years
|
PRIMARY outcome
Timeframe: Baseline and approximately up to 13 yearsPopulation: MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Hematology parameters were assessed at Baseline, Week 8, 16, 24, 40, and 48 during Year 1 to 8; Week 8, 16, 24, and 40 during Year 9; Week 24 and 40 during Year 10; Week 48 during Year 11; Week 32 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Extension 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.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=296 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care 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
APTT, Year 1, Week 8, n=274
|
0.3 Seconds
Standard Deviation 12.60
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 1, Week 16, n=276
|
-1.3 Seconds
Standard Deviation 7.46
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 1, Week 24, n=222
|
-1.6 Seconds
Standard Deviation 13.61
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 1, Week 32, n=221
|
-1.9 Seconds
Standard Deviation 7.24
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 1, Week 40, n=219
|
-1.6 Seconds
Standard Deviation 7.00
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 1, Week 48, n=218
|
-1.0 Seconds
Standard Deviation 7.29
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 2, Week 8, n=220
|
-0.3 Seconds
Standard Deviation 6.73
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 2, Week 16, n=214
|
-0.2 Seconds
Standard Deviation 8.79
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 2, Week 24, n=212
|
0.6 Seconds
Standard Deviation 13.81
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 2, Week 32, n=35
|
1.5 Seconds
Standard Deviation 9.20
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 2, Week 40, n=28
|
2.6 Seconds
Standard Deviation 7.53
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 2, Week 48, n=21
|
3.0 Seconds
Standard Deviation 8.69
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 3, Week 8, n=25
|
2.4 Seconds
Standard Deviation 10.70
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 3, Week 16, n=23
|
2.3 Seconds
Standard Deviation 7.77
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 3, Week 24, n=23
|
1.7 Seconds
Standard Deviation 6.30
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 3, Week 32, n=22
|
5.4 Seconds
Standard Deviation 10.01
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 3, Week 40, n=18
|
2.1 Seconds
Standard Deviation 9.62
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 3, Week 48, n=18
|
3.9 Seconds
Standard Deviation 17.23
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 4, Week 8, n=14
|
2.9 Seconds
Standard Deviation 11.42
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 4, Week 16, n=16
|
3.1 Seconds
Standard Deviation 8.97
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 4, Week 24, n=10
|
1.1 Seconds
Standard Deviation 10.29
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 4, Week 32, n=18
|
2.1 Seconds
Standard Deviation 11.37
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 4, Week 40, n=13
|
-2.1 Seconds
Standard Deviation 10.02
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 4, Week 48, n=11
|
2.2 Seconds
Standard Deviation 11.83
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 5, Week 8, n=4
|
3.0 Seconds
Standard Deviation 14.76
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 5, Week 16, n=11
|
1.3 Seconds
Standard Deviation 5.62
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 5, Week 24, n=3
|
13.0 Seconds
Standard Deviation 11.53
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 5, Week 32, n=12
|
3.1 Seconds
Standard Deviation 6.64
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 5, Week 40, n=10
|
-0.5 Seconds
Standard Deviation 8.03
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 5, Week 48, n=3
|
12.3 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 6, Week 8, n=3
|
-2.3 Seconds
Standard Deviation 19.50
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 6, Week 16, n=3
|
9.0 Seconds
Standard Deviation 12.12
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 6, Week 24, n=3
|
14.0 Seconds
Standard Deviation 16.52
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 6, Week 32, n=2
|
6.5 Seconds
Standard Deviation 17.68
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 6, Week 40, n=8
|
9.9 Seconds
Standard Deviation 9.11
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 6, Week 48, n=4
|
18.3 Seconds
Standard Deviation 4.99
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 7, Week 8, n=1
|
27.0 Seconds
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 7, Week 16, n=2
|
24.5 Seconds
Standard Deviation 14.85
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 7, Week 24, n=2
|
19.5 Seconds
Standard Deviation 6.36
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 7, Week 32, n=1
|
7.0 Seconds
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 7, Week 40, n=2
|
16.5 Seconds
Standard Deviation 16.26
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 7, Week 48, n=2
|
18.5 Seconds
Standard Deviation 2.12
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 8, Week 8, n=3
|
11.7 Seconds
Standard Deviation 18.04
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 8, Week 16, n=3
|
15.7 Seconds
Standard Deviation 10.07
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 8, Week 24, n=3
|
21.3 Seconds
Standard Deviation 22.50
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 8, Week 32, n=3
|
8.7 Seconds
Standard Deviation 14.36
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 8, Week 40, n=2
|
25.0 Seconds
Standard Deviation 5.66
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 8, Week 48, n=3
|
13.3 Seconds
Standard Deviation 15.01
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 9, Week 8, n=3
|
10.3 Seconds
Standard Deviation 9.07
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 9, Week 16, n=3
|
11.0 Seconds
Standard Deviation 9.85
|
|
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
|
24.0 Seconds
Standard Deviation 25.46
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 9, Week 32, n=4
|
-11.0 Seconds
Standard Deviation 21.91
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 9, Week 40, n=1
|
20.0 Seconds
Standard Deviation NA
No value as only one participant was analyzed
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 10, Week 24, n=1
|
10.0 Seconds
Standard Deviation NA
No value as only one participant was analyzed
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 10, Week 40, n=1
|
-9 Seconds
Standard Deviation NA
No value as only one participant was analyzed
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 11, Week 48, n=1
|
-27.0 Seconds
Standard Deviation NA
No value as only one participant was analyzed
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Year 13, Week 32, n=1
|
26 Seconds
Standard Deviation NA
No value as only one participant was analyzed
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, Exit, n=10
|
2.3 Seconds
Standard Deviation 9.66
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, 8-Week Follow-up, n=6
|
3.8 Seconds
Standard Deviation 6.24
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
APTT, 24-Week Follow-up, n=3
|
-12.3 Seconds
Standard Deviation 16.56
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 1, Week 8, n=278
|
-0.67 Seconds
Standard Deviation 12.222
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 1, Week 16, n=276
|
-0.98 Seconds
Standard Deviation 12.134
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 1, Week 24, n=222
|
-1.00 Seconds
Standard Deviation 13.859
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 1, Week 32, n=223
|
-0.89 Seconds
Standard Deviation 13.887
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 1, Week 40, n=221
|
-0.67 Seconds
Standard Deviation 14.262
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 1, Week 48, n=219
|
-0.95 Seconds
Standard Deviation 13.496
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 2, Week 8, n=221
|
-0.87 Seconds
Standard Deviation 13.364
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 2, Week 16, n=215
|
-0.84 Seconds
Standard Deviation 13.682
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 2, Week 24, n=214
|
-0.66 Seconds
Standard Deviation 14.156
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 2, Week 32, n=35
|
0.85 Seconds
Standard Deviation 6.887
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 2, Week 40, n=28
|
3.28 Seconds
Standard Deviation 11.046
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 2, Week 48, n=22
|
1.75 Seconds
Standard Deviation 8.747
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 3, Week 8, n=25
|
1.75 Seconds
Standard Deviation 12.409
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 3, Week 16, n=23
|
0.39 Seconds
Standard Deviation 5.469
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 3, Week 24, n=23
|
0.98 Seconds
Standard Deviation 3.120
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 3, Week 32, n=22
|
4.29 Seconds
Standard Deviation 10.640
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 3, Week 40, n=18
|
2.02 Seconds
Standard Deviation 8.833
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 3, Week 48, n=18
|
3.23 Seconds
Standard Deviation 15.863
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 4, Week 8, n=14
|
4.14 Seconds
Standard Deviation 9.948
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 4, Week 16, n=16
|
0.69 Seconds
Standard Deviation 8.188
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 4, Week 24, n=10
|
2.10 Seconds
Standard Deviation 8.506
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 4, Week 32, n=18
|
1.87 Seconds
Standard Deviation 11.251
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 4, Week 40, n=13
|
-2.70 Seconds
Standard Deviation 6.698
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 4, Week 48, n=11
|
0.60 Seconds
Standard Deviation 9.651
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 5, Week 8, n=4
|
-0.43 Seconds
Standard Deviation 12.189
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 5, Week 16, n=11
|
2.52 Seconds
Standard Deviation 6.118
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 5, Week 24, n=3
|
9.90 Seconds
Standard Deviation 8.347
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 5, Week 32, n=12
|
0.67 Seconds
Standard Deviation 3.731
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 5, Week 40, n=10
|
-0.33 Seconds
Standard Deviation 5.443
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 5, Week 48, n=3
|
13.23 Seconds
Standard Deviation 9.064
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 6, Week 8, n=3
|
-2.93 Seconds
Standard Deviation 7.859
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 6, Week 16, n=3
|
2.10 Seconds
Standard Deviation 5.336
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 6, Week 24, n=3
|
7.60 Seconds
Standard Deviation 11.623
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 6, Week 32, n=2
|
4.55 Seconds
Standard Deviation 21.425
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 6, Week 40, n=8
|
2.30 Seconds
Standard Deviation 5.865
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 6, Week 48, n=4
|
6.18 Seconds
Standard Deviation 10.637
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 7, Week 8, n=1
|
19.90 Seconds
Standard Deviation NA
No value as only one participant was analyzed
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 7, Week 16, n=2
|
18.20 Seconds
Standard Deviation 14.425
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 7, Week 24, n=2
|
7.35 Seconds
Standard Deviation 0.636
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 7, Week 32, n=1
|
4.00 Seconds
Standard Deviation NA
No value as only one participant was analyzed
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 7, Week 40, n=2
|
11.15 Seconds
Standard Deviation 19.587
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 7, Week 48, n=2
|
11.50 Seconds
Standard Deviation 4.808
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 8, Week 8, n=3
|
12.47 Seconds
Standard Deviation 15.546
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 8, Week 16, n=3
|
7.57 Seconds
Standard Deviation 6.799
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 8, Week 24, n=3
|
12.87 Seconds
Standard Deviation 13.787
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 8, Week 32, n=3
|
5.63 Seconds
Standard Deviation 9.850
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 8, Week 40, n=2
|
26.60 Seconds
Standard Deviation 13.435
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 8, Week 48, n=3
|
11.07 Seconds
Standard Deviation 9.845
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 9, Week 8, n=3
|
8.23 Seconds
Standard Deviation 7.976
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 9, Week 16, n=3
|
4.60 Seconds
Standard Deviation 6.773
|
|
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
|
25.75 Seconds
Standard Deviation 36.416
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 9, Week 32, n=4
|
-10.08 Seconds
Standard Deviation 8.139
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 9, Week 40, n=1
|
21.40 Seconds
Standard Deviation NA
No value as only one participant was analyzed
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 10, Week 24, n=1
|
1.30 Seconds
Standard Deviation NA
No value as only one participant was analyzed
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 10, Week 40, n=1
|
-8.00 Seconds
Standard Deviation NA
No value as only one participant was analyzed
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 11, Week 48, n=1
|
-22.80 Seconds
Standard Deviation NA
No value as only one participant was analyzed
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Year 13, Week 32, n=1
|
14.80 Seconds
Standard Deviation NA
No value as only one participant was analyzed
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, Exit, n=10
|
0.64 Seconds
Standard Deviation 5.559
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, 8-Week Follow-up, n=6
|
-0.95 Seconds
Standard Deviation 4.561
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
PT, 24-Week Follow-up, n=3
|
-10.23 Seconds
Standard Deviation 11.657
|
PRIMARY outcome
Timeframe: Baseline and approximately up to 13 yearsPopulation: MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils segmented and platelets is summarized. The Baseline is defined as the Extension 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.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=296 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 6, Week 40, n=183
|
0.075 10^9 per liter
Standard Deviation 0.5984
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 6, Week 48, n=188
|
0.043 10^9 per liter
Standard Deviation 0.5839
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 7, Week 8, n=180
|
0.110 10^9 per liter
Standard Deviation 0.6114
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 7, Week 16, n=181
|
0.077 10^9 per liter
Standard Deviation 0.6114
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 7, Week 24, n=176
|
0.091 10^9 per liter
Standard Deviation 0.5944
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 7, Week 32, n=179
|
0.104 10^9 per liter
Standard Deviation 0.5944
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 7, Week 40, n=177
|
0.075 10^9 per liter
Standard Deviation 0.5385
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 7, Week 48, n=173
|
0.060 10^9 per liter
Standard Deviation 0.6039
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 8, Week 8, n=172
|
0.036 10^9 per liter
Standard Deviation 0.5942
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 8, Week 16, n=173
|
-0.005 10^9 per liter
Standard Deviation 0.5480
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 8, Week 24, n=170
|
0.030 10^9 per liter
Standard Deviation 0.6126
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 8, Week 32, n=169
|
-0.020 10^9 per liter
Standard Deviation 0.5269
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 8, Week 40, n=162
|
0.065 10^9 per liter
Standard Deviation 0.6260
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 8, Week 48, n=161
|
0.087 10^9 per liter
Standard Deviation 0.7204
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 9, Week 8, n=164
|
0.090 10^9 per liter
Standard Deviation 0.6612
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 9, Week 16, n=161
|
0.022 10^9 per liter
Standard Deviation 0.5664
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 9, Week 24, n=163
|
0.062 10^9 per liter
Standard Deviation 0.5704
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 9, Week 32, n=159
|
0.017 10^9 per liter
Standard Deviation 0.5326
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 9, Week 40, n=156
|
0.069 10^9 per liter
Standard Deviation 0.6410
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 9, Week 48, n=151
|
0.064 10^9 per liter
Standard Deviation 0.5979
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 10, Week 8, n=149
|
0.046 10^9 per liter
Standard Deviation 0.5547
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 10, Week 16, n=145
|
0.089 10^9 per liter
Standard Deviation 0.6336
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 10, Week 24, n=147
|
0.033 10^9 per liter
Standard Deviation 0.5811
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 10, Week 32, n=142
|
0.076 10^9 per liter
Standard Deviation 0.5914
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 10, Week 40, n=137
|
0.071 10^9 per liter
Standard Deviation 0.5621
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 10, Week 48, n=137
|
0.073 10^9 per liter
Standard Deviation 0.5807
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 11, Week 8, n=137
|
0.112 10^9 per liter
Standard Deviation 0.5764
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 11, Week 16, n=130
|
0.112 10^9 per liter
Standard Deviation 0.6926
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 11, Week 24, n=130
|
0.129 10^9 per liter
Standard Deviation 0.7026
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 11, Week 32, n=128
|
0.139 10^9 per liter
Standard Deviation 0.6249
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 11, Week 40, n=122
|
0.143 10^9 per liter
Standard Deviation 0.6927
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 11, Week 48, n=106
|
0.133 10^9 per liter
Standard Deviation 0.5942
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 12, Week 8, n=109
|
0.145 10^9 per liter
Standard Deviation 0.5976
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 12, Week 16, n=97
|
0.179 10^9 per liter
Standard Deviation 0.5839
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 12, Week 16, n=97
|
-0.032 10^9 per liter
Standard Deviation 2.6750
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 12, Week 24, n=86
|
0.150 10^9 per liter
Standard Deviation 0.5857
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 12, Week 32, n=88
|
0.135 10^9 per liter
Standard Deviation 0.6319
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 12, Week 40, n=83
|
0.150 10^9 per liter
Standard Deviation 0.6512
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 12, Week 48, n=72
|
0.106 10^9 per liter
Standard Deviation 0.5855
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 13, Week 8, n=53
|
0.133 10^9 per liter
Standard Deviation 0.6269
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 13, Week 16, n=42
|
0.078 10^9 per liter
Standard Deviation 0.6783
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 13, Week 24, n=20
|
0.131 10^9 per liter
Standard Deviation 0.6760
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 13, Week 32, n=7
|
0.293 10^9 per liter
Standard Deviation 0.8019
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 13, Week 40, n=1
|
0.160 10^9 per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Exit, n=241
|
0.088 10^9 per liter
Standard Deviation 0.6208
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, 8-Week Follow-up, n=219
|
0.119 10^9 per liter
Standard Deviation 0.6554
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, 24-Week Follow-up, n=198
|
0.054 10^9 per liter
Standard Deviation 0.6847
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 1, Week 8, n=287
|
0.014 10^9 per liter
Standard Deviation 0.1795
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 1, Week 16, n=288
|
0.018 10^9 per liter
Standard Deviation 0.1903
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 1, Week 24, n=293
|
0.007 10^9 per liter
Standard Deviation 0.1834
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 1, Week 32, n=290
|
0.016 10^9 per liter
Standard Deviation 0.1666
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 1, Week 40, n=287
|
0.020 10^9 per liter
Standard Deviation 0.1750
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 1, Week 48, n=287
|
0.018 10^9 per liter
Standard Deviation 0.1739
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 2, Week 8, n=288
|
0.009 10^9 per liter
Standard Deviation 0.1718
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 2, Week 16, n=279
|
0.016 10^9 per liter
Standard Deviation 0.1783
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 2, Week 24, n=276
|
0.029 10^9 per liter
Standard Deviation 0.1764
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 2, Week 32, n=281
|
0.018 10^9 per liter
Standard Deviation 0.1842
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 2, Week 40, n=262
|
0.014 10^9 per liter
Standard Deviation 0.1848
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 12, Week 24, n=86
|
-0.126 10^9 per liter
Standard Deviation 2.2583
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 2, Week 48, n=260
|
0.030 10^9 per liter
Standard Deviation 0.1594
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 3, Week 8, n=260
|
0.024 10^9 per liter
Standard Deviation 0.1677
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 3, Week 16, n=258
|
0.038 10^9 per liter
Standard Deviation 0.1705
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 3, Week 24, n=242
|
0.034 10^9 per liter
Standard Deviation 0.1632
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 3, Week 32, n=248
|
0.022 10^9 per liter
Standard Deviation 0.1776
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 3, Week 40, n=242
|
0.044 10^9 per liter
Standard Deviation 0.1650
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 3, Week 48, n=240
|
0.039 10^9 per liter
Standard Deviation 0.1855
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 4, Week 8, n=234
|
0.035 10^9 per liter
Standard Deviation 0.1687
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 4, Week 16, n=238
|
0.039 10^9 per liter
Standard Deviation 0.1665
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 4, Week 24, n=227
|
0.032 10^9 per liter
Standard Deviation 0.1667
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 4, Week 32, n=229
|
0.027 10^9 per liter
Standard Deviation 0.1566
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 4, Week 40, n=216
|
0.035 10^9 per liter
Standard Deviation 0.1688
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 4, Week 48, n=220
|
0.015 10^9 per liter
Standard Deviation 0.1771
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 12, Week 32, n=88
|
-0.081 10^9 per liter
Standard Deviation 2.5744
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 5, Week 8, n=215
|
0.018 10^9 per liter
Standard Deviation 0.1824
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 5, Week 16, n=214
|
0.036 10^9 per liter
Standard Deviation 0.1527
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 5, Week 24, n=207
|
0.041 10^9 per liter
Standard Deviation 0.1632
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 5, Week 32, n=207
|
0.039 10^9 per liter
Standard Deviation 0.1625
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 5, Week 40, n=196
|
0.049 10^9 per liter
Standard Deviation 0.1510
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 5, Week 48, n=209
|
0.050 10^9 per liter
Standard Deviation 0.1628
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 6, Week 8, n=206
|
0.045 10^9 per liter
Standard Deviation 0.1670
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 6, Week 16, n=195
|
0.033 10^9 per liter
Standard Deviation 0.1700
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 6, Week 24, n=192
|
0.030 10^9 per liter
Standard Deviation 0.1556
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 6, Week 32, n=197
|
0.048 10^9 per liter
Standard Deviation 0.1635
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 6, Week 40, n=183
|
0.051 10^9 per liter
Standard Deviation 0.1342
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 6, Week 48, n=188
|
0.038 10^9 per liter
Standard Deviation 0.1665
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 7, Week 8, n=180
|
0.028 10^9 per liter
Standard Deviation 0.1507
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 7, Week 16, n=181
|
0.030 10^9 per liter
Standard Deviation 0.1482
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 7, Week 24, n=176
|
0.033 10^9 per liter
Standard Deviation 0.1583
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 7, Week 32, n=179
|
0.039 10^9 per liter
Standard Deviation 0.1534
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 7, Week 40, n=177
|
0.047 10^9 per liter
Standard Deviation 0.1391
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 7, Week 48, n=173
|
0.055 10^9 per liter
Standard Deviation 0.1508
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 8, Week 8, n=172
|
0.071 10^9 per liter
Standard Deviation 0.1536
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 8, Week 16, n=173
|
0.072 10^9 per liter
Standard Deviation 0.1464
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 8, Week 24, n=170
|
0.075 10^9 per liter
Standard Deviation 0.1545
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 8, Week 32, n=169
|
0.049 10^9 per liter
Standard Deviation 0.1414
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 8, Week 40, n=162
|
0.070 10^9 per liter
Standard Deviation 0.1480
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 8, Week 48, n=161
|
0.072 10^9 per liter
Standard Deviation 0.1744
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 9, Week 8, n=164
|
0.069 10^9 per liter
Standard Deviation 0.1513
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 9, Week 16, n=161
|
0.063 10^9 per liter
Standard Deviation 0.1462
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 9, Week 24, n=163
|
0.077 10^9 per liter
Standard Deviation 0.1603
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 9, Week 32, n=159
|
0.074 10^9 per liter
Standard Deviation 0.1393
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 9, Week 40, n=156
|
0.075 10^9 per liter
Standard Deviation 0.1440
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 9, Week 48, n=151
|
0.063 10^9 per liter
Standard Deviation 0.1576
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 10, Week 8, n=149
|
0.084 10^9 per liter
Standard Deviation 0.1511
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 10, Week 16, n=145
|
0.083 10^9 per liter
Standard Deviation 0.1439
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 10, Week 24, n=147
|
0.087 10^9 per liter
Standard Deviation 0.1874
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 10, Week 32, n=142
|
0.077 10^9 per liter
Standard Deviation 0.1517
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 10, Week 40, n=137
|
0.064 10^9 per liter
Standard Deviation 0.1522
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 10, Week 48, n=137
|
0.070 10^9 per liter
Standard Deviation 0.1454
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 11, Week 8, n=137
|
0.077 10^9 per liter
Standard Deviation 0.1622
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 11, Week 16, n=130
|
0.077 10^9 per liter
Standard Deviation 0.1484
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 11, Week 24, n=130
|
0.079 10^9 per liter
Standard Deviation 0.1775
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 11, Week 32, n=128
|
0.080 10^9 per liter
Standard Deviation 0.1849
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 11, Week 40, n=122
|
0.075 10^9 per liter
Standard Deviation 0.1435
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 11, Week 48, n=106
|
0.075 10^9 per liter
Standard Deviation 0.1854
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 12, Week 8, n=109
|
0.088 10^9 per liter
Standard Deviation 0.2166
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 12, Week 16, n=97
|
0.104 10^9 per liter
Standard Deviation 0.1829
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 12, Week 24, n=86
|
0.073 10^9 per liter
Standard Deviation 0.1616
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 12, Week 32, n=88
|
0.065 10^9 per liter
Standard Deviation 0.1682
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 12, Week 40, n=83
|
0.078 10^9 per liter
Standard Deviation 0.1734
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 12, Week 48, n=72
|
0.060 10^9 per liter
Standard Deviation 0.1635
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 13, Week 8, n=53
|
0.013 10^9 per liter
Standard Deviation 0.1453
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 13, Week 16, n=42
|
0.061 10^9 per liter
Standard Deviation 0.1882
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 13, Week 24, n=20
|
0.074 10^9 per liter
Standard Deviation 0.1471
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 13, Week 32, n=7
|
0.097 10^9 per liter
Standard Deviation 0.1452
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Year 13, Week 40, n=1
|
0.120 10^9 per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, Exit, n=241
|
0.062 10^9 per liter
Standard Deviation 0.1813
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, 8-Week Follow-up, n=219
|
0.061 10^9 per liter
Standard Deviation 0.2153
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Monocytes, 24-Week Follow-up , n=198
|
0.049 10^9 per liter
Standard Deviation 0.2118
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 1, Week 8, n=287
|
0.003 10^9 per liter
Standard Deviation 1.7881
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 1, Week 16, n=288
|
-0.107 10^9 per liter
Standard Deviation 1.7909
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 1, Week 24, n=293
|
-0.166 10^9 per liter
Standard Deviation 1.9241
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 1, Week 32, n=290
|
-0.129 10^9 per liter
Standard Deviation 2.0814
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 1, Week 40, n=287
|
-0.140 10^9 per liter
Standard Deviation 1.7884
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 1, Week 48, n=287
|
-0.223 10^9 per liter
Standard Deviation 1.7187
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 2, Week 8, n=288
|
-0.301 10^9 per liter
Standard Deviation 2.0434
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 2, Week 16, n=279
|
-0.392 10^9 per liter
Standard Deviation 2.0076
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 2, Week 24, n=276
|
-0.250 10^9 per liter
Standard Deviation 2.2163
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 2, Week 32, n=281
|
-0.129 10^9 per liter
Standard Deviation 2.1622
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 2, Week 40, n=262
|
-0.236 10^9 per liter
Standard Deviation 2.1413
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 2, Week 48, n=260
|
-0.148 10^9 per liter
Standard Deviation 2.1176
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 3, Week 8, n=260
|
-0.333 10^9 per liter
Standard Deviation 2.1308
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 3, Week 16, n=258
|
-0.308 10^9 per liter
Standard Deviation 2.2022
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 3, Week 24, n=242
|
-0.129 10^9 per liter
Standard Deviation 1.9829
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 3, Week 32, n=248
|
-0.211 10^9 per liter
Standard Deviation 2.2333
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 3, Week 40, n=242
|
-0.161 10^9 per liter
Standard Deviation 1.9939
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 3, Week 48, n=240
|
-0.159 10^9 per liter
Standard Deviation 2.1315
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 4, Week 8, n=234
|
-0.119 10^9 per liter
Standard Deviation 2.0635
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 4, Week 16, n=238
|
-0.177 10^9 per liter
Standard Deviation 2.1063
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 4, Week 24, n=227
|
-0.136 10^9 per liter
Standard Deviation 1.9402
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 4, Week 32, n=229
|
-0.123 10^9 per liter
Standard Deviation 2.2231
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 4, Week 40, n=216
|
-0.119 10^9 per liter
Standard Deviation 1.9639
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 4, Week 48, n=220
|
-0.024 10^9 per liter
Standard Deviation 2.2228
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 5, Week 8, n=215
|
-0.169 10^9 per liter
Standard Deviation 2.2107
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 5, Week 16, n=214
|
-0.189 10^9 per liter
Standard Deviation 2.0362
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 5, Week 24, n=207
|
-0.120 10^9 per liter
Standard Deviation 2.0997
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 5, Week 32, n=207
|
-0.088 10^9 per liter
Standard Deviation 2.1895
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 5, Week 40, n=196
|
-0.064 10^9 per liter
Standard Deviation 2.1536
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 5, Week 48, n=209
|
0.014 10^9 per liter
Standard Deviation 2.0473
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 6, Week 8, n=206
|
-0.097 10^9 per liter
Standard Deviation 1.9542
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 6, Week 16, n=195
|
-0.218 10^9 per liter
Standard Deviation 2.2682
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 6, Week 24, n=192
|
-0.226 10^9 per liter
Standard Deviation 2.1749
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 6, Week 32, n=197
|
-0.144 10^9 per liter
Standard Deviation 2.0689
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 6, Week 40, n=183
|
-0.359 10^9 per liter
Standard Deviation 2.2241
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 6, Week 48, n=188
|
-0.306 10^9 per liter
Standard Deviation 2.1609
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 7, Week 8, n=180
|
-0.371 10^9 per liter
Standard Deviation 2.1016
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 7, Week 16, n=181
|
-0.410 10^9 per liter
Standard Deviation 2.0287
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 7, Week 24, n=176
|
-0.363 10^9 per liter
Standard Deviation 2.2018
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 7, Week 32, n=179
|
-0.214 10^9 per liter
Standard Deviation 2.2148
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 7, Week 40, n=177
|
-0.360 10^9 per liter
Standard Deviation 2.2393
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 7, Week 48, n=173
|
-0.423 10^9 per liter
Standard Deviation 2.1389
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 8, Week 8, n=172
|
-0.387 10^9 per liter
Standard Deviation 2.1621
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 8, Week 16, n=173
|
-0.310 10^9 per liter
Standard Deviation 2.1373
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 8, Week 24, n=170
|
-0.152 10^9 per liter
Standard Deviation 2.3134
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 8, Week 32, n=169
|
-0.218 10^9 per liter
Standard Deviation 2.1233
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 8, Week 40, n=162
|
-0.281 10^9 per liter
Standard Deviation 2.2042
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 8, Week 48, n=161
|
-0.407 10^9 per liter
Standard Deviation 2.2558
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 9, Week 8, n=164
|
-0.161 10^9 per liter
Standard Deviation 2.1968
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 9, Week 16, n=161
|
-0.332 10^9 per liter
Standard Deviation 2.0436
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 9, Week 24, n=163
|
-0.240 10^9 per liter
Standard Deviation 2.1439
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 9, Week 32, n=159
|
-0.114 10^9 per liter
Standard Deviation 2.3286
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 9, Week 40, n=156
|
-0.252 10^9 per liter
Standard Deviation 2.2301
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 9, Week 48, n=151
|
-0.268 10^9 per liter
Standard Deviation 2.4153
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 10, Week 8, n=149
|
0.049 10^9 per liter
Standard Deviation 2.4409
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 10, Week 16, n=145
|
0.008 10^9 per liter
Standard Deviation 2.7611
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 10, Week 24, n=147
|
-0.166 10^9 per liter
Standard Deviation 2.2970
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 10, Week 32, n=142
|
-0.299 10^9 per liter
Standard Deviation 2.1597
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 10, Week 40, n=137
|
-0.051 10^9 per liter
Standard Deviation 2.1023
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 10, Week 48, n=137
|
-0.176 10^9 per liter
Standard Deviation 2.0628
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 11, Week 8, n=137
|
-0.077 10^9 per liter
Standard Deviation 2.4456
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 11, Week 16, n=130
|
-0.035 10^9 per liter
Standard Deviation 2.3922
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 11, Week 24, n=130
|
-0.031 10^9 per liter
Standard Deviation 2.2826
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 11, Week 32, n=128
|
0.145 10^9 per liter
Standard Deviation 2.4689
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 11, Week 40, n=122
|
-0.043 10^9 per liter
Standard Deviation 2.2994
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 11, Week 48, n=106
|
-0.004 10^9 per liter
Standard Deviation 2.5913
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 12, Week 8, n=109
|
-0.011 10^9 per liter
Standard Deviation 2.5216
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 12, Week 40, n=83
|
-0.293 10^9 per liter
Standard Deviation 2.2448
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 12, Week 48, n=72
|
-0.126 10^9 per liter
Standard Deviation 2.9212
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 13, Week 8, n=53
|
-0.747 10^9 per liter
Standard Deviation 2.7599
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 13, Week 16, n=42
|
0.169 10^9 per liter
Standard Deviation 2.5731
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 13, Week 24, n=20
|
-0.121 10^9 per liter
Standard Deviation 2.8499
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 13, Week 32, n=7
|
-0.927 10^9 per liter
Standard Deviation 2.9565
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Year 13, Week 40, n=1
|
-0.680 10^9 per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, Exit, n=241
|
0.436 10^9 per liter
Standard Deviation 2.6133
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, 8-Week Follow-up, n=219
|
0.514 10^9 per liter
Standard Deviation 3.6918
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Neutrophils segmented, 24-Week Follow-up, n=198
|
0.369 10^9 per liter
Standard Deviation 2.6988
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 1, Week ,8 n=279
|
3.7 10^9 per liter
Standard Deviation 34.73
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 1, Week 16, n=279
|
4.5 10^9 per liter
Standard Deviation 34.48
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 1, Week 24, n=286
|
7.9 10^9 per liter
Standard Deviation 36.76
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 1, Week 32, n=285
|
10.3 10^9 per liter
Standard Deviation 41.03
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 1, Week 40, n=283
|
13.1 10^9 per liter
Standard Deviation 39.75
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 1, Week 48, n=282
|
13.2 10^9 per liter
Standard Deviation 46.13
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 2, Week 8, n=280
|
18.1 10^9 per liter
Standard Deviation 48.14
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 2, Week 16, n=276
|
15.4 10^9 per liter
Standard Deviation 45.99
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 2, Week 24, n=273
|
16.7 10^9 per liter
Standard Deviation 49.67
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 2, Week 32, n=277
|
24.0 10^9 per liter
Standard Deviation 50.04
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 2, Week 40, n=259
|
21.9 10^9 per liter
Standard Deviation 46.95
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 2, Week 48, n=255
|
21.2 10^9 per liter
Standard Deviation 50.63
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 3, Week 8, n=256
|
22.0 10^9 per liter
Standard Deviation 53.16
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 3, Week 16, n=253
|
22.7 10^9 per liter
Standard Deviation 55.76
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 3, Week 24, n=239
|
18.4 10^9 per liter
Standard Deviation 50.97
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 3, Week 32, n=243
|
14.1 10^9 per liter
Standard Deviation 50.03
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 3, Week 40, n=240
|
14.3 10^9 per liter
Standard Deviation 55.47
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 3, Week 48, n=235
|
12.6 10^9 per liter
Standard Deviation 56.20
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 4, Week 8, n=230
|
11.5 10^9 per liter
Standard Deviation 48.78
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 4, Week 16, n=234
|
11.7 10^9 per liter
Standard Deviation 54.46
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 4, Week 24, n=226
|
11.7 10^9 per liter
Standard Deviation 51.12
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 4, Week 32, n=220
|
9.6 10^9 per liter
Standard Deviation 55.85
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 4, Week 40, n=214
|
5.6 10^9 per liter
Standard Deviation 54.44
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 4, Week 48, n=216
|
6.7 10^9 per liter
Standard Deviation 56.74
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 5, Week 8, n=211
|
4.6 10^9 per liter
Standard Deviation 62.04
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 5, Week 16, n=212
|
-2.1 10^9 per liter
Standard Deviation 54.06
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 5, Week 24, n=206
|
-3.0 10^9 per liter
Standard Deviation 52.05
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 5, Week 32, n=203
|
-4.8 10^9 per liter
Standard Deviation 53.16
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 5, Week 40, n=194
|
-7.7 10^9 per liter
Standard Deviation 51.97
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 5, Week 48, n=206
|
-3.4 10^9 per liter
Standard Deviation 54.93
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 6, Week 8, n=203
|
-10.8 10^9 per liter
Standard Deviation 56.67
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 6, Week 16, n=193
|
-12.7 10^9 per liter
Standard Deviation 56.99
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 6, Week 24, n=190
|
-15.6 10^9 per liter
Standard Deviation 51.76
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 6, Week 32, n=194
|
-12.2 10^9 per liter
Standard Deviation 52.69
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 6, Week 40, n=182
|
-15.8 10^9 per liter
Standard Deviation 56.24
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 6, Week 48, n=186
|
-19.5 10^9 per liter
Standard Deviation 52.68
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 7, Week 8, n=179
|
-17.3 10^9 per liter
Standard Deviation 53.81
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 7, Week 16, n=179
|
-24.2 10^9 per liter
Standard Deviation 49.52
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 7, Week 24, n=175
|
-22.0 10^9 per liter
Standard Deviation 52.19
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 7, Week 32, n=178
|
-19.4 10^9 per liter
Standard Deviation 59.77
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 7, Week 40, n=176
|
-16.6 10^9 per liter
Standard Deviation 63.50
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 7, Week 48, n=171
|
-14.3 10^9 per liter
Standard Deviation 60.69
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 8, Week 8, n=168
|
-11.5 10^9 per liter
Standard Deviation 54.16
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 8, Week 16, n=172
|
-15.0 10^9 per liter
Standard Deviation 58.24
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 8, Week 40, n=161
|
-12.0 10^9 per liter
Standard Deviation 62.73
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 8, Week 24, n=169
|
-11.0 10^9 per liter
Standard Deviation 56.12
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 8, Week 32, n=168
|
-13.9 10^9 per liter
Standard Deviation 55.53
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 8, Week 48, n=161
|
-8.9 10^9 per liter
Standard Deviation 80.44
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 9, Week 8, n=162
|
-8.4 10^9 per liter
Standard Deviation 64.02
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 9, Week 16, n=160
|
-11.7 10^9 per liter
Standard Deviation 68.06
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 9, Week 24, n=162
|
-13.6 10^9 per liter
Standard Deviation 60.20
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 9, Week 32, n=158
|
-16.8 10^9 per liter
Standard Deviation 62.14
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 9, Week 40, n=156
|
-13.4 10^9 per liter
Standard Deviation 63.09
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 9, Week 48, n=150
|
-13.0 10^9 per liter
Standard Deviation 65.20
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 10, Week 8, n=149
|
-10.9 10^9 per liter
Standard Deviation 60.24
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 1, Week 8, n=287
|
0.001 10^9 per liter
Standard Deviation 0.0163
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 1, Week 16, n=288
|
0.000 10^9 per liter
Standard Deviation 0.0181
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 1, Week 24, n=293
|
0.000 10^9 per liter
Standard Deviation 0.0171
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 1, Week 32, n=290
|
0.002 10^9 per liter
Standard Deviation 0.0166
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 1, Week 40, n=287
|
0.001 10^9 per liter
Standard Deviation 0.0159
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 1, Week 48, n=287
|
0.001 10^9 per liter
Standard Deviation 0.0178
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 2, Week 8, n=288
|
0.001 10^9 per liter
Standard Deviation 0.0164
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 2, Week 16, n=279
|
0.002 10^9 per liter
Standard Deviation 0.0172
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 2, Week 24, n=276
|
0.001 10^9 per liter
Standard Deviation 0.0168
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 2, Week 32, n=281
|
0.003 10^9 per liter
Standard Deviation 0.0179
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 2, Week 40, n=262
|
0.002 10^9 per liter
Standard Deviation 0.0162
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 2, Week 48, n=260
|
0.003 10^9 per liter
Standard Deviation 0.0174
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 3, Week 8, n=260
|
0.003 10^9 per liter
Standard Deviation 0.0167
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 3, Week 16, n=258
|
0.004 10^9 per liter
Standard Deviation 0.0177
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 3, Week 24, n=242
|
0.002 10^9 per liter
Standard Deviation 0.0160
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 3, Week 32, n=248
|
0.004 10^9 per liter
Standard Deviation 0.0204
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 3, Week 40, n=242
|
0.004 10^9 per liter
Standard Deviation 0.0178
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 3, Week 48, n=240
|
0.002 10^9 per liter
Standard Deviation 0.0172
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 4, Week 8, n=234
|
0.001 10^9 per liter
Standard Deviation 0.0189
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 4, Week 16, n=238
|
0.003 10^9 per liter
Standard Deviation 0.0183
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 4, Week 24, n=227
|
0.003 10^9 per liter
Standard Deviation 0.0160
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 4, Week 32, n=229
|
0.003 10^9 per liter
Standard Deviation 0.0174
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 4, Week 40, n=216
|
0.004 10^9 per liter
Standard Deviation 0.0174
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 4, Week 48, n=220
|
0.002 10^9 per liter
Standard Deviation 0.0181
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 5, Week 8, n=215
|
0.004 10^9 per liter
Standard Deviation 0.0173
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 5, Week 16, n=214
|
0.003 10^9 per liter
Standard Deviation 0.0182
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 5, Week 24, n=207
|
0.003 10^9 per liter
Standard Deviation 0.0174
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 5, Week 32, n=207
|
0.002 10^9 per liter
Standard Deviation 0.0159
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 5, Week 40, n=196
|
0.003 10^9 per liter
Standard Deviation 0.0184
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 5, Week 48, n=209
|
0.004 10^9 per liter
Standard Deviation 0.0177
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 6, Week 8, n=206
|
0.004 10^9 per liter
Standard Deviation 0.0183
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 6, Week 16, n=195
|
0.004 10^9 per liter
Standard Deviation 0.0203
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 6, Week 24, n=192
|
0.003 10^9 per liter
Standard Deviation 0.0212
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 6, Week 32, n=197
|
0.004 10^9 per liter
Standard Deviation 0.0177
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 6, Week 40, n=183
|
0.003 10^9 per liter
Standard Deviation 0.0157
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 6, Week 48, n=188
|
0.002 10^9 per liter
Standard Deviation 0.0174
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 7, Week 8, n=180
|
0.002 10^9 per liter
Standard Deviation 0.0194
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 7, Week 16, n=181
|
0.001 10^9 per liter
Standard Deviation 0.0186
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 7, Week 24, n=176
|
0.003 10^9 per liter
Standard Deviation 0.0178
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 7, Week 32, n=179
|
0.004 10^9 per liter
Standard Deviation 0.0173
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 7, Week 40, n=177
|
0.004 10^9 per liter
Standard Deviation 0.0172
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 7, Week 48, n=173
|
0.004 10^9 per liter
Standard Deviation 0.0171
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 8, Week 8, n=172
|
0.003 10^9 per liter
Standard Deviation 0.0184
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 8, Week 16, n=173
|
0.005 10^9 per liter
Standard Deviation 0.0167
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 8, Week 24, n=170
|
0.005 10^9 per liter
Standard Deviation 0.0160
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 8, Week 32, n=169
|
0.003 10^9 per liter
Standard Deviation 0.0165
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 8, Week 40, n=162
|
0.005 10^9 per liter
Standard Deviation 0.0177
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 8, Week 48, n=161
|
0.004 10^9 per liter
Standard Deviation 0.0187
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 9, Week 8, n=164
|
0.006 10^9 per liter
Standard Deviation 0.0227
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 9, Week 16, n=161
|
0.005 10^9 per liter
Standard Deviation 0.0194
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 9, Week 24, n=163
|
0.004 10^9 per liter
Standard Deviation 0.0170
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 9, Week 32, n=159
|
0.004 10^9 per liter
Standard Deviation 0.0167
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 9, Week 40, n=156
|
0.004 10^9 per liter
Standard Deviation 0.0180
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 9, Week 48, n=151
|
0.003 10^9 per liter
Standard Deviation 0.0153
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 10, Week 8, n=149
|
0.002 10^9 per liter
Standard Deviation 0.0183
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 10, Week 16, n=145
|
0.006 10^9 per liter
Standard Deviation 0.0205
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 10, Week 24, n=147
|
0.003 10^9 per liter
Standard Deviation 0.0186
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 10, Week 32, n=142
|
0.005 10^9 per liter
Standard Deviation 0.0214
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 10, Week 40, n=137
|
0.004 10^9 per liter
Standard Deviation 0.0192
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 10, Week 48, n=137
|
0.006 10^9 per liter
Standard Deviation 0.0185
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 11, Week 8, n=137
|
0.004 10^9 per liter
Standard Deviation 0.0200
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 11, Week 16, n=130
|
0.004 10^9 per liter
Standard Deviation 0.0188
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 11, Week 24, n=130
|
0.005 10^9 per liter
Standard Deviation 0.0176
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 11, Week 32, n=128
|
0.006 10^9 per liter
Standard Deviation 0.0187
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 11, Week 40, n=122
|
0.006 10^9 per liter
Standard Deviation 0.0232
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 11, Week 48, n=106
|
0.005 10^9 per liter
Standard Deviation 0.0189
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 12, Week 8, n=109
|
0.007 10^9 per liter
Standard Deviation 0.0209
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 12, Week 16, n=97
|
0.004 10^9 per liter
Standard Deviation 0.0197
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 12, Week 24, n=86
|
0.007 10^9 per liter
Standard Deviation 0.0204
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 12, Week 32, n=88
|
0.004 10^9 per liter
Standard Deviation 0.0213
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 12, Week 40, n=83
|
0.007 10^9 per liter
Standard Deviation 0.0201
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 12, Week 48, n=72
|
0.006 10^9 per liter
Standard Deviation 0.0172
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 13, Week 8, n=53
|
0.005 10^9 per liter
Standard Deviation 0.0173
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 13, Week 16, n=42
|
0.006 10^9 per liter
Standard Deviation 0.0178
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 13, Week 24, n=20
|
0.008 10^9 per liter
Standard Deviation 0.0170
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 13, Week 32, n=7
|
0.014 10^9 per liter
Standard Deviation 0.0151
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Year 13, Week 40, n=1
|
0.020 10^9 per liter
Standard Deviation NA
No value as only one participant was analyzed
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, Exit, n=241
|
0.005 10^9 per liter
Standard Deviation 0.0171
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, 8-Week Follow-up, n=219
|
0.006 10^9 per liter
Standard Deviation 0.0205
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Basophils, 24-Week Follow-up, n=198
|
0.006 10^9 per liter
Standard Deviation 0.0213
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 1, Week 8, n=287
|
0.003 10^9 per liter
Standard Deviation 0.0999
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 1, Week 16, n=288
|
0.007 10^9 per liter
Standard Deviation 0.1213
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 1, Week 24, n=293
|
0.008 10^9 per liter
Standard Deviation 0.1222
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 1, Week 32, n=290
|
0.011 10^9 per liter
Standard Deviation 0.1219
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 1, Week 40, n=287
|
0.007 10^9 per liter
Standard Deviation 0.1070
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 1, Week 48, n=287
|
0.006 10^9 per liter
Standard Deviation 0.1130
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 2, Week 8, n=288
|
0.003 10^9 per liter
Standard Deviation 0.1135
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 2, Week 16, n=279
|
0.034 10^9 per liter
Standard Deviation 0.1312
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 2, Week 24, n=276
|
0.023 10^9 per liter
Standard Deviation 0.1375
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 2, Week 32, n=281
|
0.028 10^9 per liter
Standard Deviation 0.1423
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 2, Week 40, n=262
|
0.028 10^9 per liter
Standard Deviation 0.1280
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 2, Week 48, n=260
|
0.042 10^9 per liter
Standard Deviation 0.1635
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 3, Week 8, n=260
|
0.033 10^9 per liter
Standard Deviation 0.1353
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 3, Week 16, n=258
|
0.038 10^9 per liter
Standard Deviation 0.1391
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 3, Week 24, n=242
|
0.038 10^9 per liter
Standard Deviation 0.1610
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 3, Week 32, n=248
|
0.029 10^9 per liter
Standard Deviation 0.1427
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 3, Week 40, n=242
|
0.035 10^9 per liter
Standard Deviation 0.1539
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 3, Week 48, n=240
|
0.033 10^9 per liter
Standard Deviation 0.1369
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 4, Week 8, n=234
|
0.035 10^9 per liter
Standard Deviation 0.1331
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 4, Week 16, n=238
|
0.034 10^9 per liter
Standard Deviation 0.1273
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 4, Week 24, n=227
|
0.033 10^9 per liter
Standard Deviation 0.1384
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 4, Week 32, n=229
|
0.039 10^9 per liter
Standard Deviation 0.1381
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 4, Week 40, n=216
|
0.038 10^9 per liter
Standard Deviation 0.1284
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 4, Week 48, n=220
|
0.030 10^9 per liter
Standard Deviation 0.1261
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 5, Week 8, n=215
|
0.035 10^9 per liter
Standard Deviation 0.1242
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 5, Week 16, n=214
|
0.019 10^9 per liter
Standard Deviation 0.1294
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 5, Week 24, n=207
|
0.023 10^9 per liter
Standard Deviation 0.1078
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 5, Week 32, n=207
|
0.027 10^9 per liter
Standard Deviation 0.1201
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 5, Week 40, n=196
|
0.019 10^9 per liter
Standard Deviation 0.1224
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 5, Week 48, n=209
|
0.022 10^9 per liter
Standard Deviation 0.1224
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 6, Week 8, n=206
|
0.020 10^9 per liter
Standard Deviation 0.1288
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 6, Week 16, n=195
|
0.021 10^9 per liter
Standard Deviation 0.1103
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 6, Week 24, n=192
|
0.034 10^9 per liter
Standard Deviation 0.1335
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 6, Week 32, n=197
|
0.026 10^9 per liter
Standard Deviation 0.1171
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 6, Week 40, n=183
|
0.044 10^9 per liter
Standard Deviation 0.1580
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 6, Week 48, n=188
|
0.026 10^9 per liter
Standard Deviation 0.1299
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 7, Week 8, n=180
|
0.021 10^9 per liter
Standard Deviation 0.1317
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 7, Week 16, n=181
|
0.015 10^9 per liter
Standard Deviation 0.1170
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 7, Week 24, n=176
|
0.014 10^9 per liter
Standard Deviation 0.1239
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 7, Week 32, n=179
|
0.010 10^9 per liter
Standard Deviation 0.1149
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 7, Week 40, n=177
|
0.009 10^9 per liter
Standard Deviation 0.1167
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 7, Week 48, n=173
|
-0.008 10^9 per liter
Standard Deviation 0.1176
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 8, Week 8, n=172
|
-0.003 10^9 per liter
Standard Deviation 0.1389
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 8, Week 16, n=173
|
-0.009 10^9 per liter
Standard Deviation 0.1234
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 8, Week 24, n=170
|
-0.007 10^9 per liter
Standard Deviation 0.1309
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 8, Week 32, n=169
|
-0.023 10^9 per liter
Standard Deviation 0.1136
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 8, Week 40, n=162
|
-0.009 10^9 per liter
Standard Deviation 0.1263
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 8, Week 48, n=161
|
-0.011 10^9 per liter
Standard Deviation 0.1341
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 9, Week 8, n=164
|
-0.004 10^9 per liter
Standard Deviation 0.1373
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 9, Week 16, n=161
|
-0.020 10^9 per liter
Standard Deviation 0.1204
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 9, Week 24, n=163
|
-0.020 10^9 per liter
Standard Deviation 0.1134
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 9, Week 32, n=159
|
-0.012 10^9 per liter
Standard Deviation 0.1154
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 9, Week 40, n=156
|
-0.029 10^9 per liter
Standard Deviation 0.1200
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 9, Week 48, n=151
|
-0.018 10^9 per liter
Standard Deviation 0.1307
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 10, Week 8, n=149
|
-0.020 10^9 per liter
Standard Deviation 0.1343
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 10, Week 16, n=145
|
-0.010 10^9 per liter
Standard Deviation 0.1438
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 10, Week 24, n=147
|
-0.019 10^9 per liter
Standard Deviation 0.1237
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 10, Week 32, n=142
|
-0.002 10^9 per liter
Standard Deviation 0.1332
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 10, Week 40, n=137
|
-0.021 10^9 per liter
Standard Deviation 0.1184
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 10, Week 48, n=137
|
-0.021 10^9 per liter
Standard Deviation 0.1274
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 11, Week 8, n=137
|
-0.018 10^9 per liter
Standard Deviation 0.1167
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 11, Week 16, n=130
|
-0.004 10^9 per liter
Standard Deviation 0.1336
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 11, Week 24, n=130
|
0.004 10^9 per liter
Standard Deviation 0.1445
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 11, Week 32, n=128
|
0.003 10^9 per liter
Standard Deviation 0.1360
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 11, Week 40, n=122
|
-0.013 10^9 per liter
Standard Deviation 0.1298
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 11, Week 48, n=106
|
-0.021 10^9 per liter
Standard Deviation 0.1435
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 12, Week 8, n=109
|
-0.021 10^9 per liter
Standard Deviation 0.1242
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 12, Week 16, n=97
|
-0.020 10^9 per liter
Standard Deviation 0.1349
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 12, Week 24, n=86
|
-0.000 10^9 per liter
Standard Deviation 0.1535
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 12, Week 32, n=88
|
-0.008 10^9 per liter
Standard Deviation 0.1356
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 12, Week 40, n=83
|
-0.020 10^9 per liter
Standard Deviation 0.1242
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 12, Week 48, n=72
|
-0.016 10^9 per liter
Standard Deviation 0.1319
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 13, Week 8, n=53
|
-0.001 10^9 per liter
Standard Deviation 0.1436
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 13, Week 16, n=42
|
-0.009 10^9 per liter
Standard Deviation 0.1244
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 13, Week 24, n=20
|
0.035 10^9 per liter
Standard Deviation 0.1810
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 13, Week 32, n=7
|
0.081 10^9 per liter
Standard Deviation 0.0722
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Year 13, Week 40, n=1
|
0.080 10^9 per liter
Standard Deviation NA
No value as only one participant was analyzed
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, Exit, n=241
|
0.006 10^9 per liter
Standard Deviation 0.1430
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, 8-Week Follow-up, n=219
|
-0.002 10^9 per liter
Standard Deviation 0.1436
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Eosinophils, 24-Week Follow-up, n=198
|
0.013 10^9 per liter
Standard Deviation 0.2255
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 1, Week 8, n=287
|
0.006 10^9 per liter
Standard Deviation 0.4143
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 1, Week 16, n=288
|
-0.046 10^9 per liter
Standard Deviation 0.4612
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 1, Week 24, n=293
|
-0.035 10^9 per liter
Standard Deviation 0.4725
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 1, Week 32, n=290
|
-0.057 10^9 per liter
Standard Deviation 0.4425
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 1, Week 40, n=287
|
-0.074 10^9 per liter
Standard Deviation 0.5084
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 1, Week 48, n=287
|
-0.075 10^9 per liter
Standard Deviation 0.4832
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 2, Week 8, n=288
|
-0.049 10^9 per liter
Standard Deviation 0.4324
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 2, Week 16, n=279
|
-0.025 10^9 per liter
Standard Deviation 0.4774
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 2, Week 24, n=276
|
-0.053 10^9 per liter
Standard Deviation 0.4949
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 2, Week 32, n=281
|
-0.038 10^9 per liter
Standard Deviation 0.5080
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 2, Week 40, n=262
|
-0.025 10^9 per liter
Standard Deviation 0.5046
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 2, Week 48, n=260
|
0.006 10^9 per liter
Standard Deviation 0.4874
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 3, Week 8, n=260
|
-0.037 10^9 per liter
Standard Deviation 0.5202
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 3, Week 16, n=258
|
-0.019 10^9 per liter
Standard Deviation 0.5004
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 3, Week 24, n=242
|
-0.045 10^9 per liter
Standard Deviation 0.5131
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 3, Week 32, n=248
|
-0.008 10^9 per liter
Standard Deviation 0.4702
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 3, Week 40, n=242
|
-0.015 10^9 per liter
Standard Deviation 0.5407
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 3, Week 48, n=240
|
-0.016 10^9 per liter
Standard Deviation 0.5858
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 4, Week 8, n=234
|
-0.041 10^9 per liter
Standard Deviation 0.4933
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 4, Week 16, n=238
|
-0.012 10^9 per liter
Standard Deviation 0.4974
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 4, Week 24, n=227
|
0.034 10^9 per liter
Standard Deviation 0.5406
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 4, Week 32, n=229
|
0.017 10^9 per liter
Standard Deviation 0.5270
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 4, Week 40, n=216
|
0.003 10^9 per liter
Standard Deviation 0.4347
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 4, Week 48, n=220
|
0.017 10^9 per liter
Standard Deviation 0.4826
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 5, Week 8, n=215
|
0.012 10^9 per liter
Standard Deviation 0.4654
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 5, Week 16, n=214
|
0.050 10^9 per liter
Standard Deviation 0.5205
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 5, Week 24, n=207
|
0.052 10^9 per liter
Standard Deviation 0.5355
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 5, Week 32, n=207
|
0.031 10^9 per liter
Standard Deviation 0.5323
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 5, Week 40, n=196
|
0.057 10^9 per liter
Standard Deviation 0.5482
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 5, Week 48, n=209
|
0.031 10^9 per liter
Standard Deviation 0.5125
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 6, Week 8, n=206
|
0.059 10^9 per liter
Standard Deviation 0.5734
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 6, Week 16, n=195
|
0.045 10^9 per liter
Standard Deviation 0.5931
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 6, Week 24, n=192
|
0.087 10^9 per liter
Standard Deviation 0.5757
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Lymphocytes, Year 6, Week 32, n=197
|
0.066 10^9 per liter
Standard Deviation 0.5970
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 10, Week 16, n=144
|
-9.7 10^9 per liter
Standard Deviation 62.61
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 10, Week 24, n=146
|
-9.7 10^9 per liter
Standard Deviation 60.67
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 10, Week 32, n=141
|
-10.6 10^9 per liter
Standard Deviation 62.35
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 10, Week 40, n=136
|
-9.5 10^9 per liter
Standard Deviation 61.80
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 10, Week 48, n=136
|
-11.7 10^9 per liter
Standard Deviation 61.81
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 11, Week 8, n=136
|
-8.4 10^9 per liter
Standard Deviation 69.58
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 11, Week 16, n=129
|
-6.4 10^9 per liter
Standard Deviation 63.81
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 11, Week 24, n=129
|
-6.7 10^9 per liter
Standard Deviation 61.75
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 11, Week 32, n=127
|
-3.0 10^9 per liter
Standard Deviation 65.54
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 11, Week 40, n=121
|
-5.8 10^9 per liter
Standard Deviation 68.01
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 11, Week 48, n=105
|
-7.8 10^9 per liter
Standard Deviation 62.13
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 12, Week 8, n=108
|
-4.1 10^9 per liter
Standard Deviation 73.02
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 12, Week 16, n=96
|
-10.6 10^9 per liter
Standard Deviation 68.02
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 12, Week 24, n=84
|
-11.5 10^9 per liter
Standard Deviation 60.94
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 12, Week 32, n=87
|
-5.7 10^9 per liter
Standard Deviation 70.98
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 12, Week 40, n=82
|
-10.7 10^9 per liter
Standard Deviation 67.51
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 12, Week 48, n=72
|
-8.7 10^9 per liter
Standard Deviation 80.99
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 13, Week 8, n=53
|
-8.6 10^9 per liter
Standard Deviation 70.53
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 13, Week 16, n=41
|
-6.2 10^9 per liter
Standard Deviation 61.57
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 13, Week 24, n=20
|
-7.1 10^9 per liter
Standard Deviation 47.37
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 13, Week 32, n=7
|
-6.7 10^9 per liter
Standard Deviation 51.61
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Year 13, Week 40, n=1
|
-29.0 10^9 per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, Exit, n=236
|
8.4 10^9 per liter
Standard Deviation 77.24
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, 8-Week Follow-up, n=217
|
8.2 10^9 per liter
Standard Deviation 71.32
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Platelets, 24-Week Follow-up, n=194
|
4.0 10^9 per liter
Standard Deviation 67.29
|
PRIMARY outcome
Timeframe: Baseline and approximately up to 13 yearsPopulation: MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Extension 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.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=296 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 1, Week 8, n=287
|
0.01 10^12 per liter
Standard Deviation 0.313
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 1, Week 16, n=288
|
0.04 10^12 per liter
Standard Deviation 0.361
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 1, Week 24, n=293
|
0.05 10^12 per liter
Standard Deviation 0.309
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 1, Week 32, n=291
|
0.07 10^12 per liter
Standard Deviation 0.301
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 1, Week 40, n=287
|
0.10 10^12 per liter
Standard Deviation 0.321
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 1, Week 48, n=287
|
0.11 10^12 per liter
Standard Deviation 0.338
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 2, Week 8, n=288
|
0.07 10^12 per liter
Standard Deviation 0.339
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 2, Week 16, n=280
|
0.09 10^12 per liter
Standard Deviation 0.320
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 2, Week 24, n=278
|
0.12 10^12 per liter
Standard Deviation 0.331
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 2, Week 32, n=281
|
0.15 10^12 per liter
Standard Deviation 0.331
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 2, Week 40, n=262
|
0.17 10^12 per liter
Standard Deviation 0.330
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 2, Week 48, n=260
|
0.19 10^12 per liter
Standard Deviation 0.336
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 3, Week 8, n=260
|
0.18 10^12 per liter
Standard Deviation 0.331
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 3, Week 16, n=258
|
0.19 10^12 per liter
Standard Deviation 0.347
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 3, Week 24, n=242
|
0.17 10^12 per liter
Standard Deviation 0.384
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 3, Week 32, n=248
|
0.16 10^12 per liter
Standard Deviation 0.356
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 3, Week 40, n=243
|
0.17 10^12 per liter
Standard Deviation 0.369
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 3, Week 48, n=240
|
0.15 10^12 per liter
Standard Deviation 0.368
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 4, Week 8, n=235
|
0.15 10^12 per liter
Standard Deviation 0.392
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 4, Week 16, n=238
|
0.15 10^12 per liter
Standard Deviation 0.367
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 4, Week 24, n=227
|
0.12 10^12 per liter
Standard Deviation 0.363
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 4, Week 32, n=229
|
0.14 10^12 per liter
Standard Deviation 0.394
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 4, Week 40, n=216
|
0.14 10^12 per liter
Standard Deviation 0.383
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 4, Week 48, n=220
|
0.14 10^12 per liter
Standard Deviation 0.420
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 5, Week 8, n=215
|
0.13 10^12 per liter
Standard Deviation 0.435
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 5, Week 16, n=214
|
0.15 10^12 per liter
Standard Deviation 0.432
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 5, Week 24, n=207
|
0.13 10^12 per liter
Standard Deviation 0.426
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 5, Week 32, n=207
|
0.12 10^12 per liter
Standard Deviation 0.430
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 5, Week 40, n=196
|
0.15 10^12 per liter
Standard Deviation 0.417
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 5, Week 48, n=209
|
0.15 10^12 per liter
Standard Deviation 0.420
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 6, Week 8, n=206
|
0.13 10^12 per liter
Standard Deviation 0.441
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 6, Week 16, n=195
|
0.10 10^12 per liter
Standard Deviation 0.448
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 6, Week 24, n=192
|
0.13 10^12 per liter
Standard Deviation 0.380
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 6, Week 32, n=197
|
0.14 10^12 per liter
Standard Deviation 0.420
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 6, Week 40, n=184
|
0.15 10^12 per liter
Standard Deviation 0.430
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 6, Week 48, n=188
|
0.13 10^12 per liter
Standard Deviation 0.401
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 7, Week 8, n=180
|
0.12 10^12 per liter
Standard Deviation 0.397
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 7, Week 16, n=181
|
0.09 10^12 per liter
Standard Deviation 0.407
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 7, Week 24, n=176
|
0.11 10^12 per liter
Standard Deviation 0.390
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 7, Week 32, n=179
|
0.14 10^12 per liter
Standard Deviation 0.395
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 7, Week 40, n=177
|
0.09 10^12 per liter
Standard Deviation 0.391
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 7, Week 48, n=173
|
0.09 10^12 per liter
Standard Deviation 0.394
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 8, Week 8, n=172
|
0.09 10^12 per liter
Standard Deviation 0.378
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 8, Week 16, n=173
|
0.08 10^12 per liter
Standard Deviation 0.368
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 8, Week 24, n=170
|
0.10 10^12 per liter
Standard Deviation 0.388
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 8, Week 32, n=169
|
0.11 10^12 per liter
Standard Deviation 0.373
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 8, Week 40, n=162
|
0.10 10^12 per liter
Standard Deviation 0.415
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 8, Week 48, n=161
|
0.12 10^12 per liter
Standard Deviation 0.411
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 9, Week 8, n=164
|
0.11 10^12 per liter
Standard Deviation 0.402
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 9, Week 16, n=161
|
0.09 10^12 per liter
Standard Deviation 0.396
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 9, Week 24, n=163
|
0.08 10^12 per liter
Standard Deviation 0.387
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 9, Week 32, n=160
|
0.11 10^12 per liter
Standard Deviation 0.409
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 9, Week 40, n=156
|
0.09 10^12 per liter
Standard Deviation 0.407
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 9, Week 48, n=151
|
0.11 10^12 per liter
Standard Deviation 0.431
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 10, Week 8, n=150
|
0.16 10^12 per liter
Standard Deviation 0.442
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 10, Week 16, n=145
|
0.17 10^12 per liter
Standard Deviation 0.411
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 10, Week 24, n=147
|
0.21 10^12 per liter
Standard Deviation 0.427
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 10, Week 32, n=142
|
0.18 10^12 per liter
Standard Deviation 0.419
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 10, Week 40, n=137
|
0.20 10^12 per liter
Standard Deviation 0.417
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 10, Week 48, n=137
|
0.19 10^12 per liter
Standard Deviation 0.429
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 11, Week 8, n=137
|
0.20 10^12 per liter
Standard Deviation 0.430
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 11, Week 16, n=130
|
0.24 10^12 per liter
Standard Deviation 0.422
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 11, Week 24, n=130
|
0.25 10^12 per liter
Standard Deviation 0.436
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 11, Week 32, n=128
|
0.27 10^12 per liter
Standard Deviation 0.410
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 11, Week 40, n=122
|
0.27 10^12 per liter
Standard Deviation 0.426
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 11, Week 48, n=106
|
0.25 10^12 per liter
Standard Deviation 0.426
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 12, Week 8, n=109
|
0.29 10^12 per liter
Standard Deviation 0.422
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 12, Week 16, n=97
|
0.28 10^12 per liter
Standard Deviation 0.435
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 12, Week 24, n=86
|
0.33 10^12 per liter
Standard Deviation 0.483
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 12, Week 32, n=88
|
0.26 10^12 per liter
Standard Deviation 0.512
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 12, Week 40, n=83
|
0.31 10^12 per liter
Standard Deviation 0.428
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 12, Week 48, n=72
|
0.32 10^12 per liter
Standard Deviation 0.467
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 13, Week 8, n=53
|
0.35 10^12 per liter
Standard Deviation 0.400
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 13, Week 16, n=42
|
0.34 10^12 per liter
Standard Deviation 0.387
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 13, Week 24, n=20
|
0.30 10^12 per liter
Standard Deviation 0.407
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 13, Week 32, n=7
|
0.20 10^12 per liter
Standard Deviation 0.379
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Year 13, Week 40, n=1
|
0.30 10^12 per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, Exit, n=241
|
0.27 10^12 per liter
Standard Deviation 0.473
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, 8-Week Follow-up, n=220
|
0.28 10^12 per liter
Standard Deviation 0.478
|
|
Change From Baseline in Erythrocytes at the Indicated Time Points
Erythrocytes, 24-Week Follow-up , n=198
|
0.33 10^12 per liter
Standard Deviation 0.539
|
PRIMARY outcome
Timeframe: Baseline and approximately up to 13 yearsPopulation: MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Extension 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.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=296 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 1, Week 8, n=287
|
0.11 Percentage of blood by volume
Standard Deviation 2.908
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 1, Week 16, n=288
|
0.23 Percentage of blood by volume
Standard Deviation 3.109
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 1, Week 24, n=293
|
0.28 Percentage of blood by volume
Standard Deviation 2.917
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 1, Week 32, n=291
|
0.44 Percentage of blood by volume
Standard Deviation 2.973
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 1, Week 40, n=287
|
0.60 Percentage of blood by volume
Standard Deviation 3.199
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 1, Week 48, n=287
|
0.84 Percentage of blood by volume
Standard Deviation 3.431
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 2, Week 8, n=288
|
0.67 Percentage of blood by volume
Standard Deviation 3.415
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 2, Week 16, n=280
|
0.93 Percentage of blood by volume
Standard Deviation 3.332
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 2, Week 24, n=278
|
0.96 Percentage of blood by volume
Standard Deviation 3.435
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 2, Week 32, n=281
|
1.34 Percentage of blood by volume
Standard Deviation 3.496
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 12, Week 24, n=86
|
3.74 Percentage of blood by volume
Standard Deviation 4.867
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 12, Week 32, n=88
|
2.99 Percentage of blood by volume
Standard Deviation 4.826
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 12, Week 40, n=83
|
3.57 Percentage of blood by volume
Standard Deviation 4.377
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 2, Week 40, n=262
|
1.43 Percentage of blood by volume
Standard Deviation 3.476
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 2, Week 48, n=260
|
1.65 Percentage of blood by volume
Standard Deviation 3.444
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 3, Week 8, n=260
|
1.54 Percentage of blood by volume
Standard Deviation 3.453
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 3, Week 16, n=258
|
1.76 Percentage of blood by volume
Standard Deviation 3.508
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 3, Week 24, n=242
|
1.68 Percentage of blood by volume
Standard Deviation 3.709
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 12, Week 48, n=72
|
3.88 Percentage of blood by volume
Standard Deviation 4.439
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 13, Week 8, n=53
|
4.20 Percentage of blood by volume
Standard Deviation 3.776
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 13, Week 16, n=42
|
4.26 Percentage of blood by volume
Standard Deviation 3.803
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 13, Week 24, n=20
|
3.81 Percentage of blood by volume
Standard Deviation 3.930
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 3, Week 32, n=248
|
1.55 Percentage of blood by volume
Standard Deviation 3.676
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 3, Week 40, n=243
|
1.55 Percentage of blood by volume
Standard Deviation 3.703
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 3, Week 48, n=240
|
1.26 Percentage of blood by volume
Standard Deviation 3.726
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 4, Week 8, n=235
|
1.33 Percentage of blood by volume
Standard Deviation 3.908
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 4, Week 16, n=238
|
1.37 Percentage of blood by volume
Standard Deviation 3.759
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 4, Week 24, n=227
|
1.27 Percentage of blood by volume
Standard Deviation 3.680
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 4, Week 32, n=229
|
1.34 Percentage of blood by volume
Standard Deviation 3.955
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 4, Week 40, n=216
|
1.39 Percentage of blood by volume
Standard Deviation 3.779
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 4, Week 48, n=220
|
1.37 Percentage of blood by volume
Standard Deviation 4.033
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 5, Week 8, n=215
|
1.27 Percentage of blood by volume
Standard Deviation 4.031
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 5, Week 16, n=214
|
1.58 Percentage of blood by volume
Standard Deviation 3.917
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 5, Week 24, n=207
|
1.45 Percentage of blood by volume
Standard Deviation 3.905
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 5, Week 32, n=207
|
1.39 Percentage of blood by volume
Standard Deviation 3.979
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 5, Week 40, n=196
|
1.59 Percentage of blood by volume
Standard Deviation 4.031
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 5, Week 48, n=209
|
1.35 Percentage of blood by volume
Standard Deviation 3.929
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 6, Week 8, n=206
|
1.24 Percentage of blood by volume
Standard Deviation 4.128
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 6, Week 16, n=195
|
1.07 Percentage of blood by volume
Standard Deviation 4.114
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 6, Week 24, n=192
|
1.43 Percentage of blood by volume
Standard Deviation 3.648
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 6, Week 32, n=197
|
1.77 Percentage of blood by volume
Standard Deviation 3.822
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 6, Week 40, n=184
|
2.07 Percentage of blood by volume
Standard Deviation 4.089
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 6, Week 48, n=188
|
2.02 Percentage of blood by volume
Standard Deviation 3.961
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 7, Week 8, n=180
|
1.80 Percentage of blood by volume
Standard Deviation 3.808
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 7, Week 16, n=181
|
1.50 Percentage of blood by volume
Standard Deviation 3.883
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 7, Week 24, n=176
|
1.88 Percentage of blood by volume
Standard Deviation 3.840
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 7, Week 32, n=179
|
2.25 Percentage of blood by volume
Standard Deviation 3.824
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 7, Week 40, n=177
|
2.07 Percentage of blood by volume
Standard Deviation 3.907
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 7, Week 48, n=173
|
1.97 Percentage of blood by volume
Standard Deviation 3.958
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 8, Week 8, n=172
|
1.89 Percentage of blood by volume
Standard Deviation 3.909
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 8, Week 16, n=173
|
1.87 Percentage of blood by volume
Standard Deviation 3.729
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 8, Week 24, n=170
|
2.12 Percentage of blood by volume
Standard Deviation 4.065
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 8, Week 32, n=169
|
2.20 Percentage of blood by volume
Standard Deviation 3.954
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 8, Week 40, n=162
|
2.10 Percentage of blood by volume
Standard Deviation 4.122
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 8, Week 48, n=161
|
2.18 Percentage of blood by volume
Standard Deviation 4.029
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 9, Week 8, n=164
|
1.99 Percentage of blood by volume
Standard Deviation 3.995
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 9, Week 16, n=161
|
1.76 Percentage of blood by volume
Standard Deviation 4.114
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 9, Week 24, n=163
|
1.70 Percentage of blood by volume
Standard Deviation 4.020
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 9, Week 32, n=160
|
1.95 Percentage of blood by volume
Standard Deviation 4.171
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 9, Week 40, n=156
|
1.88 Percentage of blood by volume
Standard Deviation 4.302
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 9, Week 48, n=151
|
2.32 Percentage of blood by volume
Standard Deviation 4.174
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 13, Week 32, n=7
|
3.26 Percentage of blood by volume
Standard Deviation 4.547
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 10, Week 8, n=150
|
2.87 Percentage of blood by volume
Standard Deviation 4.087
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 10, Week 16, n=145
|
2.80 Percentage of blood by volume
Standard Deviation 4.050
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 10, Week 24, n=147
|
2.94 Percentage of blood by volume
Standard Deviation 4.046
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 10, Week 32, n=142
|
2.78 Percentage of blood by volume
Standard Deviation 4.046
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 10, Week 40, n=137
|
2.95 Percentage of blood by volume
Standard Deviation 3.884
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 10, Week 48, n=137
|
3.00 Percentage of blood by volume
Standard Deviation 4.245
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 11, Week 8, n=137
|
3.04 Percentage of blood by volume
Standard Deviation 4.176
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 11, Week 16, n=130
|
3.20 Percentage of blood by volume
Standard Deviation 4.155
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 11, Week 24, n=130
|
2.93 Percentage of blood by volume
Standard Deviation 4.331
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 11, Week 32, n=128
|
3.06 Percentage of blood by volume
Standard Deviation 3.976
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 11, Week 40, n=122
|
3.15 Percentage of blood by volume
Standard Deviation 4.098
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 11, Week 48, n=106
|
2.93 Percentage of blood by volume
Standard Deviation 4.356
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 12, Week 8, n=109
|
3.12 Percentage of blood by volume
Standard Deviation 4.223
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 12, Week 16, n=97
|
3.43 Percentage of blood by volume
Standard Deviation 4.321
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Year 13, Week 40, n=1
|
2.20 Percentage of blood by volume
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Exit, n=241
|
3.35 Percentage of blood by volume
Standard Deviation 4.596
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, 8-Week Follow-up, n=220
|
3.46 Percentage of blood by volume
Standard Deviation 4.690
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, 24-Week Follow-up , n=198
|
3.51 Percentage of blood by volume
Standard Deviation 4.627
|
PRIMARY outcome
Timeframe: Baseline and approximately up to 13 yearsPopulation: MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Extension 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.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=296 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 2, Week 24, n=278
|
3.2 grams per liter
Standard Deviation 12.20
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 2, Week 32, n=281
|
4.5 grams per liter
Standard Deviation 12.19
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 2, Week 40, n=262
|
4.9 grams per liter
Standard Deviation 12.15
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 2, Week 48, n=260
|
5.6 grams per liter
Standard Deviation 12.10
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 3, Week 8, n=260
|
4.8 grams per liter
Standard Deviation 12.01
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 3, Week 16, n=258
|
5.2 grams per liter
Standard Deviation 12.15
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 3, Week 24, n=242
|
5.4 grams per liter
Standard Deviation 12.47
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 3, Week 32, n=248
|
5.6 grams per liter
Standard Deviation 12.59
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 3, Week 40, n=243
|
5.9 grams per liter
Standard Deviation 12.90
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 3, Week 48, n=240
|
5.1 grams per liter
Standard Deviation 12.97
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 4, Week 8, n=235
|
5.2 grams per liter
Standard Deviation 13.49
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 4, Week 16, n=238
|
5.2 grams per liter
Standard Deviation 13.11
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 1, Week 8, n=287
|
0.1 grams per liter
Standard Deviation 9.42
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 1, Week 16, n=288
|
0.6 grams per liter
Standard Deviation 10.60
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 1, Week 24, n=293
|
1.5 grams per liter
Standard Deviation 9.86
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 1, Week 32, n=291
|
2.2 grams per liter
Standard Deviation 10.37
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 1, Week 40, n=287
|
2.8 grams per liter
Standard Deviation 10.84
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 1, Week 48, n=287
|
2.9 grams per liter
Standard Deviation 11.39
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 2, Week 8, n=288
|
2.2 grams per liter
Standard Deviation 11.62
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 2, Week 16, n=280
|
2.8 grams per liter
Standard Deviation 11.54
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 4, Week 24, n=227
|
4.1 grams per liter
Standard Deviation 13.05
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 4, Week 32, n=229
|
4.9 grams per liter
Standard Deviation 13.64
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 4, Week 40, n=216
|
4.9 grams per liter
Standard Deviation 13.25
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 4, Week 48, n=220
|
5.3 grams per liter
Standard Deviation 13.94
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 5, Week 8, n=215
|
5.1 grams per liter
Standard Deviation 14.20
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 5, Week 16, n=214
|
5.5 grams per liter
Standard Deviation 13.44
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 5, Week 24, n=207
|
4.4 grams per liter
Standard Deviation 13.73
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 5, Week 32, n=207
|
4.1 grams per liter
Standard Deviation 13.39
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 5, Week 40, n=196
|
5.2 grams per liter
Standard Deviation 14.31
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 5, Week 48, n=209
|
5.4 grams per liter
Standard Deviation 14.20
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 6, Week 8, n=206
|
5.5 grams per liter
Standard Deviation 14.72
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 6, Week 16, n=195
|
4.8 grams per liter
Standard Deviation 14.82
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 6, Week 24, n=192
|
5.6 grams per liter
Standard Deviation 12.80
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 6, Week 32, n=197
|
5.9 grams per liter
Standard Deviation 13.12
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 6, Week 40, n=184
|
6.6 grams per liter
Standard Deviation 13.96
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 6, Week 48, n=188
|
6.4 grams per liter
Standard Deviation 13.78
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 7, Week 8, n=180
|
6.3 grams per liter
Standard Deviation 13.58
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 7, Week 16, n=181
|
5.5 grams per liter
Standard Deviation 13.83
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 7, Week 24, n=176
|
6.0 grams per liter
Standard Deviation 13.51
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 7, Week 32, n=179
|
7.0 grams per liter
Standard Deviation 13.37
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 7, Week 40, n=177
|
6.4 grams per liter
Standard Deviation 13.61
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 7, Week 48, n=173
|
5.6 grams per liter
Standard Deviation 13.91
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 8, Week 8, n=172
|
5.7 grams per liter
Standard Deviation 13.69
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 8, Week 16, n=173
|
5.3 grams per liter
Standard Deviation 13.09
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 8, Week 24, n=170
|
6.1 grams per liter
Standard Deviation 14.13
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 8, Week 32, n=169
|
5.8 grams per liter
Standard Deviation 13.33
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 8, Week 40, n=162
|
4.9 grams per liter
Standard Deviation 13.93
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 8, Week 48, n=161
|
5.5 grams per liter
Standard Deviation 13.95
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 9, Week 8, n=164
|
5.5 grams per liter
Standard Deviation 13.79
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 9, Week 16, n=161
|
4.9 grams per liter
Standard Deviation 14.60
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 9, Week 24, n=163
|
4.6 grams per liter
Standard Deviation 14.32
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 9, Week 32, n=160
|
5.2 grams per liter
Standard Deviation 14.39
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 9, Week 40, n=156
|
3.9 grams per liter
Standard Deviation 15.20
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 9, Week 48, n=151
|
4.8 grams per liter
Standard Deviation 14.50
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 10, Week 8, n=150
|
6.5 grams per liter
Standard Deviation 14.46
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 10, Week 16, n=145
|
6.5 grams per liter
Standard Deviation 14.05
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 10, Week 24, n=147
|
6.5 grams per liter
Standard Deviation 14.20
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 10, Week 32, n=142
|
5.9 grams per liter
Standard Deviation 14.02
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 10, Week 40, n=137
|
6.0 grams per liter
Standard Deviation 13.29
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 10, Week 48, n=137
|
5.7 grams per liter
Standard Deviation 14.86
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 11, Week 8, n=137
|
5.9 grams per liter
Standard Deviation 14.40
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 11, Week 16, n=130
|
6.4 grams per liter
Standard Deviation 14.50
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 11, Week 24, n=130
|
5.9 grams per liter
Standard Deviation 15.02
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 11, Week 32, n=128
|
6.3 grams per liter
Standard Deviation 13.79
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 11, Week 40, n=122
|
6.7 grams per liter
Standard Deviation 14.03
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 11, Week 48, n=106
|
6.2 grams per liter
Standard Deviation 14.95
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 12, Week 8, n=109
|
6.8 grams per liter
Standard Deviation 14.55
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 12, Week 16, n=97
|
8.1 grams per liter
Standard Deviation 15.12
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 12, Week 24, n=86
|
8.9 grams per liter
Standard Deviation 16.83
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 12, Week 32, n=88
|
6.6 grams per liter
Standard Deviation 17.18
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 12, Week 40, n=83
|
7.0 grams per liter
Standard Deviation 15.41
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 12, Week 48, n=72
|
8.3 grams per liter
Standard Deviation 14.80
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 13, Week 8, n=53
|
8.4 grams per liter
Standard Deviation 12.37
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 13, Week 16, n=42
|
8.0 grams per liter
Standard Deviation 12.81
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 13, Week 24, n=20
|
6.3 grams per liter
Standard Deviation 12.01
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 13, Week 32, n=7
|
5.4 grams per liter
Standard Deviation 14.27
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Year 13, Week 40, n=1
|
3.0 grams per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, Exit, n=241
|
7.4 grams per liter
Standard Deviation 15.11
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, 8-Week Follow-up, n=220
|
6.7 grams per liter
Standard Deviation 15.46
|
|
Change From Baseline in Hemoglobin at the Indicated Time Points
Hemoglobin, 24-Week Follow-up , n=198
|
6.8 grams per liter
Standard Deviation 14.91
|
PRIMARY outcome
Timeframe: Baseline and approximately up to 13 yearsPopulation: MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Extension 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.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=296 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 9, Week 40, n=156
|
1.6 grams/liter
Standard Deviation 3.54
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 9, Week 48, n=151
|
1.9 grams/liter
Standard Deviation 3.55
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 10, Week 8, n=152
|
1.9 grams/liter
Standard Deviation 3.64
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 10, Week 16, n=143
|
2.1 grams/liter
Standard Deviation 3.55
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 10, Week 24, n=145
|
2.0 grams/liter
Standard Deviation 3.85
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 10, Week 32, n=142
|
2.1 grams/liter
Standard Deviation 4.05
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 10, Week 40, n=138
|
1.8 grams/liter
Standard Deviation 3.78
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 10, Week 48, n=135
|
2.0 grams/liter
Standard Deviation 3.52
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 11, Week 8, n=138
|
2.0 grams/liter
Standard Deviation 3.74
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 11, Week 16, n=128
|
2.2 grams/liter
Standard Deviation 3.58
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 11, Week 24, n=130
|
2.1 grams/liter
Standard Deviation 3.87
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 11, Week 32, n=125
|
1.8 grams/liter
Standard Deviation 3.89
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 11, Week 40, n=124
|
1.7 grams/liter
Standard Deviation 3.69
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 11, Week 48, n=108
|
1.8 grams/liter
Standard Deviation 3.91
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 12, Week 8, n=110
|
1.8 grams/liter
Standard Deviation 3.43
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 12, Week 16, n=97
|
1.9 grams/liter
Standard Deviation 3.68
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 12, Week 24, n=87
|
2.5 grams/liter
Standard Deviation 4.01
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 12, Week 32, n=84
|
1.9 grams/liter
Standard Deviation 4.01
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 12, Week 40, n=82
|
1.7 grams/liter
Standard Deviation 3.76
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 12, Week 48, n=72
|
2.1 grams/liter
Standard Deviation 3.67
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 13, Week 8, n=53
|
2.8 grams/liter
Standard Deviation 3.68
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 13, Week 16, n=42
|
2.3 grams/liter
Standard Deviation 3.61
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 13, Week 24, n=20
|
2.5 grams/liter
Standard Deviation 3.30
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 13, Week 32, n=7
|
1.1 grams/liter
Standard Deviation 2.67
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 13, Week 40, n=1
|
5.0 grams/liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Exit, n=248
|
2.0 grams/liter
Standard Deviation 4.02
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, 8-Week Follow-up, n=220
|
1.6 grams/liter
Standard Deviation 3.92
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, 24-Week Follow-up , n=200
|
2.2 grams/liter
Standard Deviation 4.24
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 1, Week 8, n=284
|
-1.3 grams/liter
Standard Deviation 4.31
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 1, Week 16, n=286
|
-1.8 grams/liter
Standard Deviation 4.63
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 1, Week 24, n=292
|
-1.5 grams/liter
Standard Deviation 4.76
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 1, Week 32, n=287
|
-1.7 grams/liter
Standard Deviation 4.69
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 1, Week 40, n=284
|
-1.6 grams/liter
Standard Deviation 5.0
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 1, Week 48, n=287
|
-2.0 grams/liter
Standard Deviation 5.01
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 2, Week 8, n=288
|
-2.1 grams/liter
Standard Deviation 4.74
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 2, Week 16, n=278
|
-2.5 grams/liter
Standard Deviation 4.66
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 2, Week 24, n=273
|
-2.9 grams/liter
Standard Deviation 5.07
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 2, Week 32, n=284
|
-2.4 grams/liter
Standard Deviation 5.13
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 2, Week 40, n=264
|
-2.4 grams/liter
Standard Deviation 4.87
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 2, Week 48, n=269
|
-1.5 grams/liter
Standard Deviation 5.18
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 3, Week 8, n=265
|
-2.2 grams/liter
Standard Deviation 5.49
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 3, Week 16, n=260
|
-2.0 grams/liter
Standard Deviation 5.19
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 3, Week 24, n=244
|
-1.9 grams/liter
Standard Deviation 5.63
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 3, Week 32, n=249
|
-1.8 grams/liter
Standard Deviation 5.19
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 3, Week 40, n=245
|
-1.6 grams/liter
Standard Deviation 5.34
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 3, Week 48, n=244
|
-1.8 grams/liter
Standard Deviation 5.16
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 4, Week 8, n=239
|
-2.1 grams/liter
Standard Deviation 5.27
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 4, Week 16, n=238
|
-1.8 grams/liter
Standard Deviation 4.93
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 4, Week 24, n=227
|
-2.5 grams/liter
Standard Deviation 5.06
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 4, Week 32, n=233
|
-2.3 grams/liter
Standard Deviation 5.02
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 4, Week 40, n=220
|
-2.8 grams/liter
Standard Deviation 4.97
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 4, Week 48, n=218
|
-2.2 grams/liter
Standard Deviation 5.44
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 5, Week 8, n=218
|
-2.5 grams/liter
Standard Deviation 5.34
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 5, Week 16, n=214
|
-2.6 grams/liter
Standard Deviation 5.09
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 5, Week 24, n=211
|
-3.2 grams/liter
Standard Deviation 5.22
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 5, Week 32, n=211
|
-2.5 grams/liter
Standard Deviation 5.05
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 5, Week 40, n=198
|
-2.9 grams/liter
Standard Deviation 5.47
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 5, Week 48, n=207
|
-2.8 grams/liter
Standard Deviation 5.67
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 6, Week 8, n=206
|
-3.1 grams/liter
Standard Deviation 5.39
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 6, Week 16, n=198
|
-3.4 grams/liter
Standard Deviation 5.75
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 6, Week 24, n=190
|
-3.5 grams/liter
Standard Deviation 5.6
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 6, Week 32, n=193
|
-3.0 grams/liter
Standard Deviation 5.77
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 6, Week 40, n=185
|
-3.4 grams/liter
Standard Deviation 5.84
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 6, Week 48, n=186
|
-3.5 grams/liter
Standard Deviation 6.0
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 7, Week 8, n=179
|
-3.6 grams/liter
Standard Deviation 5.52
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 7, Week 16, n=179
|
-4.1 grams/liter
Standard Deviation 5.87
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 7, Week 24, n=173
|
-3.9 grams/liter
Standard Deviation 5.96
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 7, Week 32, n=180
|
-3.7 grams/liter
Standard Deviation 5.68
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 7, Week 40, n=175
|
-4.2 grams/liter
Standard Deviation 5.39
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 7, Week 48, n=175
|
-4.5 grams/liter
Standard Deviation 5.6
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 8, Week 8, n=171
|
-4.6 grams/liter
Standard Deviation 5.75
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 8, Week 16, n=170
|
-4.7 grams/liter
Standard Deviation 5.37
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 8, Week 24, n=168
|
-4.7 grams/liter
Standard Deviation 5.54
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 8, Week 32, n=168
|
-4.5 grams/liter
Standard Deviation 5.46
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 8, Week 40, n=162
|
-5.2 grams/liter
Standard Deviation 5.36
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 8, Week 48, n=159
|
-4.5 grams/liter
Standard Deviation 5.3
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 9, Week 8, n=164
|
-4.5 grams/liter
Standard Deviation 5.75
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 9, Week 16, n=162
|
-4.8 grams/liter
Standard Deviation 5.34
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 9, Week 24, n=161
|
-5.0 grams/liter
Standard Deviation 5.32
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 9, Week 32, n=163
|
-4.8 grams/liter
Standard Deviation 5.18
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 9, Week 40, n=156
|
-5.4 grams/liter
Standard Deviation 5.51
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 9, Week 48, n=151
|
-5.1 grams/liter
Standard Deviation 5.6
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 10, Week 8, n=152
|
-5.2 grams/liter
Standard Deviation 5.86
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 10, Week 16, n=143
|
-5.0 grams/liter
Standard Deviation 5.79
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 10, Week 24, n=145
|
-5.2 grams/liter
Standard Deviation 5.88
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 10, Week 32, n=142
|
-5.1 grams/liter
Standard Deviation 5.98
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 10, Week 40, n=138
|
-5.4 grams/liter
Standard Deviation 5.98
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 10, Week 48, n=135
|
-5.4 grams/liter
Standard Deviation 5.62
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 11, Week 8, n=138
|
-5.4 grams/liter
Standard Deviation 6.15
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 11, Week 16, n=128
|
-5.1 grams/liter
Standard Deviation 5.51
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 11, Week 24, n=130
|
-5.1 grams/liter
Standard Deviation 6.15
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 11, Week 32, n=125
|
-5.6 grams/liter
Standard Deviation 6.12
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 11, Week 40, n=124
|
-5.6 grams/liter
Standard Deviation 5.81
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 11, Week 48, n=108
|
-5.4 grams/liter
Standard Deviation 6.42
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 12, Week 8, n=110
|
-5.0 grams/liter
Standard Deviation 5.65
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 12, Week 16, n=97
|
-5.1 grams/liter
Standard Deviation 5.86
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 12, Week 24, n=87
|
-4.6 grams/liter
Standard Deviation 6.26
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 12, Week 32, n=84
|
-5.1 grams/liter
Standard Deviation 5.82
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 12, Week 40, n=82
|
-5.7 grams/liter
Standard Deviation 5.35
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 12, Week 48, n=72
|
-5.0 grams/liter
Standard Deviation 5.86
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 13, Week 8, n=53
|
-4.8 grams/liter
Standard Deviation 6.0
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 13, Week 16, n=42
|
-5.6 grams/liter
Standard Deviation 6.04
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 13, Week 24, n=20
|
-4.4 grams/liter
Standard Deviation 6.3
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 13, Week 32, n=7
|
-8.9 grams/liter
Standard Deviation 5.08
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Year 13, Week 40, n=1
|
1.0 grams/liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, Exit, n=248
|
-3.2 grams/liter
Standard Deviation 6.12
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, 8-Week Follow-up, n=220
|
-3.7 grams/liter
Standard Deviation 6.39
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Protein, 24-Week Follow-up , n=200
|
-2.6 grams/liter
Standard Deviation 6.72
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 1, Week 8, n=284
|
0.1 grams/liter
Standard Deviation 2.36
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 1, Week 16, n=286
|
-0.2 grams/liter
Standard Deviation 2.68
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 1, Week 24, n=292
|
0.2 grams/liter
Standard Deviation 2.74
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 1, Week 32, n=287
|
0.1 grams/liter
Standard Deviation 2.91
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 1, Week 40, n=284
|
0.2 grams/liter
Standard Deviation 3.06
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 1, Week 48, n=287
|
0.3 grams/liter
Standard Deviation 3.21
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 2, Week 8, n=288
|
0.4 grams/liter
Standard Deviation 2.84
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 2, Week 16, n=278
|
0.4 grams/liter
Standard Deviation 2.95
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 2, Week 24, n=273
|
0.1 grams/liter
Standard Deviation 3.17
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 2, Week 32, n=284
|
0.7 grams/liter
Standard Deviation 3.08
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 2, Week 40, n=264
|
0.8 grams/liter
Standard Deviation 2.92
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 2, Week 48, n=269
|
1.1 grams/liter
Standard Deviation 3.25
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 3, Week 8, n=265
|
0.7 grams/liter
Standard Deviation 3.39
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 3, Week 16, n=260
|
1.0 grams/liter
Standard Deviation 3.05
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 3, Week 24, n=244
|
1.2 grams/liter
Standard Deviation 3.23
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 3, Week 32, n=249
|
1.3 grams/liter
Standard Deviation 3.13
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 3, Week 40, n=245
|
1.4 grams/liter
Standard Deviation 3.11
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 3, Week 48, n=244
|
1.5 grams/liter
Standard Deviation 3.12
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 4, Week 8, n=239
|
1.4 grams/liter
Standard Deviation 3.36
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 4, Week 16, n=238
|
1.3 grams/liter
Standard Deviation 3.21
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 4, Week 24, n=227
|
1.2 grams/liter
Standard Deviation 3.15
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 4, Week 32, n=233
|
1.3 grams/liter
Standard Deviation 3.31
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 4, Week 40, n=220
|
1.2 grams/liter
Standard Deviation 3.29
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 4, Week 48, n=218
|
1.6 grams/liter
Standard Deviation 3.57
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 5, Week 8, n=218
|
1.6 grams/liter
Standard Deviation 3.37
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 5, Week 16, n=214
|
1.5 grams/liter
Standard Deviation 3.07
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 5, Week 24, n=211
|
1.5 grams/liter
Standard Deviation 3.36
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 5, Week 32, n=211
|
1.9 grams/liter
Standard Deviation 3.34
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 5, Week 40, n=198
|
1.8 grams/liter
Standard Deviation 3.40
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 5, Week 48, n=207
|
1.7 grams/liter
Standard Deviation 3.41
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 6, Week 8, n=206
|
1.8 grams/liter
Standard Deviation 3.27
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 6, Week 16, n=198
|
1.5 grams/liter
Standard Deviation 3.72
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 6, Week 24, n=190
|
1.6 grams/liter
Standard Deviation 3.32
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 6, Week 32, n=193
|
2.0 grams/liter
Standard Deviation 3.71
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 6, Week 40, n=185
|
1.9 grams/liter
Standard Deviation 3.52
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 6, Week 48, n=186
|
1.9 grams/liter
Standard Deviation 3.64
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 7, Week 8, n=179
|
1.9 grams/liter
Standard Deviation 3.36
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 7, Week 16, n=179
|
1.7 grams/liter
Standard Deviation 3.57
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 7, Week 24, n=173
|
1.7 grams/liter
Standard Deviation 3.88
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 7, Week 32, n=180
|
1.9 grams/liter
Standard Deviation 3.53
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 7, Week 40, n=175
|
1.6 grams/liter
Standard Deviation 3.41
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 7, Week 48, n=175
|
1.6 grams/liter
Standard Deviation 3.60
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 8, Week 8, n=171
|
1.7 grams/liter
Standard Deviation 3.61
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 8, Week 16, n=170
|
1.5 grams/liter
Standard Deviation 3.31
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 8, Week 24, n=168
|
1.6 grams/liter
Standard Deviation 3.47
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 8, Week 32, n=168
|
1.7 grams/liter
Standard Deviation 3.25
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 8, Week 40, n=162
|
1.3 grams/liter
Standard Deviation 3.46
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 8, Week 48, n=159
|
1.7 grams/liter
Standard Deviation 3.56
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 9, Week 8, n=164
|
2.0 grams/liter
Standard Deviation 3.97
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 9, Week 16, n=162
|
1.9 grams/liter
Standard Deviation 3.58
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 9, Week 24, n=161
|
1.6 grams/liter
Standard Deviation 3.38
|
|
Change From Baseline in Albumin and Protein at the Indicated Time Points
Albumin, Year 9, Week 32, n=163
|
1.9 grams/liter
Standard Deviation 3.27
|
PRIMARY outcome
Timeframe: Baseline and approximately up to 13 yearsPopulation: MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Extension 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.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=296 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 1, Week 8, n=284
|
0.0189 millimoles per liter
Standard Deviation 1.4412
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 1, Week 16, n=286
|
-0.0836 millimoles per liter
Standard Deviation 1.4928
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 1, Week 24, n=292
|
-0.0281 millimoles per liter
Standard Deviation 1.5612
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 1, Week 32, n=287
|
-0.0199 millimoles per liter
Standard Deviation 1.4020
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 1, Week 40, n=284
|
-0.1823 millimoles per liter
Standard Deviation 1.3626
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 1, Week 48, n=287
|
0.0224 millimoles per liter
Standard Deviation 1.6607
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 2, Week 8, n=288
|
-0.0607 millimoles per liter
Standard Deviation 1.5714
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 2, Week 16, n=278
|
-0.0796 millimoles per liter
Standard Deviation 1.6220
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 2, Week 24, n=273
|
-0.0850 millimoles per liter
Standard Deviation 1.6900
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 2, Week 32, n=284
|
-0.0779 millimoles per liter
Standard Deviation 1.8263
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 2, Week 40, n=264
|
-0.1136 millimoles per liter
Standard Deviation 1.7293
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 2, Week 48, n=269
|
-0.0571 millimoles per liter
Standard Deviation 1.7035
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 3, Week 8, n=265
|
-0.0620 millimoles per liter
Standard Deviation 1.6580
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 5, Week 24, n=211
|
0.2 millimoles per liter
Standard Deviation 3.05
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 5, Week 32, n=211
|
-0.2 millimoles per liter
Standard Deviation 3.08
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 3, Week 16, n=260
|
-0.0357 millimoles per liter
Standard Deviation 1.7963
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 3, Week 24, n=244
|
0.0775 millimoles per liter
Standard Deviation 1.9949
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 3, Week 32, n=249
|
0.0129 millimoles per liter
Standard Deviation 1.8758
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 5, Week 40, n=198
|
0.1 millimoles per liter
Standard Deviation 2.97
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 5, Week 48, n=207
|
-0.3 millimoles per liter
Standard Deviation 3.00
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 6, Week 8, n=206
|
-0.2 millimoles per liter
Standard Deviation 3.11
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 3, Week 40, n=245
|
0.0903 millimoles per liter
Standard Deviation 1.9922
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 3, Week 48, n=244
|
0.1346 millimoles per liter
Standard Deviation 2.1131
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 4, Week 8, n=239
|
0.1658 millimoles per liter
Standard Deviation 1.9076
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 4, Week 16, n=238
|
0.0900 millimoles per liter
Standard Deviation 1.7799
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 6, Week 16, n=198
|
-0.2 millimoles per liter
Standard Deviation 3.23
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 4, Week 24, n=227
|
0.1258 millimoles per liter
Standard Deviation 2.0386
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 4, Week 32, n=233
|
0.0812 millimoles per liter
Standard Deviation 1.8611
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 4, Week 40, n=220
|
0.0325 millimoles per liter
Standard Deviation 2.0164
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 4, Week 48, n=218
|
0.2948 millimoles per liter
Standard Deviation 2.3008
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 5, Week 8, n=218
|
0.2047 millimoles per liter
Standard Deviation 2.0007
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 5, Week 16, n=214
|
0.2669 millimoles per liter
Standard Deviation 1.8316
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 5, Week 24, n=211
|
0.2064 millimoles per liter
Standard Deviation 2.0558
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 5, Week 32, n=211
|
0.0558 millimoles per liter
Standard Deviation 1.7962
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 5, Week 40, n=198
|
0.2632 millimoles per liter
Standard Deviation 2.0944
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 5, Week 48, n=207
|
0.1794 millimoles per liter
Standard Deviation 2.0505
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 6, Week 8, n=206
|
0.2773 millimoles per liter
Standard Deviation 1.8758
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 6, Week 16, n=198
|
0.2632 millimoles per liter
Standard Deviation 1.8983
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 6, Week 24, n=190
|
0.1447 millimoles per liter
Standard Deviation 2.0291
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 6, Week 32, n=193
|
0.2960 millimoles per liter
Standard Deviation 2.1213
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 6, Week 40, n=185
|
0.3184 millimoles per liter
Standard Deviation 2.1795
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 6, Week 48, n=186
|
0.3647 millimoles per liter
Standard Deviation 1.9359
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 7, Week 8, n=179
|
0.2852 millimoles per liter
Standard Deviation 2.1528
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 7, Week 16, n=179
|
0.3191 millimoles per liter
Standard Deviation 2.0398
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 7, Week 24, n=173
|
0.2683 millimoles per liter
Standard Deviation 2.5539
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 7, Week 32, n=180
|
0.1686 millimoles per liter
Standard Deviation 2.1547
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 7, Week 40, n=175
|
0.2285 millimoles per liter
Standard Deviation 1.9007
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 7, Week 48, n=175
|
0.2326 millimoles per liter
Standard Deviation 2.3098
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 8, Week 8, n=171
|
0.2234 millimoles per liter
Standard Deviation 2.3330
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 8, Week 16, n=170
|
0.1932 millimoles per liter
Standard Deviation 2.1219
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 8, Week 24, n=168
|
0.2189 millimoles per liter
Standard Deviation 2.0413
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 8, Week 32, n=168
|
0.0680 millimoles per liter
Standard Deviation 2.0995
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 8, Week 40, n=162
|
0.1234 millimoles per liter
Standard Deviation 2.0504
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 8, Week 48, n=159
|
0.2560 millimoles per liter
Standard Deviation 1.8494
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 9, Week 8, n=164
|
0.1197 millimoles per liter
Standard Deviation 1.6667
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 9, Week 16, n=162
|
0.1719 millimoles per liter
Standard Deviation 1.8226
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 9, Week 24, n=161
|
0.1397 millimoles per liter
Standard Deviation 1.9255
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 9, Week 32, n=163
|
0.2979 millimoles per liter
Standard Deviation 1.9020
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 9, Week 40, n=156
|
0.1304 millimoles per liter
Standard Deviation 1.8027
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 9, Week 48, n=151
|
0.0804 millimoles per liter
Standard Deviation 1.9432
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 10, Week 8, n=152
|
0.1973 millimoles per liter
Standard Deviation 2.1517
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 10, Week 16, n=143
|
0.1098 millimoles per liter
Standard Deviation 1.8916
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 10, Week 24, n=145
|
0.1847 millimoles per liter
Standard Deviation 1.8330
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 10, Week 32, n=142
|
0.1911 millimoles per liter
Standard Deviation 1.8808
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 10, Week 40, n=138
|
-0.0440 millimoles per liter
Standard Deviation 1.8103
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 10, Week 48, n=135
|
0.0926 millimoles per liter
Standard Deviation 1.8219
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 11, Week 8, n=138
|
0.1837 millimoles per liter
Standard Deviation 2.0925
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 11, Week 16, n=128
|
0.1060 millimoles per liter
Standard Deviation 1.9866
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 11, Week 24, n=130
|
0.1291 millimoles per liter
Standard Deviation 1.8654
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 11, Week 32, n=125
|
0.0029 millimoles per liter
Standard Deviation 1.7563
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 11, Week 40, n=124
|
0.0576 millimoles per liter
Standard Deviation 1.9364
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 11, Week 48, n=108
|
-0.0926 millimoles per liter
Standard Deviation 1.8134
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 12, Week 8, n=110
|
0.1266 millimoles per liter
Standard Deviation 2.0325
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 12, Week 16, n=97
|
0.2687 millimoles per liter
Standard Deviation 1.9561
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 12, Week 24, n=87
|
0.0780 millimoles per liter
Standard Deviation 1.8996
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 12, Week 32, n=84
|
-0.2167 millimoles per liter
Standard Deviation 1.6336
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 12, Week 40, n=82
|
-0.1741 millimoles per liter
Standard Deviation 1.8725
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 12, Week 48, n=72
|
-0.0992 millimoles per liter
Standard Deviation 1.8146
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 13, Week 8, n=53
|
0.0808 millimoles per liter
Standard Deviation 1.7244
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 13, Week 16, n=42
|
0.5695 millimoles per liter
Standard Deviation 1.6690
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 13, Week 24, n=20
|
0.1964 millimoles per liter
Standard Deviation 1.0708
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 13, Week 32, n=7
|
-0.4590 millimoles per liter
Standard Deviation 1.6961
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Year 13, Week 40, n=1
|
-1.7850 millimoles per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, Exit, n=248
|
0.2519 millimoles per liter
Standard Deviation 2.3492
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, 8-Week Follow-up, n=220
|
0.0471 millimoles per liter
Standard Deviation 2.3709
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
BUN, 24-Week Follow-up , n=200
|
-0.0268 millimoles per liter
Standard Deviation 2.1652
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 1, Week 8, n=284
|
-0.0264 millimoles per liter
Standard Deviation 1.4683
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 1, Week 16, n=286
|
0.0314 millimoles per liter
Standard Deviation 1.5221
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 1, Week 24, n=292
|
-0.0375 millimoles per liter
Standard Deviation 1.6213
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 1, Week 32, n=287
|
-0.0265 millimoles per liter
Standard Deviation 1.6241
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 1, Week 40, n=284
|
0.0031 millimoles per liter
Standard Deviation 1.4590
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 1, Week 48, n=287
|
0.0232 millimoles per liter
Standard Deviation 1.8176
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 2, Week 8, n=288
|
0.0168 millimoles per liter
Standard Deviation 1.6196
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 2, Week 16, n=278
|
0.0327 millimoles per liter
Standard Deviation 1.6027
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 2, Week 24, n=273
|
0.1194 millimoles per liter
Standard Deviation 1.6450
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 2, Week 32, n=284
|
0.0510 millimoles per liter
Standard Deviation 1.4905
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 2, Week 40, n=264
|
0.0639 millimoles per liter
Standard Deviation 1.5995
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 2, Week 48, n=269
|
0.0017 millimoles per liter
Standard Deviation 1.6178
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 3, Week 8, n=265
|
-0.0161 millimoles per liter
Standard Deviation 1.3878
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 3, Week 16, n=260
|
-0.1223 millimoles per liter
Standard Deviation 1.5965
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 3, Week 24, n=244
|
0.0348 millimoles per liter
Standard Deviation 1.9713
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 3, Week 32, n=249
|
-0.0887 millimoles per liter
Standard Deviation 1.7057
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 3, Week 40, n=245
|
-0.0242 millimoles per liter
Standard Deviation 1.3532
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 3, Week 48, n=244
|
-0.0271 millimoles per liter
Standard Deviation 2.1535
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 4, Week 8, n=239
|
-0.0451 millimoles per liter
Standard Deviation 1.6912
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 4, Week 16, n=238
|
-0.1199 millimoles per liter
Standard Deviation 1.7495
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 4, Week 24, n=227
|
-0.1142 millimoles per liter
Standard Deviation 1.8087
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 4, Week 32, n=233
|
0.0741 millimoles per liter
Standard Deviation 1.7592
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 4, Week 40, n=220
|
0.1204 millimoles per liter
Standard Deviation 2.0200
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 4, Week 48, n=218
|
-0.0410 millimoles per liter
Standard Deviation 1.9212
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 5, Week 8, n=218
|
0.1350 millimoles per liter
Standard Deviation 1.8331
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 5, Week 16, n=214
|
0.0999 millimoles per liter
Standard Deviation 1.9373
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 5, Week 24, n=211
|
0.2402 millimoles per liter
Standard Deviation 1.7548
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 5, Week 32, n=211
|
-0.0873 millimoles per liter
Standard Deviation 1.5258
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 5, Week 40, n=198
|
0.0535 millimoles per liter
Standard Deviation 1.7957
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 5, Week 48, n=207
|
-0.0107 millimoles per liter
Standard Deviation 1.3758
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 6, Week 8, n=206
|
0.0385 millimoles per liter
Standard Deviation 2.0336
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 6, Week 16, n=198
|
0.0112 millimoles per liter
Standard Deviation 1.6676
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 6, Week 24, n=190
|
0.0894 millimoles per liter
Standard Deviation 2.1875
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 6, Week 32, n=193
|
0.0380 millimoles per liter
Standard Deviation 1.9025
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 6, Week 40, n=185
|
0.0939 millimoles per liter
Standard Deviation 1.9242
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 6, Week 48, n=186
|
-0.0176 millimoles per liter
Standard Deviation 1.7507
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 7, Week 8, n=179
|
0.1098 millimoles per liter
Standard Deviation 1.9999
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 7, Week 16, n=179
|
0.0558 millimoles per liter
Standard Deviation 2.0164
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 7, Week 24, n=173
|
0.2118 millimoles per liter
Standard Deviation 2.3731
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 7, Week 32, n=180
|
0.1588 millimoles per liter
Standard Deviation 1.6939
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 7, Week 40, n=175
|
0.1380 millimoles per liter
Standard Deviation 2.1777
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 7, Week 48, n=175
|
0.0698 millimoles per liter
Standard Deviation 1.9178
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 8, Week 8, n=171
|
0.0217 millimoles per liter
Standard Deviation 2.0227
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 8, Week 16, n=170
|
0.0307 millimoles per liter
Standard Deviation 1.9951
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 8, Week 24, n=168
|
0.0430 millimoles per liter
Standard Deviation 1.5670
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 8, Week 32, n=168
|
0.2029 millimoles per liter
Standard Deviation 2.1886
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 8, Week 40, n=162
|
0.3481 millimoles per liter
Standard Deviation 1.8895
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 8, Week 48, n=159
|
0.2821 millimoles per liter
Standard Deviation 2.3294
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 9, Week 8, n=164
|
0.2065 millimoles per liter
Standard Deviation 2.3063
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 9, Week 16, n=162
|
0.2457 millimoles per liter
Standard Deviation 2.2362
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 9, Week 24, n=161
|
0.2065 millimoles per liter
Standard Deviation 2.3096
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 9, Week 32, n=163
|
0.1437 millimoles per liter
Standard Deviation 1.7266
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 9, Week 40, n=156
|
0.2619 millimoles per liter
Standard Deviation 2.4664
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 9, Week 48, n=151
|
0.3110 millimoles per liter
Standard Deviation 1.7497
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 10, Week 8, n=152
|
0.2184 millimoles per liter
Standard Deviation 2.5367
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 10, Week 16, n=143
|
0.2713 millimoles per liter
Standard Deviation 2.2189
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 10, Week 24, n=145
|
0.2695 millimoles per liter
Standard Deviation 1.9119
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 10, Week 32, n=142
|
0.0192 millimoles per liter
Standard Deviation 2.0309
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 10, Week 40, n=138
|
0.2277 millimoles per liter
Standard Deviation 1.8718
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 10, Week 48, n=135
|
0.2919 millimoles per liter
Standard Deviation 2.2420
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 11, Week 8, n=138
|
0.3524 millimoles per liter
Standard Deviation 2.4257
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 11, Week 16, n=128
|
0.1778 millimoles per liter
Standard Deviation 2.4430
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 11, Week 24, n=130
|
0.2818 millimoles per liter
Standard Deviation 1.9155
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 11, Week 32, n=125
|
0.2203 millimoles per liter
Standard Deviation 2.2945
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 11, Week 40, n=124
|
0.0877 millimoles per liter
Standard Deviation 2.0564
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 11, Week 48, n=108
|
0.1778 millimoles per liter
Standard Deviation 2.2984
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 12, Week 8, n=110
|
0.2861 millimoles per liter
Standard Deviation 2.5700
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 12, Week 16, n=97
|
0.0830 millimoles per liter
Standard Deviation 2.1347
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 12, Week 24, n=87
|
0.1448 millimoles per liter
Standard Deviation 1.8433
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 12, Week 32, n=84
|
-0.0886 millimoles per liter
Standard Deviation 2.2813
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 12, Week 40, n=82
|
0.3209 millimoles per liter
Standard Deviation 1.4176
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 12, Week 48, n=72
|
0.3870 millimoles per liter
Standard Deviation 1.4519
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 13, Week 8, n=53
|
0.3561 millimoles per liter
Standard Deviation 1.1963
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 13, Week 16, n=42
|
0.2498 millimoles per liter
Standard Deviation 1.2196
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 13, Week 24, n=20
|
0.4663 millimoles per liter
Standard Deviation 1.6396
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 13, Week 32, n=7
|
0.3727 millimoles per liter
Standard Deviation 0.8144
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Year 13, Week 40, n=1
|
-0.8326 millimoles per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, Exit, n=248
|
0.1744 millimoles per liter
Standard Deviation 1.9656
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, 8-Week Follow-up, n=220
|
0.2707 millimoles per liter
Standard Deviation 1.5879
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Glucose, 24-Week Follow-up , n=200
|
0.3295 millimoles per liter
Standard Deviation 2.1561
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 1, Week 8, n=281
|
-0.0033 millimoles per liter
Standard Deviation 0.1012
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 1, Week 16, n=283
|
-0.0025 millimoles per liter
Standard Deviation 0.1175
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 1, Week 24, n=287
|
0.0156 millimoles per liter
Standard Deviation 0.1036
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 1, Week 32, n=283
|
0.0159 millimoles per liter
Standard Deviation 0.1067
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 1, Week 40, n=282
|
0.0203 millimoles per liter
Standard Deviation 0.1102
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 1, Week 48, n=284
|
0.0011 millimoles per liter
Standard Deviation 0.1193
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 2, Week 8, n=288
|
0.0010 millimoles per liter
Standard Deviation 0.1093
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 2, Week 16, n=276
|
-0.0080 millimoles per liter
Standard Deviation 0.1104
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 2, Week 24, n=269
|
-0.0180 millimoles per liter
Standard Deviation 0.1171
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 2, Week 32, n=284
|
-0.0131 millimoles per liter
Standard Deviation 0.1120
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 2, Week 40, n=261
|
-0.0071 millimoles per liter
Standard Deviation 0.1091
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 2, Week 48, n=267
|
-0.0081 millimoles per liter
Standard Deviation 0.1158
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 3, Week 8, n=262
|
-0.0273 millimoles per liter
Standard Deviation 0.1291
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 3, Week 16, n=258
|
-0.0189 millimoles per liter
Standard Deviation 0.1102
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 3, Week 24, n=241
|
-0.0205 millimoles per liter
Standard Deviation 0.1165
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 3, Week 32, n=245
|
-0.0205 millimoles per liter
Standard Deviation 0.1044
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 3, Week 40, n=242
|
-0.0121 millimoles per liter
Standard Deviation 0.1122
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 3, Week 48, n=239
|
-0.0156 millimoles per liter
Standard Deviation 0.1112
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 4, Week 8, n=237
|
-0.0183 millimoles per liter
Standard Deviation 0.1147
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 4, Week 16, n=235
|
-0.0264 millimoles per liter
Standard Deviation 0.1118
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 4, Week 24, n=225
|
-0.0250 millimoles per liter
Standard Deviation 0.1140
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 4, Week 32, n=230
|
-0.0221 millimoles per liter
Standard Deviation 0.1074
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 4, Week 40, n=218
|
-0.0220 millimoles per liter
Standard Deviation 0.1105
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 4, Week 48, n=214
|
-0.0192 millimoles per liter
Standard Deviation 0.1162
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 5, Week 8, n=217
|
-0.0297 millimoles per liter
Standard Deviation 0.1112
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 5, Week 16, n=213
|
-0.0274 millimoles per liter
Standard Deviation 0.1149
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 5, Week 24, n=206
|
-0.0292 millimoles per liter
Standard Deviation 0.1179
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 5, Week 32, n=211
|
-0.0104 millimoles per liter
Standard Deviation 0.1132
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 5, Week 40, n=196
|
-0.0140 millimoles per liter
Standard Deviation 0.1166
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 5, Week 48, n=207
|
-0.0036 millimoles per liter
Standard Deviation 0.1133
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 6, Week 8, n=205
|
-0.0127 millimoles per liter
Standard Deviation 0.1086
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 6, Week 16, n=198
|
-0.0263 millimoles per liter
Standard Deviation 0.1269
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 6, Week 24, n=189
|
-0.0037 millimoles per liter
Standard Deviation 0.1155
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 6, Week 32, n=192
|
-0.0044 millimoles per liter
Standard Deviation 0.1150
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 6, Week 40, n=181
|
-0.0123 millimoles per liter
Standard Deviation 0.1068
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 6, Week 48, n=186
|
-0.0025 millimoles per liter
Standard Deviation 0.1107
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 7, Week 8, n=177
|
-0.0162 millimoles per liter
Standard Deviation 0.1076
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 7, Week 16, n=178
|
-0.0175 millimoles per liter
Standard Deviation 0.1217
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 7, Week 24, n=171
|
-0.0163 millimoles per liter
Standard Deviation 0.1169
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 7, Week 32, n=179
|
-0.0114 millimoles per liter
Standard Deviation 0.1097
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 7, Week 40, n=172
|
-0.0144 millimoles per liter
Standard Deviation 0.1111
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 7, Week 48, n=175
|
-0.0234 millimoles per liter
Standard Deviation 0.1058
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 8, Week 8, n=170
|
-0.0203 millimoles per liter
Standard Deviation 0.1144
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 8, Week 16, n=169
|
-0.0176 millimoles per liter
Standard Deviation 0.1099
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 8, Week 24, n=167
|
-0.0121 millimoles per liter
Standard Deviation 0.1047
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 8, Week 32, n=166
|
-0.0153 millimoles per liter
Standard Deviation 0.1015
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 8, Week 40, n=161
|
-0.0254 millimoles per liter
Standard Deviation 0.1111
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 8, Week 48, n=159
|
-0.0210 millimoles per liter
Standard Deviation 0.1138
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 9, Week 8, n=163
|
-0.0167 millimoles per liter
Standard Deviation 0.1283
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 9, Week 16, n=160
|
-0.0198 millimoles per liter
Standard Deviation 0.1181
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 9, Week 24, n=160
|
-0.0253 millimoles per liter
Standard Deviation 0.1231
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 9, Week 32, n=162
|
-0.0205 millimoles per liter
Standard Deviation 0.1150
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 9, Week 40, n=156
|
-0.0157 millimoles per liter
Standard Deviation 0.1246
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 9, Week 48, n=150
|
-0.0075 millimoles per liter
Standard Deviation 0.1116
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 10, Week 8, n=151
|
-0.0114 millimoles per liter
Standard Deviation 0.1050
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 10, Week 16, n=143
|
0.0026 millimoles per liter
Standard Deviation 0.1015
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 10, Week 24, n=145
|
-0.0067 millimoles per liter
Standard Deviation 0.1115
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 10, Week 32, n=140
|
-0.0066 millimoles per liter
Standard Deviation 0.1109
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 10, Week 40, n=137
|
-0.0067 millimoles per liter
Standard Deviation 0.1157
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 10, Week 48, n=135
|
-0.0033 millimoles per liter
Standard Deviation 0.1268
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 11, Week 8, n=138
|
-0.0043 millimoles per liter
Standard Deviation 0.1185
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 11, Week 16, n=128
|
-0.0033 millimoles per liter
Standard Deviation 0.1078
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 11, Week 24, n=129
|
-0.0116 millimoles per liter
Standard Deviation 0.1304
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 11, Week 32, n=124
|
-0.0131 millimoles per liter
Standard Deviation 0.1131
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 11, Week 40, n=124
|
-0.0093 millimoles per liter
Standard Deviation 0.1157
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 11, Week 48, n=107
|
-0.0061 millimoles per liter
Standard Deviation 0.1238
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 12, Week 8, n=109
|
-0.0153 millimoles per liter
Standard Deviation 0.1214
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 12, Week 16, n=97
|
-0.0005 millimoles per liter
Standard Deviation 0.1189
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 12, Week 24, n=85
|
0.0220 millimoles per liter
Standard Deviation 0.1251
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 12, Week 32, n=84
|
0.0009 millimoles per liter
Standard Deviation 0.1265
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 12, Week 40, n=82
|
-0.0103 millimoles per liter
Standard Deviation 0.1247
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 12, Week 48, n=72
|
-0.0028 millimoles per liter
Standard Deviation 0.1206
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 13, Week 8, n=53
|
-0.0151 millimoles per liter
Standard Deviation 0.1402
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 13, Week 16, n=42
|
-0.0154 millimoles per liter
Standard Deviation 0.1595
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 13, Week 24, n=20
|
0.0037 millimoles per liter
Standard Deviation 0.1435
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 13, Week 32, n=7
|
-0.0784 millimoles per liter
Standard Deviation 0.1234
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Year 13, Week 40, n=1
|
0.0000 millimoles per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, Exit, n=248
|
0.0141 millimoles per liter
Standard Deviation 0.1239
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, 8-Week Follow-up, n=220
|
0.0082 millimoles per liter
Standard Deviation 0.1152
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Calcium, 24-Week Follow-up , n=200
|
0.0181 millimoles per liter
Standard Deviation 0.1211
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 1, Week 8, n=281
|
0.2 millimoles per liter
Standard Deviation 2.54
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 1, Week 16, n=283
|
0.7 millimoles per liter
Standard Deviation 2.73
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 1, Week 24, n=287
|
0.9 millimoles per liter
Standard Deviation 2.78
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 1, Week 32, n=283
|
1.0 millimoles per liter
Standard Deviation 2.51
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 1, Week 40, n=282
|
1.0 millimoles per liter
Standard Deviation 2.75
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 1, Week 48, n=284
|
1.3 millimoles per liter
Standard Deviation 2.71
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 2, Week 8, n=288
|
1.0 millimoles per liter
Standard Deviation 2.74
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 2, Week 16, n=275
|
1.2 millimoles per liter
Standard Deviation 2.74
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 2, Week 24, n=269
|
1.2 millimoles per liter
Standard Deviation 2.96
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 2, Week 32, n=284
|
1.3 millimoles per liter
Standard Deviation 2.77
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 2, Week 40, n=261
|
1.1 millimoles per liter
Standard Deviation 2.72
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 2, Week 48, n=267
|
1.7 millimoles per liter
Standard Deviation 3.02
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 3, Week 8, n=262
|
1.3 millimoles per liter
Standard Deviation 2.83
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 3, Week 16, n=258
|
1.5 millimoles per liter
Standard Deviation 2.95
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 3, Week 24, n=241
|
1.0 millimoles per liter
Standard Deviation 2.81
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 3, Week 32, n=245
|
1.1 millimoles per liter
Standard Deviation 2.96
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 3, Week 40, n=242
|
1.0 millimoles per liter
Standard Deviation 2.94
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 3, Week 48, n=239
|
1.3 millimoles per liter
Standard Deviation 3.29
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 4, Week 8, n=237
|
1.1 millimoles per liter
Standard Deviation 2.81
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 4, Week 16, n=235
|
1.3 millimoles per liter
Standard Deviation 3.04
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 4, Week 24, n=225
|
1.0 millimoles per liter
Standard Deviation 2.84
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 4, Week 32, n=230
|
1.1 millimoles per liter
Standard Deviation 2.90
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 4, Week 40, n=218
|
1.2 millimoles per liter
Standard Deviation 3.11
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 4, Week 48, n=214
|
1.6 millimoles per liter
Standard Deviation 3.17
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 5, Week 8, n=217
|
1.4 millimoles per liter
Standard Deviation 2.93
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 5, Week 16, n=213
|
1.7 millimoles per liter
Standard Deviation 2.93
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 5, Week 24, n=206
|
1.4 millimoles per liter
Standard Deviation 2.82
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 5, Week 32, n=211
|
1.5 millimoles per liter
Standard Deviation 2.98
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 5, Week 40, n=196
|
1.5 millimoles per liter
Standard Deviation 2.91
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 5, Week 48, n=207
|
1.7 millimoles per liter
Standard Deviation 2.82
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 6, Week 8, n=205
|
1.8 millimoles per liter
Standard Deviation 3.10
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 6, Week 16, n=198
|
1.8 millimoles per liter
Standard Deviation 2.94
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 6, Week 24, n=189
|
1.7 millimoles per liter
Standard Deviation 2.77
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 6, Week 32, n=192
|
1.7 millimoles per liter
Standard Deviation 2.82
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 6, Week 40, n=181
|
1.8 millimoles per liter
Standard Deviation 3.07
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 6, Week 48, n=186
|
1.9 millimoles per liter
Standard Deviation 2.97
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 7, Week 8, n=177
|
1.8 millimoles per liter
Standard Deviation 3.12
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 7, Week 16, n=178
|
1.6 millimoles per liter
Standard Deviation 3.11
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 7, Week 24, n=171
|
1.6 millimoles per liter
Standard Deviation 3.08
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 7, Week 32, n=179
|
1.6 millimoles per liter
Standard Deviation 3.10
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 7, Week 40, n=172
|
1.6 millimoles per liter
Standard Deviation 2.83
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 7, Week 48, n=175
|
1.6 millimoles per liter
Standard Deviation 2.97
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 8, Week 8, n=170
|
1.5 millimoles per liter
Standard Deviation 3.00
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 8, Week 16, n=169
|
1.5 millimoles per liter
Standard Deviation 3.17
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 8, Week 24, n=167
|
1.5 millimoles per liter
Standard Deviation 3.08
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 8, Week 32, n=166
|
1.5 millimoles per liter
Standard Deviation 3.27
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 8, Week 40, n=161
|
1.6 millimoles per liter
Standard Deviation 3.32
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 8, Week 48, n=159
|
1.5 millimoles per liter
Standard Deviation 3.25
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 9, Week 8, n=163
|
1.1 millimoles per liter
Standard Deviation 3.26
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 9, Week 16, n=160
|
1.4 millimoles per liter
Standard Deviation 3.08
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 9, Week 24, n=160
|
1.1 millimoles per liter
Standard Deviation 2.93
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 9, Week 32, n=162
|
1.4 millimoles per liter
Standard Deviation 3.13
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 9, Week 40, n=156
|
1.0 millimoles per liter
Standard Deviation 3.30
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 9, Week 48, n=150
|
1.0 millimoles per liter
Standard Deviation 3.16
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 10, Week 8, n=151
|
1.1 millimoles per liter
Standard Deviation 2.95
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 10, Week 16, n=143
|
1.2 millimoles per liter
Standard Deviation 3.14
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 10, Week 24, n=145
|
1.0 millimoles per liter
Standard Deviation 3.14
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 10, Week 24, n=145
|
-0.3 millimoles per liter
Standard Deviation 3.87
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 10, Week 32, n=142
|
-0.3 millimoles per liter
Standard Deviation 3.72
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 10, Week 40, n=138
|
-0.2 millimoles per liter
Standard Deviation 3.18
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 10, Week 48, n=135
|
-0.2 millimoles per liter
Standard Deviation 3.48
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 11, Week 8, n=138
|
-0.1 millimoles per liter
Standard Deviation 3.28
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 11, Week 16, n=128
|
-0.4 millimoles per liter
Standard Deviation 3.41
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 11, Week 24, n=130
|
-0.5 millimoles per liter
Standard Deviation 3.39
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 11, Week 32, n=125
|
-0.7 millimoles per liter
Standard Deviation 3.69
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 11, Week 40, n=124
|
-0.4 millimoles per liter
Standard Deviation 3.22
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 11, Week 48, n=108
|
-0.4 millimoles per liter
Standard Deviation 3.33
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 12, Week 8, n=110
|
-0.3 millimoles per liter
Standard Deviation 3.51
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 12, Week 16, n=97
|
-0.6 millimoles per liter
Standard Deviation 3.23
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 12, Week 24, n=87
|
-0.3 millimoles per liter
Standard Deviation 3.18
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 12, Week 32, n=84
|
-0.4 millimoles per liter
Standard Deviation 3.01
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 12, Week 40, n=82
|
-0.4 millimoles per liter
Standard Deviation 3.32
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 12, Week 48, n=72
|
-1.3 millimoles per liter
Standard Deviation 3.09
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 13, Week 8, n=53
|
-0.8 millimoles per liter
Standard Deviation 3.31
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 13, Week 16, n=42
|
-0.8 millimoles per liter
Standard Deviation 3.00
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 13, Week 24, n=20
|
0.0 millimoles per liter
Standard Deviation 3.03
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 13, Week 32, n=7
|
1.1 millimoles per liter
Standard Deviation 3.13
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 13, Week 40, n=1
|
0.0 millimoles per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Exit, n=248
|
-0.8 millimoles per liter
Standard Deviation 3.38
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, 8-Week Follow-up, n=220
|
-0.8 millimoles per liter
Standard Deviation 3.33
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, 24-Week Follow-up, n=200
|
-0.8 millimoles per liter
Standard Deviation 3.52
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 1, Week 8, n=284
|
-0.003 millimoles per liter
Standard Deviation 0.0646
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 1, Week 16, n=286
|
-0.006 millimoles per liter
Standard Deviation 0.0707
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 1, Week 24, n=292
|
-0.002 millimoles per liter
Standard Deviation 0.0660
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 1, Week 32, n=287
|
-0.007 millimoles per liter
Standard Deviation 0.0680
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 1, Week 40, n=284
|
-0.007 millimoles per liter
Standard Deviation 0.0657
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 1, Week 48, n=287
|
-0.017 millimoles per liter
Standard Deviation 0.0724
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 2, Week 8, n=288
|
-0.016 millimoles per liter
Standard Deviation 0.0694
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 2, Week 16, n=278
|
-0.015 millimoles per liter
Standard Deviation 0.0723
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 2, Week 24, n=273
|
-0.020 millimoles per liter
Standard Deviation 0.0704
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 2, Week 32, n=284
|
-0.018 millimoles per liter
Standard Deviation 0.0642
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 2, Week 40, n=264
|
-0.018 millimoles per liter
Standard Deviation 0.0699
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 2, Week 48, n=269
|
-0.021 millimoles per liter
Standard Deviation 0.0720
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 3, Week 8, n=265
|
-0.029 millimoles per liter
Standard Deviation 0.0709
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 3, Week 16, n=260
|
-0.027 millimoles per liter
Standard Deviation 0.0672
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 3, Week 24, n=244
|
-0.040 millimoles per liter
Standard Deviation 0.0646
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 3, Week 32, n=249
|
-0.042 millimoles per liter
Standard Deviation 0.0742
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 3, Week 40, n=245
|
-0.054 millimoles per liter
Standard Deviation 0.0712
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 3, Week 48, n=244
|
-0.051 millimoles per liter
Standard Deviation 0.0724
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 4, Week 8, n=239
|
-0.052 millimoles per liter
Standard Deviation 0.0692
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 4, Week 16, n=238
|
-0.049 millimoles per liter
Standard Deviation 0.0764
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 4, Week 24, n=227
|
-0.046 millimoles per liter
Standard Deviation 0.0720
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 4, Week 32, n=233
|
-0.049 millimoles per liter
Standard Deviation 0.0709
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 4, Week 40, n=220
|
-0.053 millimoles per liter
Standard Deviation 0.0702
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 4, Week 48, n=218
|
-0.050 millimoles per liter
Standard Deviation 0.0757
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 5, Week 8, n=218
|
-0.052 millimoles per liter
Standard Deviation 0.0676
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 5, Week 16, n=214
|
-0.054 millimoles per liter
Standard Deviation 0.0633
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 5, Week 24, n=211
|
-0.062 millimoles per liter
Standard Deviation 0.0648
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 5, Week 32, n=211
|
-0.068 millimoles per liter
Standard Deviation 0.0700
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 5, Week 40, n=198
|
-0.063 millimoles per liter
Standard Deviation 0.0709
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 5, Week 48, n=207
|
-0.067 millimoles per liter
Standard Deviation 0.0754
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 6, Week 8, n=206
|
-0.059 millimoles per liter
Standard Deviation 0.0724
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 6, Week 16, n=198
|
-0.067 millimoles per liter
Standard Deviation 0.0786
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 6, Week 24, n=190
|
-0.065 millimoles per liter
Standard Deviation 0.0724
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 6, Week 32, n=193
|
-0.063 millimoles per liter
Standard Deviation 0.0712
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 6, Week 40, n=185
|
-0.060 millimoles per liter
Standard Deviation 0.0750
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 6, Week 48, n=186
|
-0.068 millimoles per liter
Standard Deviation 0.0721
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 7, Week 8, n=179
|
-0.052 millimoles per liter
Standard Deviation 0.0746
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 7, Week 16, n=179
|
-0.058 millimoles per liter
Standard Deviation 0.0711
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 7, Week 24, n=173
|
-0.056 millimoles per liter
Standard Deviation 0.0712
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 7, Week 32, n=180
|
-0.054 millimoles per liter
Standard Deviation 0.0747
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 7, Week 40, n=175
|
-0.050 millimoles per liter
Standard Deviation 0.0826
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 7, Week 48, n=175
|
-0.057 millimoles per liter
Standard Deviation 0.0772
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 8, Week 8, n=171
|
-0.052 millimoles per liter
Standard Deviation 0.0761
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 8, Week 16, n=170
|
-0.060 millimoles per liter
Standard Deviation 0.0748
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 8, Week 24, n=168
|
-0.051 millimoles per liter
Standard Deviation 0.0739
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 8, Week 32, n=168
|
-0.055 millimoles per liter
Standard Deviation 0.0777
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 8, Week 40, n=162
|
-0.050 millimoles per liter
Standard Deviation 0.0737
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 8, Week 48, n=159
|
-0.047 millimoles per liter
Standard Deviation 0.0788
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 9, Week 8, n=164
|
-0.049 millimoles per liter
Standard Deviation 0.0793
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 9, Week 16, n=162
|
-0.047 millimoles per liter
Standard Deviation 0.0776
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 9, Week 24, n=161
|
-0.052 millimoles per liter
Standard Deviation 0.0825
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 9, Week 32, n=163
|
-0.052 millimoles per liter
Standard Deviation 0.0771
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 9, Week 40, n=156
|
-0.048 millimoles per liter
Standard Deviation 0.0840
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 9, Week 48, n=151
|
-0.056 millimoles per liter
Standard Deviation 0.0771
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 10, Week 8, n=152
|
-0.050 millimoles per liter
Standard Deviation 0.0795
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 10, Week 16, n=143
|
-0.054 millimoles per liter
Standard Deviation 0.0772
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 10, Week 24, n=145
|
-0.055 millimoles per liter
Standard Deviation 0.0770
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 10, Week 32, n=142
|
-0.050 millimoles per liter
Standard Deviation 0.0750
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 10, Week 40, n=138
|
-0.055 millimoles per liter
Standard Deviation 0.0798
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 10, Week 48, n=135
|
-0.055 millimoles per liter
Standard Deviation 0.0825
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 11, Week 8, n=138
|
-0.057 millimoles per liter
Standard Deviation 0.0823
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 11, Week 16, n=128
|
-0.055 millimoles per liter
Standard Deviation 0.0809
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 11, Week 24, n=130
|
-0.055 millimoles per liter
Standard Deviation 0.0810
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 11, Week 32, n=125
|
-0.055 millimoles per liter
Standard Deviation 0.0889
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 11, Week 40, n=124
|
-0.044 millimoles per liter
Standard Deviation 0.0842
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 11, Week 48, n=108
|
-0.057 millimoles per liter
Standard Deviation 0.0800
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 12, Week 8, n=110
|
-0.041 millimoles per liter
Standard Deviation 0.0855
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 12, Week 16, n=97
|
-0.047 millimoles per liter
Standard Deviation 0.0797
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 12, Week 24, n=87
|
-0.040 millimoles per liter
Standard Deviation 0.0846
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 12, Week 32, n=84
|
-0.056 millimoles per liter
Standard Deviation 0.0808
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 12, Week 40, n=82
|
-0.049 millimoles per liter
Standard Deviation 0.0909
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 12, Week 48, n=72
|
-0.047 millimoles per liter
Standard Deviation 0.0809
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 13, Week 8, n=53
|
-0.045 millimoles per liter
Standard Deviation 0.0834
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 13, Week 16, n=42
|
-0.046 millimoles per liter
Standard Deviation 0.0752
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 13, Week 24, n=20
|
-0.055 millimoles per liter
Standard Deviation 0.0776
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 13, Week 32, n=7
|
-0.050 millimoles per liter
Standard Deviation 0.0500
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Year 13, Week 40, n=1
|
0.050 millimoles per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, Exit, n=248
|
-0.037 millimoles per liter
Standard Deviation 0.0793
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, 8-Week Follow-up, n=220
|
-0.037 millimoles per liter
Standard Deviation 0.0794
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Magnesium, 24-Week Follow-up , n=200
|
-0.040 millimoles per liter
Standard Deviation 0.0790
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 1, Week 8, n=284
|
-0.0259 millimoles per liter
Standard Deviation 0.1980
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 1, Week 16, n=286
|
-0.0215 millimoles per liter
Standard Deviation 0.1849
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 1, Week 24, n=292
|
-0.0001 millimoles per liter
Standard Deviation 0.2023
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 1, Week 32, n=287
|
-0.0154 millimoles per liter
Standard Deviation 0.1983
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 1, Week 40, n=284
|
-0.0024 millimoles per liter
Standard Deviation 0.1913
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 1, Week 48, n=287
|
-0.0234 millimoles per liter
Standard Deviation 0.1926
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 2, Week 8, n=288
|
-0.0185 millimoles per liter
Standard Deviation 0.1959
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 2, Week 16, n=278
|
-0.0194 millimoles per liter
Standard Deviation 0.2003
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 2, Week 24, n=273
|
-0.0209 millimoles per liter
Standard Deviation 0.1991
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 2, Week 32, n=284
|
-0.0318 millimoles per liter
Standard Deviation 0.2122
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 2, Week 40, n=264
|
-0.0297 millimoles per liter
Standard Deviation 0.2103
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 2, Week 48, n=269
|
-0.0116 millimoles per liter
Standard Deviation 0.2050
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 3, Week 8, n=265
|
-0.04112 millimoles per liter
Standard Deviation 0.2073
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 3, Week 16, n=260
|
-0.0451 millimoles per liter
Standard Deviation 0.2059
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 3, Week 24, n=244
|
-0.0639 millimoles per liter
Standard Deviation 0.2068
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 3, Week 32, n=249
|
-0.0484 millimoles per liter
Standard Deviation 0.2139
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 3, Week 40, n=245
|
-0.0583 millimoles per liter
Standard Deviation 0.2190
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 3, Week 48, n=244
|
-0.0658 millimoles per liter
Standard Deviation 0.2179
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 4, Week 8, n=239
|
-0.0621 millimoles per liter
Standard Deviation 0.2103
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 4, Week 16, n=238
|
-0.0532 millimoles per liter
Standard Deviation 0.2217
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 4, Week 24, n=227
|
-0.0700 millimoles per liter
Standard Deviation 0.2106
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 4, Week 32, n=233
|
-0.0601 millimoles per liter
Standard Deviation 0.2034
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 4, Week 40, n=220
|
-0.0710 millimoles per liter
Standard Deviation 0.2098
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 4, Week 48, n=218
|
-0.0400 millimoles per liter
Standard Deviation 0.2213
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 5, Week 8, n=218
|
-0.0529 millimoles per liter
Standard Deviation 0.2222
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 5, Week 16, n=214
|
-0.0429 millimoles per liter
Standard Deviation 0.2240
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 5, Week 24, n=211
|
-0.0502 millimoles per liter
Standard Deviation 0.1996
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 5, Week 32, n=211
|
-0.0435 millimoles per liter
Standard Deviation 0.2313
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 5, Week 40, n=198
|
-0.0452 millimoles per liter
Standard Deviation 0.2147
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 5, Week 48, n=207
|
-0.0323 millimoles per liter
Standard Deviation 0.2167
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 6, Week 8, n=206
|
-0.0417 millimoles per liter
Standard Deviation 0.2246
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 6, Week 16, n=198
|
-0.0354 millimoles per liter
Standard Deviation 0.2253
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 6, Week 24, n=190
|
-0.0262 millimoles per liter
Standard Deviation 0.2326
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 6, Week 32, n=193
|
-0.0341 millimoles per liter
Standard Deviation 0.2154
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 6, Week 40, n=185
|
-0.0086 millimoles per liter
Standard Deviation 0.2179
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 6, Week 48, n=186
|
-0.0085 millimoles per liter
Standard Deviation 0.2256
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 7, Week 8, n=179
|
-0.0316 millimoles per liter
Standard Deviation 0.2254
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 7, Week 16, n=179
|
-0.0372 millimoles per liter
Standard Deviation 0.1999
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 7, Week 24, n=173
|
-0.0390 millimoles per liter
Standard Deviation 0.2099
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 7, Week 32, n=180
|
-0.0321 millimoles per liter
Standard Deviation 0.2099
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 7, Week 40, n=175
|
-0.0138 millimoles per liter
Standard Deviation 0.2146
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 7, Week 48, n=175
|
-0.0400 millimoles per liter
Standard Deviation 0.2031
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 8, Week 8, n=171
|
-0.0453 millimoles per liter
Standard Deviation 0.2135
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 8, Week 16, n=170
|
-0.0319 millimoles per liter
Standard Deviation 0.2088
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 8, Week 24, n=168
|
-0.0450 millimoles per liter
Standard Deviation 0.2136
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 8, Week 32, n=168
|
-0.0530 millimoles per liter
Standard Deviation 0.2073
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 8, Week 40, n=162
|
-0.0429 millimoles per liter
Standard Deviation 0.2341
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 8, Week 48, n=159
|
-0.0266 millimoles per liter
Standard Deviation 0.2158
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 9, Week 8, n=164
|
-0.0329 millimoles per liter
Standard Deviation 0.2133
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 9, Week 16, n=162
|
-0.0255 millimoles per liter
Standard Deviation 0.2140
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 9, Week 24, n=161
|
-0.0327 millimoles per liter
Standard Deviation 0.2372
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 9, Week 32, n=163
|
-0.0487 millimoles per liter
Standard Deviation 0.2039
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 9, Week 40, n=156
|
-0.0230 millimoles per liter
Standard Deviation 0.2123
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 9, Week 48, n=151
|
-0.0385 millimoles per liter
Standard Deviation 0.2170
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 10, Week 8, n=152
|
-0.0310 millimoles per liter
Standard Deviation 0.2136
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 10, Week 16, n=143
|
-0.0458 millimoles per liter
Standard Deviation 0.2087
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 10, Week 24, n=145
|
-0.0307 millimoles per liter
Standard Deviation 0.2130
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 10, Week 32, n=142
|
-0.0241 millimoles per liter
Standard Deviation 0.2227
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 10, Week 40, n=138
|
-0.0459 millimoles per liter
Standard Deviation 0.2184
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 10, Week 48, n=135
|
-0.0335 millimoles per liter
Standard Deviation 0.2158
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 11, Week 8, n=138
|
-0.0314 millimoles per liter
Standard Deviation 0.2311
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 11, Week 16, n=128
|
-0.0560 millimoles per liter
Standard Deviation 0.2327
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 11, Week 24, n=130
|
-0.0365 millimoles per liter
Standard Deviation 0.2371
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 11, Week 32, n=125
|
-0.0302 millimoles per liter
Standard Deviation 0.2140
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 11, Week 40, n=124
|
-0.0370 millimoles per liter
Standard Deviation 0.2215
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 11, Week 48, n=108
|
-0.0287 millimoles per liter
Standard Deviation 0.2361
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 12, Week 8, n=110
|
-0.0470 millimoles per liter
Standard Deviation 0.2230
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 12, Week 16, n=97
|
-0.0333 millimoles per liter
Standard Deviation 0.2264
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 12, Week 24, n=87
|
-0.0238 millimoles per liter
Standard Deviation 0.2169
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 12, Week 32, n=84
|
-0.0488 millimoles per liter
Standard Deviation 0.2235
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 12, Week 40, n=82
|
-0.0555 millimoles per liter
Standard Deviation 0.2188
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 12, Week 48, n=72
|
-0.0341 millimoles per liter
Standard Deviation 0.2213
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 13, Week 8, n=53
|
-0.0804 millimoles per liter
Standard Deviation 0.2002
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 13, Week 16, n=42
|
-0.0461 millimoles per liter
Standard Deviation 0.2669
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 13, Week 24, n=20
|
0.0533 millimoles per liter
Standard Deviation 0.1881
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 13, Week 32, n=7
|
0.0784 millimoles per liter
Standard Deviation 0.2075
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Year 13, Week 40, n=1
|
-0.1615 millimoles per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, Exit, n=248
|
-0.0328 millimoles per liter
Standard Deviation 0.2385
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, 8-Week Follow-up, n=220
|
-0.0631 millimoles per liter
Standard Deviation 0.2221
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Phosphate, 24-Week Follow-up , n=200
|
-0.0375 millimoles per liter
Standard Deviation 0.2183
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 1, Week 8, n=281
|
-0.01 millimoles per liter
Standard Deviation 0.354
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 1, Week 16, n=283
|
0.04 millimoles per liter
Standard Deviation 0.394
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 1, Week 24, n=287
|
0.04 millimoles per liter
Standard Deviation 0.406
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 1, Week 32, n=283
|
0.01 millimoles per liter
Standard Deviation 0.381
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 1, Week 40, n=282
|
0.03 millimoles per liter
Standard Deviation 0.378
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 1, Week 48, n=284
|
0.00 millimoles per liter
Standard Deviation 0.406
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 2, Week 8, n=288
|
0.00 millimoles per liter
Standard Deviation 0.370
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 2, Week 16, n=275
|
0.03 millimoles per liter
Standard Deviation 0.385
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 2, Week 24, n=269
|
0.02 millimoles per liter
Standard Deviation 0.398
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 2, Week 32, n=284
|
0.00 millimoles per liter
Standard Deviation 0.397
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 2, Week 40, n=261
|
0.04 millimoles per liter
Standard Deviation 0.378
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 2, Week 48, n=267
|
0.01 millimoles per liter
Standard Deviation 0.386
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 3, Week 8, n=262
|
0.00 millimoles per liter
Standard Deviation 0.415
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 3, Week 16, n=258
|
0.02 millimoles per liter
Standard Deviation 0.413
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 3, Week 24, n=241
|
0.02 millimoles per liter
Standard Deviation 0.407
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 3, Week 32, n=245
|
-0.02 millimoles per liter
Standard Deviation 0.406
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 3, Week 40, n=242
|
0.02 millimoles per liter
Standard Deviation 0.428
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 3, Week 48, n=239
|
0.00 millimoles per liter
Standard Deviation 0.400
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 4, Week 8, n=237
|
0.03 millimoles per liter
Standard Deviation 0.414
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 4, Week 16, n=236
|
0.00 millimoles per liter
Standard Deviation 0.423
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 4, Week 24, n=225
|
0.03 millimoles per liter
Standard Deviation 0.400
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 4, Week 32, n=230
|
0.02 millimoles per liter
Standard Deviation 0.383
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 4, Week 40, n=218
|
-0.02 millimoles per liter
Standard Deviation 0.396
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 4, Week 48, n=214
|
0.02 millimoles per liter
Standard Deviation 0.391
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 5, Week 8, n=217
|
0.01 millimoles per liter
Standard Deviation 0.413
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 5, Week 16, n=213
|
0.00 millimoles per liter
Standard Deviation 0.390
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 5, Week 24, n=206
|
0.03 millimoles per liter
Standard Deviation 0.420
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 5, Week 32, n=211
|
-0.01 millimoles per liter
Standard Deviation 0.393
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 5, Week 40, n=196
|
0.03 millimoles per liter
Standard Deviation 0.416
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 5, Week 48, n=207
|
-0.01 millimoles per liter
Standard Deviation 0.375
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 6, Week 8, n=205
|
-0.02 millimoles per liter
Standard Deviation 0.424
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 6, Week 16, n=198
|
-0.04 millimoles per liter
Standard Deviation 0.429
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 6, Week 24, n=189
|
0.00 millimoles per liter
Standard Deviation 0.411
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 6, Week 32, n=192
|
-0.02 millimoles per liter
Standard Deviation 0.395
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 6, Week 40, n=181
|
0.03 millimoles per liter
Standard Deviation 0.435
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 6, Week 48, n=186
|
-0.01 millimoles per liter
Standard Deviation 0.388
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium,Year 7, Week 8, n=177
|
0.00 millimoles per liter
Standard Deviation 0.424
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 7, Week 16, n=178
|
-0.02 millimoles per liter
Standard Deviation 0.412
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 7, Week 24, n=171
|
0.03 millimoles per liter
Standard Deviation 0.388
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 7, Week 32, n=179
|
0.02 millimoles per liter
Standard Deviation 0.406
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 7, Week 40, n=172
|
0.03 millimoles per liter
Standard Deviation 0.453
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 7, Week 48, n=175
|
-0.03 millimoles per liter
Standard Deviation 0.403
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 8, Week 8, n=170
|
-0.05 millimoles per liter
Standard Deviation 0.426
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 8, Week 16, n=169
|
-0.05 millimoles per liter
Standard Deviation 0.455
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 8, Week 24, n=167
|
0.00 millimoles per liter
Standard Deviation 0.386
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 8, Week 32, n=166
|
-0.06 millimoles per liter
Standard Deviation 0.382
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 8, Week 40, n=161
|
0.00 millimoles per liter
Standard Deviation 0.401
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 8, Week 48, n=159
|
-0.07 millimoles per liter
Standard Deviation 0.377
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 9, Week 8, n=163
|
-0.02 millimoles per liter
Standard Deviation 0.448
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 9, Week 16, n=160
|
-0.02 millimoles per liter
Standard Deviation 0.385
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 9, Week 24, n=160
|
-0.03 millimoles per liter
Standard Deviation 0.391
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 9, Week 32, n=162
|
-0.05 millimoles per liter
Standard Deviation 0.391
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 9, Week 40, n=156
|
-0.04 millimoles per liter
Standard Deviation 0.447
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 9, Week 48, n=150
|
-0.04 millimoles per liter
Standard Deviation 0.432
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 10, Week 8, n=151
|
-0.03 millimoles per liter
Standard Deviation 0.417
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 10, Week 16, n=143
|
-0.05 millimoles per liter
Standard Deviation 0.415
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 10, Week 24, n=145
|
0.00 millimoles per liter
Standard Deviation 0.428
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 10, Week 32, n=140
|
-0.03 millimoles per liter
Standard Deviation 0.452
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 10, Week 40, n=137
|
-0.02 millimoles per liter
Standard Deviation 0.433
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 10, Week 48, n=135
|
-0.02 millimoles per liter
Standard Deviation 0.442
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 11, Week 8, n=138
|
-0.03 millimoles per liter
Standard Deviation 0.438
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 11, Week 16, n=128
|
-0.04 millimoles per liter
Standard Deviation 0.395
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 11, Week 24, n=129
|
0.02 millimoles per liter
Standard Deviation 0.433
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 11, Week 32, n=124
|
-0.08 millimoles per liter
Standard Deviation 0.399
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 11, Week 40, n=124
|
-0.01 millimoles per liter
Standard Deviation 0.383
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 11, Week 48, n=107
|
0.01 millimoles per liter
Standard Deviation 0.413
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 12, Week 8, n=109
|
0.01 millimoles per liter
Standard Deviation 0.422
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 12, Week 16, n=97
|
-0.02 millimoles per liter
Standard Deviation 0.433
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 12, Week 24, n=85
|
0.00 millimoles per liter
Standard Deviation 0.447
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 12, Week 32, n=84
|
-0.06 millimoles per liter
Standard Deviation 0.443
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 12, Week 40, n=82
|
-0.02 millimoles per liter
Standard Deviation 0.411
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 12, Week 48, n=72
|
-0.06 millimoles per liter
Standard Deviation 0.527
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 13, Week 8, n=53
|
-0.14 millimoles per liter
Standard Deviation 0.401
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 13, Week 16, n=42
|
-0.09 millimoles per liter
Standard Deviation 0.416
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 13, Week 24, n=20
|
0.01 millimoles per liter
Standard Deviation 0.525
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 13, Week 32, n=7
|
-0.19 millimoles per liter
Standard Deviation 0.389
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Year 13, Week 40, n=1
|
0.60 millimoles per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, Exit, n=248
|
0.03 millimoles per liter
Standard Deviation 0.409
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, 8-Week Follow-up, n=220
|
0.01 millimoles per liter
Standard Deviation 0.415
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Potassium, 24-Week Follow-up , n=200
|
0.02 millimoles per liter
Standard Deviation 0.411
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 1, Week 8, n=284
|
0.1 millimoles per liter
Standard Deviation 2.76
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 1, Week 16, n=286
|
0.2 millimoles per liter
Standard Deviation 2.91
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, ,Year 1, Week 24, n=292
|
0.0 millimoles per liter
Standard Deviation 2.78
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 1, Week 32, n=287
|
0.0 millimoles per liter
Standard Deviation 2.83
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 1, Week 40, n=284
|
-0.2 millimoles per liter
Standard Deviation 2.64
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 1, Week 48, n=287
|
-0.1 millimoles per liter
Standard Deviation 2.75
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 2, Week 8, n=288
|
0.0 millimoles per liter
Standard Deviation 2.64
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 2, Week 16, n=278
|
0.1 millimoles per liter
Standard Deviation 2.74
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 2, Week 24, n=273
|
0.1 millimoles per liter
Standard Deviation 2.72
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 2, Week 32, n=284
|
-0.3 millimoles per liter
Standard Deviation 2.79
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 2, Week 40, n=264
|
-0.2 millimoles per liter
Standard Deviation 2.67
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 2, Week 48, n=269
|
-0.1 millimoles per liter
Standard Deviation 2.86
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 3, Week 8, n=265
|
-0.3 millimoles per liter
Standard Deviation 2.81
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 3, Week 16, n=260
|
-0.3 millimoles per liter
Standard Deviation 2.90
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 3, Week 24, n=244
|
-0.2 millimoles per liter
Standard Deviation 2.76
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 3, Week 32, n=249
|
-0.2 millimoles per liter
Standard Deviation 2.74
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 3, Week 40, n=245
|
-0.2 millimoles per liter
Standard Deviation 2.77
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 3, Week 48, n=244
|
-0.3 millimoles per liter
Standard Deviation 2.91
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 4, Week 8, n=239
|
-0.2 millimoles per liter
Standard Deviation 2.72
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 4, Week 16, n=238
|
-0.2 millimoles per liter
Standard Deviation 2.71
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 4, Week 24, n=227
|
-0.1 millimoles per liter
Standard Deviation 2.64
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 4, Week 32, n=233
|
-0.2 millimoles per liter
Standard Deviation 2.57
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 4, Week 40, n=220
|
-0.1 millimoles per liter
Standard Deviation 2.55
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 4, Week 48, n=218
|
-0.1 millimoles per liter
Standard Deviation 2.64
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 5, Week 8, n=218
|
-0.1 millimoles per liter
Standard Deviation 2.85
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 5, Week 16, n=214
|
-0.1 millimoles per liter
Standard Deviation 2.60
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 5, Week 24, n=211
|
0.0 millimoles per liter
Standard Deviation 2.92
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 5, Week 32, n=211
|
-0.1 millimoles per liter
Standard Deviation 2.74
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 5, Week 40, n=198
|
0.1 millimoles per liter
Standard Deviation 3.04
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 5, Week 48, n=207
|
-0.3 millimoles per liter
Standard Deviation 2.90
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 6, Week 8, n=206
|
-0.1 millimoles per liter
Standard Deviation 2.96
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 6, Week 16, n=198
|
-0.3 millimoles per liter
Standard Deviation 2.85
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 6, Week 24, n=190
|
-0.3 millimoles per liter
Standard Deviation 2.90
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 6, Week 32, n=193
|
-0.3 millimoles per liter
Standard Deviation 2.90
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 6, Week 40, n=185
|
-0.3 millimoles per liter
Standard Deviation 2.91
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 6, Week 48, n=186
|
-0.4 millimoles per liter
Standard Deviation 2.77
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium,Year 7, Week 8, n=179
|
-0.4 millimoles per liter
Standard Deviation 2.90
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 7, Week 16, n=179
|
-0.5 millimoles per liter
Standard Deviation 2.86
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 7, Week 24, n=173
|
-0.5 millimoles per liter
Standard Deviation 2.86
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 7, Week 32, n=180
|
-0.4 millimoles per liter
Standard Deviation 4.24
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 7, Week 40, n=175
|
-0.2 millimoles per liter
Standard Deviation 2.98
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 7, Week 48, n=175
|
-0.5 millimoles per liter
Standard Deviation 3.01
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 8, Week 8, n=171
|
-0.2 millimoles per liter
Standard Deviation 2.96
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 8, Week 16, n=170
|
-0.3 millimoles per liter
Standard Deviation 3.22
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 8, Week 24, n=168
|
-0.3 millimoles per liter
Standard Deviation 2.79
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 8, Week 32, n=168
|
-0.5 millimoles per liter
Standard Deviation 3.01
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 8, Week 40, n=162
|
-0.3 millimoles per liter
Standard Deviation 2.94
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 8, Week 48, n=159
|
-0.3 millimoles per liter
Standard Deviation 2.88
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 9, Week 8, n=164
|
-0.4 millimoles per liter
Standard Deviation 2.94
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 9, Week 16, n=162
|
-0.4 millimoles per liter
Standard Deviation 3.14
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 9, Week 24, n=161
|
-0.3 millimoles per liter
Standard Deviation 3.05
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 9, Week 32, n=163
|
-0.7 millimoles per liter
Standard Deviation 2.94
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 9, Week 40, n=156
|
-0.4 millimoles per liter
Standard Deviation 3.13
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 9, Week 48, n=151
|
-0.6 millimoles per liter
Standard Deviation 3.22
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 10, Week 8, n=152
|
-0.5 millimoles per liter
Standard Deviation 3.25
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 10, Week 16, n=143
|
-0.3 millimoles per liter
Standard Deviation 3.31
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 10, Week 24, n=145
|
-0.4 millimoles per liter
Standard Deviation 3.56
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 10, Week 32, n=142
|
-0.2 millimoles per liter
Standard Deviation 3.15
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 10, Week 40, n=138
|
-0.1 millimoles per liter
Standard Deviation 2.80
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 10, Week 48, n=135
|
-0.4 millimoles per liter
Standard Deviation 3.26
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 11, Week 8, n=138
|
-0.2 millimoles per liter
Standard Deviation 3.21
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 11, Week 16, n=128
|
-0.5 millimoles per liter
Standard Deviation 3.30
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 11, Week 24, n=130
|
-0.4 millimoles per liter
Standard Deviation 3.27
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 11, Week 32, n=125
|
-0.6 millimoles per liter
Standard Deviation 3.19
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 11, Week 40, n=124
|
-0.5 millimoles per liter
Standard Deviation 3.25
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 11, Week 48, n=108
|
-0.7 millimoles per liter
Standard Deviation 3.16
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 12, Week 8, n=110
|
-0.9 millimoles per liter
Standard Deviation 3.07
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 12, Week 16, n=97
|
-0.7 millimoles per liter
Standard Deviation 3.12
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 12, Week 24, n=87
|
-0.1 millimoles per liter
Standard Deviation 3.26
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 12, Week 32, n=84
|
-0.3 millimoles per liter
Standard Deviation 2.91
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 12, Week 40, n=82
|
-0.5 millimoles per liter
Standard Deviation 3.18
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 12, Week 48, n=72
|
-1.1 millimoles per liter
Standard Deviation 2.98
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 13, Week 8, n=53
|
-0.3 millimoles per liter
Standard Deviation 3.04
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 13, Week 16, n=42
|
-0.3 millimoles per liter
Standard Deviation 2.68
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 13, Week 24, n=20
|
0.2 millimoles per liter
Standard Deviation 3.47
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 13, Week 32, n=7
|
0.0 millimoles per liter
Standard Deviation 3.21
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Year 13, Week 40, n=1
|
2.0 millimoles per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, Exit, n=248
|
-0.7 millimoles per liter
Standard Deviation 2.96
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, 8-Week Follow-up, n=220
|
-0.5 millimoles per liter
Standard Deviation 3.06
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Sodium, 24-Week Follow-up , n=200
|
-0.3 millimoles per liter
Standard Deviation 3.16
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 6, Week 24, n=190
|
-0.2 millimoles per liter
Standard Deviation 3.11
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 6, Week 32, n=193
|
-0.4 millimoles per liter
Standard Deviation 3.31
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 6, Week 40, n=185
|
-0.3 millimoles per liter
Standard Deviation 3.25
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 6, Week 48, n=186
|
-0.4 millimoles per liter
Standard Deviation 3.07
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 7, Week 8, n=179
|
-0.3 millimoles per liter
Standard Deviation 2.95
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 7, Week 16, n=179
|
-0.3 millimoles per liter
Standard Deviation 3.10
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 7, Week 24, n=173
|
-0.2 millimoles per liter
Standard Deviation 3.18
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 10, Week 32, n=140
|
1.5 millimoles per liter
Standard Deviation 3.12
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 10, Week 40, n=137
|
1.5 millimoles per liter
Standard Deviation 3.21
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 10, Week 48, n=135
|
1.3 millimoles per liter
Standard Deviation 3.03
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 11, Week 8, n=138
|
1.0 millimoles per liter
Standard Deviation 3.13
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 11, Week 16, n=128
|
1.5 millimoles per liter
Standard Deviation 3.04
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 11, Week 24, n=129
|
1.5 millimoles per liter
Standard Deviation 3.13
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 11, Week 32, n=124
|
1.6 millimoles per liter
Standard Deviation 2.99
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 11, Week 40, n=124
|
1.7 millimoles per liter
Standard Deviation 3.03
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 11, Week 48, n=107
|
1.7 millimoles per liter
Standard Deviation 3.10
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 12, Week 8, n=109
|
1.1 millimoles per liter
Standard Deviation 3.12
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 12, Week 16, n=97
|
2.1 millimoles per liter
Standard Deviation 3.05
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 12, Week 24, n=85
|
2.0 millimoles per liter
Standard Deviation 3.12
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 12, Week 32, n=84
|
2.3 millimoles per liter
Standard Deviation 3.58
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 12, Week 40, n=82
|
2.0 millimoles per liter
Standard Deviation 3.26
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 12, Week 48, n=72
|
1.7 millimoles per liter
Standard Deviation 3.39
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 13, Week 8, n=53
|
1.6 millimoles per liter
Standard Deviation 2.90
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 13, Week 16, n=42
|
2.0 millimoles per liter
Standard Deviation 2.76
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 13, Week 24, n=20
|
2.5 millimoles per liter
Standard Deviation 3.19
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 13, Week 32, n=7
|
1.3 millimoles per liter
Standard Deviation 3.59
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Year 13, Week 40, n=1
|
4.0 millimoles per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, Exit, n=248
|
1.8 millimoles per liter
Standard Deviation 2.93
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, 8-Week Follow-up, n=220
|
1.8 millimoles per liter
Standard Deviation 3.26
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Carbon dioxide, 24-Week Follow-up , n=200
|
1.8 millimoles per liter
Standard Deviation 3.25
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 1, Week 8, n=284
|
0.1 millimoles per liter
Standard Deviation 2.52
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 1, Week 16, n=286
|
0.4 millimoles per liter
Standard Deviation 2.76
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 1, Week 24, n=292
|
0.0 millimoles per liter
Standard Deviation 2.64
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 1, Week 32, n=287
|
0.0 millimoles per liter
Standard Deviation 2.66
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 1, Week 40, n=284
|
0.0 millimoles per liter
Standard Deviation 2.74
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 1, Week 48, n=287
|
0.4 millimoles per liter
Standard Deviation 2.90
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 2, Week 8, n=288
|
0.2 millimoles per liter
Standard Deviation 2.77
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 2, Week 16, n=278
|
0.4 millimoles per liter
Standard Deviation 2.95
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 2, Week 24, n=273
|
0.6 millimoles per liter
Standard Deviation 2.82
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 2, Week 32, n=284
|
0.4 millimoles per liter
Standard Deviation 2.80
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 2, Week 40, n=264
|
0.3 millimoles per liter
Standard Deviation 3.05
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 2, Week 48, n=269
|
0.2 millimoles per liter
Standard Deviation 2.94
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 3, Week 8, n=265
|
0.3 millimoles per liter
Standard Deviation 3.07
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 3, Week 16, n=260
|
0.0 millimoles per liter
Standard Deviation 2.91
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 3, Week 24, n=244
|
0.1 millimoles per liter
Standard Deviation 2.93
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 3, Week 32, n=249
|
-0.1 millimoles per liter
Standard Deviation 2.99
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 3, Week 40, n=245
|
-0.2 millimoles per liter
Standard Deviation 2.87
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 3, Week 48, n=244
|
-0.3 millimoles per liter
Standard Deviation 3.29
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 4, Week 8, n=239
|
-0.2 millimoles per liter
Standard Deviation 2.93
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 4, Week 16, n=238
|
-0.2 millimoles per liter
Standard Deviation 3.16
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 4, Week 24, n=227
|
0.1 millimoles per liter
Standard Deviation 2.85
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 4, Week 32, n=233
|
-0.3 millimoles per liter
Standard Deviation 3.12
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 4, Week 40, n=220
|
-0.4 millimoles per liter
Standard Deviation 2.94
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 4, Week 48, n=218
|
-0.3 millimoles per liter
Standard Deviation 3.15
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 5, Week 8, n=218
|
-0.1 millimoles per liter
Standard Deviation 3.20
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 5, Week 16, n=214
|
0.1 millimoles per liter
Standard Deviation 2.80
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 7, Week 32, n=180
|
-0.3 millimoles per liter
Standard Deviation 4.06
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 7, Week 40, n=175
|
-0.4 millimoles per liter
Standard Deviation 3.32
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 7, Week 48, n=175
|
-0.4 millimoles per liter
Standard Deviation 3.24
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 8, Week 8, n=171
|
-0.3 millimoles per liter
Standard Deviation 3.46
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 8, Week 16, n=170
|
-0.5 millimoles per liter
Standard Deviation 3.75
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 8, Week 24, n=168
|
-0.5 millimoles per liter
Standard Deviation 3.37
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 8, Week 32, n=168
|
-0.6 millimoles per liter
Standard Deviation 3.30
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 8, Week 40, n=162
|
-0.4 millimoles per liter
Standard Deviation 3.26
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 8, Week 48, n=159
|
-0.4 millimoles per liter
Standard Deviation 3.49
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 9, Week 8, n=164
|
-0.7 millimoles per liter
Standard Deviation 3.36
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 9, Week 16, n=162
|
-0.7 millimoles per liter
Standard Deviation 3.26
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 9, Week 24, n=161
|
-0.3 millimoles per liter
Standard Deviation 3.21
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 9, Week 32, n=163
|
-0.6 millimoles per liter
Standard Deviation 3.43
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 9, Week 40, n=156
|
-0.3 millimoles per liter
Standard Deviation 3.72
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 9, Week 48, n=151
|
-0.6 millimoles per liter
Standard Deviation 3.76
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 10, Week 8, n=152
|
-0.6 millimoles per liter
Standard Deviation 3.61
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Chloride, Year 10, Week 16, n=143
|
-0.7 millimoles per liter
Standard Deviation 3.59
|
PRIMARY outcome
Timeframe: Baseline and approximately up to 13 yearsPopulation: MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in creatinine, urate, and bilirubin is summarized. The Baseline is defined as the Extension 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.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=296 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 1, Week 16, n=285
|
0.168 micromoles per liter
Standard Deviation 2.3476
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 1, Week 24, n=292
|
0.287 micromoles per liter
Standard Deviation 2.4529
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 1, Week 32, n=287
|
0.346 micromoles per liter
Standard Deviation 2.6100
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 1, Week 40, n=283
|
0.236 micromoles per liter
Standard Deviation 2.3829
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 1, Week 48, n=286
|
0.293 micromoles per liter
Standard Deviation 2.5315
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 2, Week 8, n=288
|
0.243 micromoles per liter
Standard Deviation 2.6498
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 2, Week 16, n=277
|
0.019 micromoles per liter
Standard Deviation 2.5896
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 2, Week 24, n=272
|
0.176 micromoles per liter
Standard Deviation 2.5041
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 1, Week 8, n=284
|
0.436 micromoles per liter
Standard Deviation 11.3838
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 1, Week 16, n=286
|
0.464 micromoles per liter
Standard Deviation 12.4820
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 1, Week 24, n=292
|
1.211 micromoles per liter
Standard Deviation 12.9503
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 1, Week 32, n=287
|
1.047 micromoles per liter
Standard Deviation 12.5885
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 1, Week 40, n=284
|
0.965 micromoles per liter
Standard Deviation 12.0245
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 1, Week 48, n=287
|
0.955 micromoles per liter
Standard Deviation 12.4760
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 2, Week 8, n=288
|
0.583 micromoles per liter
Standard Deviation 11.9874
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 2, Week 16, n=278
|
1.558 micromoles per liter
Standard Deviation 11.7857
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 2, Week 24, n=273
|
1.036 micromoles per liter
Standard Deviation 13.7310
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 2, Week 32, n=284
|
0.716 micromoles per liter
Standard Deviation 14.1894
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 2, Week 40, n=264
|
1.976 micromoles per liter
Standard Deviation 15.7590
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 2, Week 48, n=269
|
1.413 micromoles per liter
Standard Deviation 13.7896
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 3, Week 8, n=265
|
-1.268 micromoles per liter
Standard Deviation 14.8256
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 3, Week 16, n=260
|
-2.006 micromoles per liter
Standard Deviation 14.6735
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 3, Week 24, n=244
|
-2.464 micromoles per liter
Standard Deviation 15.3328
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 3, Week 32, n=249
|
-3.089 micromoles per liter
Standard Deviation 14.8793
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 3, Week 40, n=245
|
-3.320 micromoles per liter
Standard Deviation 18.5589
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 3, Week 48, n=244
|
-3.297 micromoles per liter
Standard Deviation 17.3222
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 4, Week 8, n=239
|
-3.440 micromoles per liter
Standard Deviation 14.6181
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 4, Week 16, n=238
|
-3.417 micromoles per liter
Standard Deviation 17.3832
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 4, Week 24, n=227
|
-3.271 micromoles per liter
Standard Deviation 15.7446
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 4, Week 32, n=233
|
-2.238 micromoles per liter
Standard Deviation 15.9372
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 4, Week 40, n=220
|
-2.331 micromoles per liter
Standard Deviation 15.0967
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 4, Week 48, n=218
|
-1.987 micromoles per liter
Standard Deviation 18.0028
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 5, Week 8, n=218
|
-2.514 micromoles per liter
Standard Deviation 16.1511
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 5, Week 16, n=214
|
-2.602 micromoles per liter
Standard Deviation 16.0764
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 5, Week 24, n=211
|
-1.843 micromoles per liter
Standard Deviation 16.8703
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 5, Week 32, n=211
|
-1.634 micromoles per liter
Standard Deviation 17.1000
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 5, Week 40, n=198
|
-2.456 micromoles per liter
Standard Deviation 17.8333
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 5, Week 48, n=207
|
-3.203 micromoles per liter
Standard Deviation 17.3533
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 6, Week 8, n=206
|
-3.562 micromoles per liter
Standard Deviation 16.8131
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 6, Week 16, n=198
|
-2.634 micromoles per liter
Standard Deviation 26.0097
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 6, Week 24, n=190
|
-4.373 micromoles per liter
Standard Deviation 15.1824
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 6, Week 32, n=193
|
-3.527 micromoles per liter
Standard Deviation 18.6685
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 6, Week 40, n=185
|
-3.488 micromoles per liter
Standard Deviation 19.8547
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 6, Week 48, n=186
|
-3.565 micromoles per liter
Standard Deviation 18.7328
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 7, Week 8, n=179
|
-4.198 micromoles per liter
Standard Deviation 19.0041
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 7, Week 16, n=179
|
-5.185 micromoles per liter
Standard Deviation 20.4159
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 7, Week 24, n=173
|
-6.438 micromoles per liter
Standard Deviation 20.9087
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 7, Week 32, n=180
|
-7.907 micromoles per liter
Standard Deviation 19.4999
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 7, Week 40, n=175
|
-8.486 micromoles per liter
Standard Deviation 15.0558
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 7, Week 48, n=175
|
-8.789 micromoles per liter
Standard Deviation 17.9447
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 8, Week 8, n=171
|
-9.202 micromoles per liter
Standard Deviation 17.7671
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 8, Week 16, n=170
|
-8.008 micromoles per liter
Standard Deviation 19.5492
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 8, Week 24, n=168
|
-8.630 micromoles per liter
Standard Deviation 19.0791
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 8, Week 32, n=168
|
-8.682 micromoles per liter
Standard Deviation 19.2383
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 8, Week 40, n=162
|
-8.349 micromoles per liter
Standard Deviation 21.3658
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 8, Week 48, n=159
|
-8.228 micromoles per liter
Standard Deviation 18.9524
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 9, Week 8, n=164
|
-8.517 micromoles per liter
Standard Deviation 14.5862
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 9, Week 16, n=162
|
-7.585 micromoles per liter
Standard Deviation 20.0682
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 9, Week 24, n=161
|
-8.291 micromoles per liter
Standard Deviation 21.4197
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 9, Week 32, n=163
|
-7.593 micromoles per liter
Standard Deviation 18.2143
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 9, Week 40, n=156
|
-7.763 micromoles per liter
Standard Deviation 18.4432
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 9, Week 48, n=151
|
-8.430 micromoles per liter
Standard Deviation 15.7255
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 10, Week 8, n=152
|
-8.258 micromoles per liter
Standard Deviation 19.3747
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 10, Week 16, n=143
|
-9.273 micromoles per liter
Standard Deviation 14.3973
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 10, Week 24, n=145
|
-7.986 micromoles per liter
Standard Deviation 17.3492
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 10, Week 32, n=142
|
-8.217 micromoles per liter
Standard Deviation 17.1597
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 10, Week 40, n=138
|
-9.417 micromoles per liter
Standard Deviation 16.4848
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 10, Week 48, n=135
|
-8.120 micromoles per liter
Standard Deviation 15.7637
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 11, Week 8, n=138
|
-8.584 micromoles per liter
Standard Deviation 16.5792
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 11, Week 16, n=128
|
-9.254 micromoles per liter
Standard Deviation 16.0322
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 11, Week 24, n=130
|
-8.500 micromoles per liter
Standard Deviation 16.4151
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 11, Week 32, n=125
|
-8.699 micromoles per liter
Standard Deviation 15.1035
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 11, Week 40, n=124
|
-7.058 micromoles per liter
Standard Deviation 19.1292
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 11, Week 48, n=108
|
-7.858 micromoles per liter
Standard Deviation 15.6339
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 12, Week 8, n=110
|
-7.715 micromoles per liter
Standard Deviation 14.5236
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 12, Week 16, n=97
|
-6.744 micromoles per liter
Standard Deviation 13.1845
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 12, Week 24, n=87
|
-7.316 micromoles per liter
Standard Deviation 13.4273
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 12, Week 32, n=84
|
-7.998 micromoles per liter
Standard Deviation 14.5624
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 12, Week 40, n=82
|
-7.331 micromoles per liter
Standard Deviation 14.9482
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 12, Week 48, n=72
|
-8.103 micromoles per liter
Standard Deviation 14.0558
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 13, Week 8, n=53
|
-7.672 micromoles per liter
Standard Deviation 12.1403
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 13, Week 16, n=42
|
-6.104 micromoles per liter
Standard Deviation 9.8570
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 13, Week 24, n=20
|
-9.282 micromoles per liter
Standard Deviation 9.7155
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 13, Week 32, n=7
|
-3.789 micromoles per liter
Standard Deviation 15.1893
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Year 13, Week 40, n=1
|
-8.840 micromoles per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, Exit, n=248
|
-3.707 micromoles per liter
Standard Deviation 21.7147
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, 8-Week Follow-up, n=220
|
-4.058 micromoles per liter
Standard Deviation 21.6587
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Creatinine, 24-Week Follow-up , n=200
|
-5.216 micromoles per liter
Standard Deviation 19.0936
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 1, Week 8, n=284
|
1.8849 micromoles per liter
Standard Deviation 44.3384
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 1, Week 16, n=286
|
-2.8076 micromoles per liter
Standard Deviation 47.4812
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 1, Week 24, n=292
|
-2.6888 micromoles per liter
Standard Deviation 47.8723
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 1, Week 32, n=287
|
-4.9739 micromoles per liter
Standard Deviation 51.9503
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 1, Week 40, n=284
|
-10.2415 micromoles per liter
Standard Deviation 52.6846
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 1, Week 48, n=287
|
-9.6785 micromoles per liter
Standard Deviation 52.9454
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 2, Week 8, n=288
|
-5.8034 micromoles per liter
Standard Deviation 54.3409
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 2, Week 16, n=278
|
-2.2679 micromoles per liter
Standard Deviation 55.1544
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 2, Week 24, n=273
|
-2.5709 micromoles per liter
Standard Deviation 59.5925
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 2, Week 32, n=284
|
-2.1153 micromoles per liter
Standard Deviation 62.2559
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 2, Week 40, n=264
|
0.8111 micromoles per liter
Standard Deviation 59.7227
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 2, Week 48, n=269
|
2.1448 micromoles per liter
Standard Deviation 60.1246
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 3, Week 8, n=265
|
2.1772 micromoles per liter
Standard Deviation 66.2923
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 3, Week 16, n=260
|
8.6246 micromoles per liter
Standard Deviation 60.1972
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 3, Week 24, n=244
|
17.1614 micromoles per liter
Standard Deviation 64.9072
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 3, Week 32, n=249
|
20.6627 micromoles per liter
Standard Deviation 69.7507
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 3, Week 40, n=245
|
15.5862 micromoles per liter
Standard Deviation 64.9204
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 3, Week 48, n=244
|
17.2346 micromoles per liter
Standard Deviation 69.9632
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 4, Week 8, n=239
|
18.8644 micromoles per liter
Standard Deviation 69.2770
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 4, Week 16, n=238
|
17.0443 micromoles per liter
Standard Deviation 65.9764
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 4, Week 24, n=227
|
22.1150 micromoles per liter
Standard Deviation 73.0409
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 4, Week 32, n=233
|
27.1872 micromoles per liter
Standard Deviation 67.0773
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 4, Week 40, n=220
|
20.6017 micromoles per liter
Standard Deviation 77.3509
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 4, Week 48, n=218
|
27.3663 micromoles per liter
Standard Deviation 74.9898
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 5, Week 8, n=218
|
26.3294 micromoles per liter
Standard Deviation 73.0884
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 5, Week 16, n=214
|
26.4325 micromoles per liter
Standard Deviation 75.1583
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 5, Week 24, n=211
|
25.6525 micromoles per liter
Standard Deviation 73.5651
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 5, Week 32, n=211
|
32.0515 micromoles per liter
Standard Deviation 75.9635
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 5, Week 40, n=198
|
26.8862 micromoles per liter
Standard Deviation 77.2803
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 5, Week 48, n=207
|
24.9126 micromoles per liter
Standard Deviation 79.1890
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 6, Week 8, n=206
|
26.3329 micromoles per liter
Standard Deviation 80.0258
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 6, Week 16, n=198
|
27.2166 micromoles per liter
Standard Deviation 79.2525
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 6, Week 24, n=190
|
32.5888 micromoles per liter
Standard Deviation 81.4485
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 6, Week 32, n=193
|
32.3904 micromoles per liter
Standard Deviation 81.4550
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 6, Week 40, n=185
|
34.4019 micromoles per liter
Standard Deviation 75.0211
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 6, Week 48, n=186
|
39.1737 micromoles per liter
Standard Deviation 75.6743
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 7, Week 8, n=179
|
34.0930 micromoles per liter
Standard Deviation 75.0241
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 7, Week 16, n=179
|
35.0566 micromoles per liter
Standard Deviation 77.2918
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 7, Week 24, n=173
|
34.7941 micromoles per liter
Standard Deviation 80.7184
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 7, Week 32, n=180
|
32.8792 micromoles per liter
Standard Deviation 75.6337
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 7, Week 40, n=175
|
31.7453 micromoles per liter
Standard Deviation 81.9889
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 7, Week 48, n=175
|
31.9832 micromoles per liter
Standard Deviation 78.3131
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 8, Week 8, n=171
|
26.6790 micromoles per liter
Standard Deviation 79.7678
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 8, Week 16, n=170
|
30.7197 micromoles per liter
Standard Deviation 83.1681
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 8, Week 24, n=168
|
25.4560 micromoles per liter
Standard Deviation 83.0349
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 8, Week 32, n=168
|
30.0940 micromoles per liter
Standard Deviation 81.9997
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 8, Week 40, n=162
|
29.4096 micromoles per liter
Standard Deviation 76.1203
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 8, Week 48, n=159
|
29.9270 micromoles per liter
Standard Deviation 82.9390
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 9, Week 8, n=164
|
37.6828 micromoles per liter
Standard Deviation 78.7998
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 9, Week 16, n=162
|
27.2066 micromoles per liter
Standard Deviation 79.3972
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 9, Week 24, n=161
|
25.9717 micromoles per liter
Standard Deviation 78.7793
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 9, Week 32, n=163
|
26.1639 micromoles per liter
Standard Deviation 78.0704
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 9, Week 40, n=156
|
24.7833 micromoles per liter
Standard Deviation 81.4956
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 9, Week 48, n=151
|
21.9012 micromoles per liter
Standard Deviation 82.0174
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 10, Week 8, n=152
|
24.8486 micromoles per liter
Standard Deviation 75.5325
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 10, Week 16, n=143
|
17.5528 micromoles per liter
Standard Deviation 82.4129
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 10, Week 24, n=145
|
17.6389 micromoles per liter
Standard Deviation 88.8154
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 10, Week 32, n=142
|
16.9644 micromoles per liter
Standard Deviation 84.0128
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 10, Week 40, n=138
|
16.0768 micromoles per liter
Standard Deviation 88.6943
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 10, Week 48, n=135
|
20.9722 micromoles per liter
Standard Deviation 92.2400
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 11, Week 8, n=138
|
16.3354 micromoles per liter
Standard Deviation 88.7370
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 11, Week 16, n=128
|
19.0057 micromoles per liter
Standard Deviation 80.9138
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 11, Week 24, n=129
|
13.8326 micromoles per liter
Standard Deviation 91.9844
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 11, Week 32, n=125
|
14.4180 micromoles per liter
Standard Deviation 81.6362
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 11, Week 40, n=124
|
17.8920 micromoles per liter
Standard Deviation 97.1467
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 11, Week 48, n=108
|
15.9164 micromoles per liter
Standard Deviation 86.7371
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 12, Week 8, n=110
|
18.3307 micromoles per liter
Standard Deviation 92.3013
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 12, Week 16, n=97
|
15.3912 micromoles per liter
Standard Deviation 85.1873
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 12, Week 24, n=87
|
15.3828 micromoles per liter
Standard Deviation 87.1985
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 12, Week 32, n=84
|
16.7817 micromoles per liter
Standard Deviation 89.8376
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 12, Week 40, n=82
|
12.2587 micromoles per liter
Standard Deviation 83.5304
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 12, Week 48, n=72
|
9.9133 micromoles per liter
Standard Deviation 85.1185
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 13, Week 8, n=53
|
32.4334 micromoles per liter
Standard Deviation 79.1035
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 13, Week 16, n=42
|
42.6273 micromoles per liter
Standard Deviation 74.2314
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 13, Week 24, n=20
|
25.5764 micromoles per liter
Standard Deviation 56.8583
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 13, Week 32, n=7
|
64.5783 micromoles per liter
Standard Deviation 59.0251
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Year 13, Week 40, n=1
|
53.5320 micromoles per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, Exit, n=248
|
18.5635 micromoles per liter
Standard Deviation 89.4280
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, 8-Week Follow-up, n=220
|
19.6014 micromoles per liter
Standard Deviation 89.9097
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Urate, 24-Week Follow-up , n=200
|
17.5763 micromoles per liter
Standard Deviation 82.1420
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 1, Week 8, n=283
|
0.145 micromoles per liter
Standard Deviation 2.2995
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 2, Week 32, n=284
|
0.331 micromoles per liter
Standard Deviation 2.6475
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 2, Week 40, n=262
|
0.398 micromoles per liter
Standard Deviation 2.9233
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 2, Week 48, n=269
|
0.464 micromoles per liter
Standard Deviation 2.5138
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 3, Week 8, n=264
|
0.343 micromoles per liter
Standard Deviation 2.6599
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 3, Week 16, n=258
|
0.252 micromoles per liter
Standard Deviation 2.8788
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 3, Week 24, n=243
|
0.274 micromoles per liter
Standard Deviation 3.0754
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 3, Week 32, n=249
|
0.494 micromoles per liter
Standard Deviation 2.5860
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 3, Week 40, n=244
|
0.182 micromoles per liter
Standard Deviation 2.8589
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 3, Week 48, n=243
|
0.267 micromoles per liter
Standard Deviation 3.0780
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 4, Week 8, n=239
|
0.336 micromoles per liter
Standard Deviation 2.7639
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 4, Week 16, n=238
|
0.481 micromoles per liter
Standard Deviation 2.8625
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 4, Week 24, n=227
|
0.309 micromoles per liter
Standard Deviation 2.8038
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 4, Week 32, n=231
|
0.326 micromoles per liter
Standard Deviation 2.9524
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 4, Week 40, n=220
|
-0.023 micromoles per liter
Standard Deviation 2.5236
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 4, Week 48, n=218
|
0.157 micromoles per liter
Standard Deviation 2.8815
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 5, Week 8, n=218
|
0.329 micromoles per liter
Standard Deviation 2.4013
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 5, Week 16, n=214
|
0.304 micromoles per liter
Standard Deviation 2.6180
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 5, Week 24, n=211
|
0.259 micromoles per liter
Standard Deviation 2.5450
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 5, Week 32, n=211
|
0.575 micromoles per liter
Standard Deviation 2.6520
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 5, Week 40, n=198
|
0.544 micromoles per liter
Standard Deviation 2.6496
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 5, Week 48, n=207
|
0.322 micromoles per liter
Standard Deviation 2.5320
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 6, Week 8, n=206
|
0.282 micromoles per liter
Standard Deviation 2.5233
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 6, Week 16, n=198
|
0.138 micromoles per liter
Standard Deviation 2.6093
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 6, Week 24, n=190
|
0.099 micromoles per liter
Standard Deviation 2.7600
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 6, Week 32, n=193
|
0.284 micromoles per liter
Standard Deviation 2.6431
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 6, Week 40, n=185
|
0.296 micromoles per liter
Standard Deviation 2.8314
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 6, Week 48, n=186
|
0.248 micromoles per liter
Standard Deviation 3.0097
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 7, Week 8, n=179
|
0.258 micromoles per liter
Standard Deviation 2.6974
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 7, Week 16, n=179
|
0.143 micromoles per liter
Standard Deviation 2.6134
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 7, Week 24, n=173
|
0.287 micromoles per liter
Standard Deviation 2.6082
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 7, Week 32, n=180
|
0.313 micromoles per liter
Standard Deviation 2.9727
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 7, Week 40, n=175
|
0.137 micromoles per liter
Standard Deviation 2.7527
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 7, Week 48, n=175
|
0.156 micromoles per liter
Standard Deviation 2.9747
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 8, Week 8, n=171
|
0.020 micromoles per liter
Standard Deviation 2.9559
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 8, Week 16, n=170
|
-0.050 micromoles per liter
Standard Deviation 2.6856
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 8, Week 24, n=168
|
0.010 micromoles per liter
Standard Deviation 2.4720
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 8, Week 32, n=168
|
-0.336 micromoles per liter
Standard Deviation 2.5471
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 8, Week 40, n=162
|
-0.032 micromoles per liter
Standard Deviation 2.8934
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 8, Week 48, n=159
|
-0.097 micromoles per liter
Standard Deviation 3.2550
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 9, Week 8, n=164
|
-0.125 micromoles per liter
Standard Deviation 2.7616
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 9, Week 16, n=162
|
-0.095 micromoles per liter
Standard Deviation 2.9603
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 9, Week 24, n=161
|
-0.234 micromoles per liter
Standard Deviation 3.1385
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 9, Week 32, n=163
|
-0.126 micromoles per liter
Standard Deviation 2.7175
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 9, Week 40, n=156
|
-0.296 micromoles per liter
Standard Deviation 3.3709
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 9, Week 48, n=151
|
0.057 micromoles per liter
Standard Deviation 2.8231
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 10, Week 8, n=152
|
-0.158 micromoles per liter
Standard Deviation 3.0763
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 10, Week 16, n=143
|
-0.179 micromoles per liter
Standard Deviation 3.1616
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 10, Week 24, n=145
|
-0.024 micromoles per liter
Standard Deviation 2.8853
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 10, Week 32, n=142
|
0.120 micromoles per liter
Standard Deviation 3.3068
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 10, Week 40, n=138
|
-0.248 micromoles per liter
Standard Deviation 3.0684
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 10, Week 48, n=135
|
0.190 micromoles per liter
Standard Deviation 3.0751
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 11, Week 8, n=138
|
0.050 micromoles per liter
Standard Deviation 2.9936
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 11, Week 16, n=128
|
0.281 micromoles per liter
Standard Deviation 2.9640
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 11, Week 24, n=130
|
0.026 micromoles per liter
Standard Deviation 2.8004
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 11, Week 32, n=125
|
0.192 micromoles per liter
Standard Deviation 2.5160
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 11, Week 40, n=124
|
0.193 micromoles per liter
Standard Deviation 3.2650
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 11, Week 48, n=108
|
0.538 micromoles per liter
Standard Deviation 2.9261
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 12, Week 8, n=110
|
0.311 micromoles per liter
Standard Deviation 2.8762
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 12, Week 16, n=97
|
0.776 micromoles per liter
Standard Deviation 3.0231
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 12, Week 24, n=87
|
0.511 micromoles per liter
Standard Deviation 3.4508
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 12, Week 32, n=84
|
1.282 micromoles per liter
Standard Deviation 3.3563
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 12, Week 40, n=82
|
0.542 micromoles per liter
Standard Deviation 3.2454
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 12, Week 48, n=72
|
0.570 micromoles per liter
Standard Deviation 3.8398
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 13, Week 8, n=53
|
0.129 micromoles per liter
Standard Deviation 2.8623
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 13, Week 16, n=42
|
-0.244 micromoles per liter
Standard Deviation 3.1046
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 13, Week 24, n=20
|
-0.513 micromoles per liter
Standard Deviation 2.0080
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 13, Week 32, n=7
|
-0.244 micromoles per liter
Standard Deviation 2.5032
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Year 13, Week 40, n=1
|
0.000 micromoles per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, Exit, n=248
|
0.510 micromoles per liter
Standard Deviation 3.0619
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, 8-Week Follow-up, n=220
|
0.389 micromoles per liter
Standard Deviation 2.7311
|
|
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Bilirubin, 24-Week Follow-up , n=200
|
0.650 micromoles per liter
Standard Deviation 3.3222
|
PRIMARY outcome
Timeframe: Baseline and approximately up to 13 yearsPopulation: MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Extension 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.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=296 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 1, Week 8, n=284
|
-0.1 Ratio
Standard Deviation 4.13
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 1, Week 16, n=286
|
-0.4 Ratio
Standard Deviation 4.31
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 1, Week 24, n=292
|
-0.4 Ratio
Standard Deviation 4.67
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 1, Week 32, n=287
|
-0.4 Ratio
Standard Deviation 4.07
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 1, Week 40, n=284
|
-0.8 Ratio
Standard Deviation 4.26
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 1, Week 48, n=287
|
-0.3 Ratio
Standard Deviation 4.80
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 2, Week 8, n=288
|
-0.4 Ratio
Standard Deviation 4.91
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 2, Week 16, n=278
|
-0.6 Ratio
Standard Deviation 4.95
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 2, Week 24, n=273
|
-0.6 Ratio
Standard Deviation 5.00
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 2, Week 32, n=284
|
-0.4 Ratio
Standard Deviation 4.82
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 2, Week 40, n=264
|
-0.8 Ratio
Standard Deviation 4.80
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 2, Week 48, n=269
|
-0.5 Ratio
Standard Deviation 4.90
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 3, Week 8, n=265
|
0.2 Ratio
Standard Deviation 4.81
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 3, Week 16, n=260
|
0.2 Ratio
Standard Deviation 4.95
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 3, Week 24, n=244
|
0.6 Ratio
Standard Deviation 4.93
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 3, Week 32, n=249
|
0.5 Ratio
Standard Deviation 5.16
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 3, Week 40, n=245
|
0.9 Ratio
Standard Deviation 4.83
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 3, Week 48, n=244
|
0.8 Ratio
Standard Deviation 4.99
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 4, Week 8, n=239
|
1.1 Ratio
Standard Deviation 4.99
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 4, Week 16, n=238
|
0.8 Ratio
Standard Deviation 4.86
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 4, Week 24, n=227
|
0.9 Ratio
Standard Deviation 5.15
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 4, Week 32, n=233
|
0.5 Ratio
Standard Deviation 4.93
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 4, Week 40, n=220
|
0.3 Ratio
Standard Deviation 4.81
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 4, Week 48, n=218
|
1.1 Ratio
Standard Deviation 5.35
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 5, Week 8, n=218
|
0.8 Ratio
Standard Deviation 5.34
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 5, Week 16, n=214
|
1.2 Ratio
Standard Deviation 5.03
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 5, Week 24, n=211
|
0.8 Ratio
Standard Deviation 5.01
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 5, Week 32, n=211
|
0.3 Ratio
Standard Deviation 4.93
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 5, Week 40, n=198
|
1.2 Ratio
Standard Deviation 5.04
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 5, Week 48, n=207
|
0.9 Ratio
Standard Deviation 5.11
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 6, Week 8, n=206
|
1.4 Ratio
Standard Deviation 5.04
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 6, Week 16, n=198
|
1.3 Ratio
Standard Deviation 5.03
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 6, Week 24, n=190
|
1.2 Ratio
Standard Deviation 5.37
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 6, Week 32, n=193
|
1.6 Ratio
Standard Deviation 5.76
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 6, Week 40, n=185
|
1.5 Ratio
Standard Deviation 4.73
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 6, Week 48, n=186
|
1.8 Ratio
Standard Deviation 5.08
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 7, Week 8, n=179
|
1.6 Ratio
Standard Deviation 5.07
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 7, Week 16, n=179
|
2.1 Ratio
Standard Deviation 5.04
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 7, Week 24, n=173
|
2.1 Ratio
Standard Deviation 5.55
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 7, Week 32, n=180
|
2.3 Ratio
Standard Deviation 5.39
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 7, Week 40, n=175
|
2.6 Ratio
Standard Deviation 5.19
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 7, Week 48, n=175
|
2.6 Ratio
Standard Deviation 5.31
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 8, Week 8, n=171
|
2.7 Ratio
Standard Deviation 5.65
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 8, Week 16, n=170
|
2.5 Ratio
Standard Deviation 5.54
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 8, Week 24, n=168
|
2.6 Ratio
Standard Deviation 5.37
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 8, Week 32, n=168
|
2.2 Ratio
Standard Deviation 5.11
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 8, Week 40, n=162
|
2.3 Ratio
Standard Deviation 5.36
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 8, Week 48, n=159
|
2.9 Ratio
Standard Deviation 5.20
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 9, Week 8, n=164
|
2.4 Ratio
Standard Deviation 5.26
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 9, Week 16, n=162
|
2.5 Ratio
Standard Deviation 6.15
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 9, Week 24, n=161
|
2.4 Ratio
Standard Deviation 5.89
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 9, Week 32, n=163
|
2.7 Ratio
Standard Deviation 5.54
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 9, Week 40, n=156
|
2.4 Ratio
Standard Deviation 5.90
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 9, Week 48, n=151
|
2.2 Ratio
Standard Deviation 6.01
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 10, Week 8, n=152
|
2.6 Ratio
Standard Deviation 5.98
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 10, Week 16, n=143
|
2.6 Ratio
Standard Deviation 6.13
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 10, Week 24, n=145
|
2.5 Ratio
Standard Deviation 5.72
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 10, Week 32, n=142
|
2.8 Ratio
Standard Deviation 6.03
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 10, Week 40, n=138
|
2.0 Ratio
Standard Deviation 5.87
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 10, Week 48, n=135
|
2.4 Ratio
Standard Deviation 6.07
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 11, Week 8, n=138
|
2.7 Ratio
Standard Deviation 6.13
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 11, Week 16, n=128
|
2.6 Ratio
Standard Deviation 6.28
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 11, Week 24, n=130
|
2.8 Ratio
Standard Deviation 6.12
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 11, Week 32, n=125
|
2.2 Ratio
Standard Deviation 6.10
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 11, Week 40, n=124
|
2.3 Ratio
Standard Deviation 6.68
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 11, Week 48, n=108
|
1.7 Ratio
Standard Deviation 5.65
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 12, Week 8, n=110
|
2.4 Ratio
Standard Deviation 6.36
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 12, Week 16, n=97
|
2.4 Ratio
Standard Deviation 6.38
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 12, Week 24, n=87
|
2.2 Ratio
Standard Deviation 6.62
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 12, Week 32, n=84
|
1.5 Ratio
Standard Deviation 5.75
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 12, Week 40, n=82
|
1.4 Ratio
Standard Deviation 6.50
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 12, Week 48, n=72
|
1.6 Ratio
Standard Deviation 6.42
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 13, Week 8, n=53
|
2.1 Ratio
Standard Deviation 5.44
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 13, Week 16, n=42
|
3.5 Ratio
Standard Deviation 6.22
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 13, Week 24, n=20
|
3.6 Ratio
Standard Deviation 4.36
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 13, Week 32, n=7
|
0.3 Ratio
Standard Deviation 2.93
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Year 13, Week 40, n=1
|
-6.0 Ratio
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, Exit, n=248
|
1.6 Ratio
Standard Deviation 5.66
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, 8-Week Follow-up, n=220
|
1.1 Ratio
Standard Deviation 5.88
|
|
Change From Baseline in BUN/Creatinine at the Indicated Time Points
BUN/Creatinine, 24-Week Follow-up , n=200
|
1.3 Ratio
Standard Deviation 5.53
|
PRIMARY outcome
Timeframe: Baseline and approximately up to 13 yearsPopulation: MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in ALT, AP, AST, GGT and LD are summarized. Baseline is defined as the Extension 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.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=296 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 2, Week 40, n=264
|
3.5 International units per liter
Standard Deviation 19.55
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 2, Week 48, n=269
|
5.6 International units per liter
Standard Deviation 23.81
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 3, Week 8, n=265
|
4.0 International units per liter
Standard Deviation 18.04
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 3, Week 16, n=260
|
3.2 International units per liter
Standard Deviation 19.53
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 3, Week 24, n=244
|
2.0 International units per liter
Standard Deviation 19.26
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 3, Week 32, n=249
|
3.7 International units per liter
Standard Deviation 21.48
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 3, Week 40, n=245
|
3.4 International units per liter
Standard Deviation 18.62
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 3, Week 48, n=244
|
3.4 International units per liter
Standard Deviation 19.32
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 4, Week 8, n=239
|
2.5 International units per liter
Standard Deviation 19.33
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 4, Week 16, n=238
|
2.8 International units per liter
Standard Deviation 17.37
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 4, Week 24, n=227
|
2.5 International units per liter
Standard Deviation 21.94
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 4, Week 32, n=233
|
3.7 International units per liter
Standard Deviation 21.17
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 6, Week 16, n=198
|
7.5 International units per liter
Standard Deviation 21.41
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 6, Week 24, n=190
|
7.5 International units per liter
Standard Deviation 22.41
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 4, Week 40, n=220
|
2.9 International units per liter
Standard Deviation 20.93
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 4, Week 48, n=218
|
3.7 International units per liter
Standard Deviation 22.97
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 5, Week 8, n=218
|
4.9 International units per liter
Standard Deviation 24.65
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 5, Week 16, n=214
|
4.1 International units per liter
Standard Deviation 23.87
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 5, Week 24, n=211
|
4.0 International units per liter
Standard Deviation 20.17
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 5, Week 32, n=211
|
5.7 International units per liter
Standard Deviation 20.68
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 5, Week 40, n=198
|
5.5 International units per liter
Standard Deviation 21.34
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 5, Week 48, n=207
|
6.6 International units per liter
Standard Deviation 21.74
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 6, Week 8, n=206
|
7.1 International units per liter
Standard Deviation 23.65
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 6, Week 32, n=193
|
14.0 International units per liter
Standard Deviation 67.61
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 6, Week 40, n=185
|
10.2 International units per liter
Standard Deviation 24.43
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 6, Week 48, n=186
|
9.1 International units per liter
Standard Deviation 22.93
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 7, Week 8, n=179
|
9.0 International units per liter
Standard Deviation 24.52
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 1, Week 8, n=284
|
-0.7 International units per liter
Standard Deviation 12.05
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 1, Week 16, n=286
|
0.2 International units per liter
Standard Deviation 17.32
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 1, Week 24, n=292
|
0.9 International units per liter
Standard Deviation 17.04
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 1, Week 32, n=287
|
-0.6 International units per liter
Standard Deviation 12.36
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 1, Week 40, n=284
|
-0.6 International units per liter
Standard Deviation 14.15
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 1, Week 48, n=287
|
-1.3 International units per liter
Standard Deviation 11.56
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 2, Week 8, n=288
|
-0.7 International units per liter
Standard Deviation 13.36
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 2, Week 16, n=278
|
-1.2 International units per liter
Standard Deviation 11.44
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 2, Week 24, n=273
|
0.3 International units per liter
Standard Deviation 13.35
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 2, Week 32, n=284
|
0.1 International units per liter
Standard Deviation 15.85
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 2, Week 40, n=264
|
0.0 International units per liter
Standard Deviation 14.02
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 2, Week 48, n=269
|
0.9 International units per liter
Standard Deviation 15.65
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 3, Week 8, n=265
|
0.5 International units per liter
Standard Deviation 14.46
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 3, Week 16, n=260
|
1.3 International units per liter
Standard Deviation 21.94
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 3, Week 24, n=244
|
-0.1 International units per liter
Standard Deviation 13.95
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 3, Week 32, n=249
|
0.0 International units per liter
Standard Deviation 12.55
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 3, Week 40, n=245
|
-0.3 International units per liter
Standard Deviation 13.08
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 3, Week 48, n=244
|
-0.4 International units per liter
Standard Deviation 13.62
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 4, Week 8, n=239
|
-0.5 International units per liter
Standard Deviation 10.97
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 4, Week 16, n=238
|
-1.3 International units per liter
Standard Deviation 14.28
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 4, Week 24, n=227
|
-1.3 International units per liter
Standard Deviation 13.29
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 4, Week 32, n=233
|
-0.4 International units per liter
Standard Deviation 13.60
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 4, Week 40, n=220
|
-1.6 International units per liter
Standard Deviation 12.83
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 4, Week 48, n=218
|
-1.3 International units per liter
Standard Deviation 12.45
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 5, Week 8, n=218
|
0.1 International units per liter
Standard Deviation 12.76
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 5, Week 16, n=214
|
-0.5 International units per liter
Standard Deviation 12.67
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 5, Week 24, n=211
|
-0.9 International units per liter
Standard Deviation 14.68
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 5, Week 32, n=211
|
-1.5 International units per liter
Standard Deviation 13.23
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 5, Week 40, n=198
|
-1.3 International units per liter
Standard Deviation 13.90
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 5, Week 48, n=207
|
-0.1 International units per liter
Standard Deviation 17.16
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 6, Week 8, n=206
|
-1.4 International units per liter
Standard Deviation 12.09
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 6, Week 16, n=198
|
-1.4 International units per liter
Standard Deviation 13.55
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 6, Week 24, n=190
|
-1.6 International units per liter
Standard Deviation 13.87
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 6, Week 32, n=193
|
-1.4 International units per liter
Standard Deviation 13.58
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 6, Week 40, n=185
|
-1.4 International units per liter
Standard Deviation 14.78
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 6, Week 48, n=186
|
-0.9 International units per liter
Standard Deviation 14.98
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 7, Week 8, n=179
|
-0.4 International units per liter
Standard Deviation 14.50
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 7, Week 16, n=179
|
0.5 International units per liter
Standard Deviation 15.78
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 7, Week 24, n=173
|
0.1 International units per liter
Standard Deviation 16.09
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 7, Week 32, n=180
|
-0.2 International units per liter
Standard Deviation 14.71
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 7, Week 40, n=175
|
-0.1 International units per liter
Standard Deviation 16.43
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 7, Week 48, n=175
|
-0.4 International units per liter
Standard Deviation 16.15
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 8, Week 8, n=171
|
0.9 International units per liter
Standard Deviation 16.58
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 8, Week 16, n=170
|
-0.2 International units per liter
Standard Deviation 17.74
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 8, Week 24, n=168
|
-0.2 International units per liter
Standard Deviation 15.62
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 8, Week 32, n=168
|
-0.4 International units per liter
Standard Deviation 14.82
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 8, Week 40, n=162
|
-0.7 International units per liter
Standard Deviation 14.79
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 8, Week 48, n=159
|
-0.7 International units per liter
Standard Deviation 15.14
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 9, Week 8, n=164
|
1.5 International units per liter
Standard Deviation 21.38
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 9, Week 16, n=162
|
-0.8 International units per liter
Standard Deviation 14.31
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 9, Week 24, n=161
|
-1.5 International units per liter
Standard Deviation 14.35
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 9, Week 32, n=163
|
0.0 International units per liter
Standard Deviation 15.62
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 9, Week 40, n=156
|
-0.5 International units per liter
Standard Deviation 14.61
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 9, Week 48, n=151
|
-0.2 International units per liter
Standard Deviation 15.69
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 10, Week 8, n=152
|
-0.6 International units per liter
Standard Deviation 14.25
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 10, Week 16, n=143
|
-0.3 International units per liter
Standard Deviation 13.88
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 10, Week 24, n=145
|
-1.1 International units per liter
Standard Deviation 15.71
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 10, Week 32, n=142
|
-0.8 International units per liter
Standard Deviation 15.97
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 10, Week 40, n=138
|
-1.9 International units per liter
Standard Deviation 15.56
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 10, Week 48, n=135
|
-0.7 International units per liter
Standard Deviation 19.61
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 11, Week 8, n=138
|
-1.9 International units per liter
Standard Deviation 15.75
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 11, Week 16, n=128
|
-1.3 International units per liter
Standard Deviation 16.74
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 11, Week 24, n=130
|
-2.5 International units per liter
Standard Deviation 15.11
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 11, Week 32, n=125
|
-3.2 International units per liter
Standard Deviation 14.71
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 11, Week 40, n=124
|
-2.8 International units per liter
Standard Deviation 15.31
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 11, Week 48, n=108
|
-1.7 International units per liter
Standard Deviation 18.29
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 12, Week 8, n=110
|
-1.9 International units per liter
Standard Deviation 16.30
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 12, Week 16, n=97
|
-2.9 International units per liter
Standard Deviation 12.74
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 12, Week 24, n=87
|
-2.0 International units per liter
Standard Deviation 13.47
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 12, Week 32, n=84
|
-2.4 International units per liter
Standard Deviation 13.39
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 12, Week 40, n=82
|
-2.3 International units per liter
Standard Deviation 14.74
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 12, Week 48, n=72
|
-3.6 International units per liter
Standard Deviation 14.92
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 13, Week 8, n=53
|
-5.3 International units per liter
Standard Deviation 16.58
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LT, Year 13, Week 16, n=42
|
-5.7 International units per liter
Standard Deviation 20.42
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 13, Week 24, n=20
|
-1.0 International units per liter
Standard Deviation 6.55
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 13, Week 32, n=7
|
-0.6 International units per liter
Standard Deviation 9.14
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Year 13, Week 40, n=1
|
3.0 International units per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, Exit, n=248
|
-1.2 International units per liter
Standard Deviation 13.39
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 1, Week 24, n=292
|
0.7 International units per liter
Standard Deviation 13.87
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 1, Week 32, n=287
|
0.6 International units per liter
Standard Deviation 14.03
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 1, Week 40, n=284
|
1.1 International units per liter
Standard Deviation 14.61
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 1, Week 48, n=287
|
0.5 International units per liter
Standard Deviation 16.94
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, 8-Week Follow-up, n=220
|
-0.6 International units per liter
Standard Deviation 15.74
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
ALT, 24-Week Follow-up , n=200
|
1.5 International units per liter
Standard Deviation 36.52
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 1, Week 8, n=284
|
-0.1 International units per liter
Standard Deviation 11.43
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 1, Week 16, n=286
|
0.9 International units per liter
Standard Deviation 14.08
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 2, Week 24, n=273
|
1.3 International units per liter
Standard Deviation 16.91
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 2, Week 8, n=288
|
1.2 International units per liter
Standard Deviation 17.67
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 2, Week 16, n=278
|
0.2 International units per liter
Standard Deviation 15.87
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 2, Week 32, n=284
|
2.5 International units per liter
Standard Deviation 17.17
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 7, Week 16, n=179
|
9.6 International units per liter
Standard Deviation 25.70
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 7, Week 24, n=173
|
9.9 International units per liter
Standard Deviation 25.38
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 7, Week 32, n=180
|
11.5 International units per liter
Standard Deviation 27.02
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 7, Week 40, n=175
|
9.6 International units per liter
Standard Deviation 25.13
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 7, Week 48, n=175
|
11.1 International units per liter
Standard Deviation 24.96
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 8, Week 8, n=171
|
10.0 International units per liter
Standard Deviation 23.29
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 8, Week 16, n=170
|
10.1 International units per liter
Standard Deviation 27.16
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 8, Week 24, n=168
|
10.4 International units per liter
Standard Deviation 26.44
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 8, Week 32, n=168
|
12.9 International units per liter
Standard Deviation 27.45
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 8, Week 40, n=162
|
11.1 International units per liter
Standard Deviation 25.66
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 8, Week 48, n=159
|
11.5 International units per liter
Standard Deviation 30.97
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 9, Week 8, n=164
|
12.0 International units per liter
Standard Deviation 25.38
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 9, Week 16, n=162
|
10.9 International units per liter
Standard Deviation 25.48
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 9, Week 24, n=161
|
10.5 International units per liter
Standard Deviation 22.81
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 9, Week 32, n=163
|
10.4 International units per liter
Standard Deviation 24.05
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 9, Week 40, n=156
|
9.5 International units per liter
Standard Deviation 24.43
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 9, Week 48, n=151
|
10.2 International units per liter
Standard Deviation 22.77
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 10, Week 8, n=152
|
10.6 International units per liter
Standard Deviation 24.51
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 10, Week 16, n=143
|
11.9 International units per liter
Standard Deviation 29.31
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 10, Week 24, n=145
|
13.0 International units per liter
Standard Deviation 22.92
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 10, Week 32, n=142
|
14.4 International units per liter
Standard Deviation 24.55
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 10, Week 40, n=138
|
13.7 International units per liter
Standard Deviation 23.20
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 10, Week 48, n=135
|
12.5 International units per liter
Standard Deviation 23.89
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 11, Week 8, n=138
|
13.3 International units per liter
Standard Deviation 26.11
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 11, Week 16, n=128
|
14.2 International units per liter
Standard Deviation 26.05
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 11, Week 24, n=130
|
12.9 International units per liter
Standard Deviation 23.22
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 11, Week 32, n=125
|
13.3 International units per liter
Standard Deviation 23.74
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 11, Week 40, n=124
|
13.3 International units per liter
Standard Deviation 23.05
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 11, Week 48, n=108
|
11.9 International units per liter
Standard Deviation 25.59
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 12, Week 8, n=110
|
12.3 International units per liter
Standard Deviation 25.69
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 12, Week 16, n=97
|
10.2 International units per liter
Standard Deviation 22.48
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 12, Week 24, n=87
|
11.5 International units per liter
Standard Deviation 20.69
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 12, Week 32, n=84
|
10.7 International units per liter
Standard Deviation 19.91
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 12, Week 40, n=82
|
10.8 International units per liter
Standard Deviation 21.35
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 12, Week 48, n=72
|
11.6 International units per liter
Standard Deviation 21.77
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 13, Week 8, n=53
|
12.2 International units per liter
Standard Deviation 19.25
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 13, Week 16, n=42
|
16.9 International units per liter
Standard Deviation 37.69
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 13, Week 24, n=20
|
20.7 International units per liter
Standard Deviation 23.57
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 13, Week 32, n=7
|
18.1 International units per liter
Standard Deviation 21.47
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Year 13, Week 40, n=1
|
15.0 International units per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, Exit, n=248
|
8.3 International units per liter
Standard Deviation 26.49
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, 8-Week Follow-up, n=220
|
10.3 International units per liter
Standard Deviation 42.15
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AP, 24-Week Follow-up , n=200
|
10.7 International units per liter
Standard Deviation 32.86
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 1, Week 8, n=281
|
-0.3 International units per liter
Standard Deviation 8.68
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 1, Week 16, n=283
|
2.0 International units per liter
Standard Deviation 22.78
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 1, Week 24, n=287
|
2.3 International units per liter
Standard Deviation 26.94
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 1, Week 32, n=283
|
0.5 International units per liter
Standard Deviation 12.19
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 1, Week 40, n=282
|
-0.1 International units per liter
Standard Deviation 9.63
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 1, Week 48, n=284
|
-1.2 International units per liter
Standard Deviation 6.98
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 2, Week 8, n=288
|
-0.8 International units per liter
Standard Deviation 9.15
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 2, Week 16, n=275
|
-1.2 International units per liter
Standard Deviation 8.51
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 2, Week 24, n=269
|
-0.3 International units per liter
Standard Deviation 9.04
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 2, Week 32, n=284
|
0.2 International units per liter
Standard Deviation 13.80
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 2, Week 40, n=261
|
-0.2 International units per liter
Standard Deviation 10.44
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 2, Week 48, n=267
|
0.7 International units per liter
Standard Deviation 10.95
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 3, Week 8, n=262
|
0.3 International units per liter
Standard Deviation 10.81
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 3, Week 16, n=258
|
1.0 International units per liter
Standard Deviation 11.84
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 3, Week 24, n=241
|
0.4 International units per liter
Standard Deviation 10.36
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 3, Week 32, n=245
|
1.3 International units per liter
Standard Deviation 11.19
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 3, Week 40, n=242
|
0.2 International units per liter
Standard Deviation 10.99
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 3, Week 48, n=239
|
0.6 International units per liter
Standard Deviation 10.60
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 4, Week 8, n=237
|
0.5 International units per liter
Standard Deviation 7.73
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 4, Week 16, n=235
|
-0.2 International units per liter
Standard Deviation 12.78
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 4, Week 24, n=226
|
0.4 International units per liter
Standard Deviation 11.45
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 4, Week 32, n=230
|
0.8 International units per liter
Standard Deviation 9.26
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 4, Week 40, n=218
|
-0.3 International units per liter
Standard Deviation 9.44
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 4, Week 48, n=214
|
-0.2 International units per liter
Standard Deviation 9.48
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 5, Week 8, n=217
|
0.3 International units per liter
Standard Deviation 12.79
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 5, Week 16, n=213
|
0.8 International units per liter
Standard Deviation 15.76
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 5, Week 24, n=206
|
-0.5 International units per liter
Standard Deviation 11.36
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 5, Week 32, n=211
|
-0.8 International units per liter
Standard Deviation 10.64
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 5, Week 40, n=197
|
0.3 International units per liter
Standard Deviation 14.39
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 5, Week 48, n=207
|
0.0 International units per liter
Standard Deviation 11.58
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 6, Week 8, n=205
|
-0.4 International units per liter
Standard Deviation 9.04
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 6, Week 16, n=198
|
-0.7 International units per liter
Standard Deviation 9.83
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 6, Week 24, n=189
|
-0.9 International units per liter
Standard Deviation 11.35
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 6, Week 32, n=192
|
-0.6 International units per liter
Standard Deviation 11.04
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 6, Week 40, n=181
|
-0.7 International units per liter
Standard Deviation 10.56
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 6, Week 48, n=186
|
0.1 International units per liter
Standard Deviation 12.21
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 7, Week 8, n=177
|
-0.2 International units per liter
Standard Deviation 10.76
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 7, Week 16, n=178
|
1.0 International units per liter
Standard Deviation 12.91
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 7, Week 24, n=171
|
1.5 International units per liter
Standard Deviation 14.44
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 7, Week 32, n=179
|
0.5 International units per liter
Standard Deviation 10.56
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 7, Week 40, n=172
|
0.4 International units per liter
Standard Deviation 14.51
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 7, Week 48, n=175
|
0.2 International units per liter
Standard Deviation 11.15
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 8, Week 8, n=170
|
1.0 International units per liter
Standard Deviation 16.78
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 8, Week 16, n=169
|
1.0 International units per liter
Standard Deviation 21.12
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 8, Week 24, n=167
|
0.5 International units per liter
Standard Deviation 13.61
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 8, Week 32, n=166
|
0.7 International units per liter
Standard Deviation 14.74
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 8, Week 40, n=161
|
1.4 International units per liter
Standard Deviation 16.28
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 8, Week 48, n=159
|
0.2 International units per liter
Standard Deviation 11.00
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 9, Week 8, n=163
|
1.6 International units per liter
Standard Deviation 16.09
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 9, Week 16, n=160
|
0.8 International units per liter
Standard Deviation 13.55
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 9, Week 24, n=160
|
0.3 International units per liter
Standard Deviation 12.60
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 9, Week 32, n=162
|
1.3 International units per liter
Standard Deviation 17.39
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 9, Week 40, n=156
|
1.0 International units per liter
Standard Deviation 14.17
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 9, Week 48, n=150
|
1.5 International units per liter
Standard Deviation 15.79
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 10, Week 8, n=151
|
0.0 International units per liter
Standard Deviation 11.05
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 10, Week 16, n=143
|
0.1 International units per liter
Standard Deviation 13.75
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 10, Week 24, n=145
|
0.1 International units per liter
Standard Deviation 13.80
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 10, Week 32, n=140
|
0.5 International units per liter
Standard Deviation 13.90
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 10, Week 40, n=137
|
-0.4 International units per liter
Standard Deviation 13.30
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 10, Week 48, n=135
|
0.9 International units per liter
Standard Deviation 14.71
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 11, Week 8, n=138
|
-0.2 International units per liter
Standard Deviation 12.04
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 11, Week 16, n=128
|
-0.1 International units per liter
Standard Deviation 12.72
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 11, Week 24, n=129
|
-0.3 International units per liter
Standard Deviation 12.69
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 11, Week 32, n=124
|
-1.0 International units per liter
Standard Deviation 10.03
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 11, Week 40, n=124
|
0.1 International units per liter
Standard Deviation 14.28
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 11, Week 48, n=107
|
1.3 International units per liter
Standard Deviation 17.70
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 12, Week 8, n=109
|
0.1 International units per liter
Standard Deviation 16.11
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 12, Week 16, n=97
|
-0.5 International units per liter
Standard Deviation 7.74
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 12, Week 24, n=85
|
1.0 International units per liter
Standard Deviation 13.58
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 12, Week 32, n=84
|
0.5 International units per liter
Standard Deviation 11.11
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 12, Week 40, n=82
|
0.2 International units per liter
Standard Deviation 11.60
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 12, Week 48, n=72
|
-1.0 International units per liter
Standard Deviation 12.48
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 13, Week 8, n=53
|
-2.5 International units per liter
Standard Deviation 10.00
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 13, Week 16, n=42
|
-3.4 International units per liter
Standard Deviation 14.32
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 13, Week 24, n=20
|
0.1 International units per liter
Standard Deviation 7.94
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 13, Week 32, n=7
|
0.3 International units per liter
Standard Deviation 4.96
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Year 13, Week 40, n=1
|
1.0 International units per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, Exit, n=248
|
-0.9 International units per liter
Standard Deviation 10.19
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, 8-Week Follow-up, n=220
|
-0.3 International units per liter
Standard Deviation 11.02
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
AST, 24-Week Follow-up , n=200
|
3.3 International units per liter
Standard Deviation 52.99
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 1, Week 8, n=284
|
0.6 International units per liter
Standard Deviation 23.57
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 1, Week 16, n=286
|
5.0 International units per liter
Standard Deviation 32.94
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 1, Week 24, n=292
|
6.3 International units per liter
Standard Deviation 48.10
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 1, Week 32, n=287
|
4.9 International units per liter
Standard Deviation 46.96
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 1, Week 40, n=284
|
6.7 International units per liter
Standard Deviation 55.51
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 1, Week 48, n=287
|
5.2 International units per liter
Standard Deviation 58.66
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 2, Week 8, n=288
|
4.6 International units per liter
Standard Deviation 50.82
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 2, Week 16, n=278
|
2.9 International units per liter
Standard Deviation 37.57
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 2, Week 24, n=273
|
4.5 International units per liter
Standard Deviation 42.01
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 2, Week 32, n=284
|
3.8 International units per liter
Standard Deviation 38.55
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 2, Week 40, n=264
|
4.2 International units per liter
Standard Deviation 41.34
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 2, Week 48, n=269
|
5.7 International units per liter
Standard Deviation 48.48
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 3, Week 8, n=265
|
3.9 International units per liter
Standard Deviation 33.83
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 3, Week 16, n=260
|
5.3 International units per liter
Standard Deviation 44.46
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 3, Week 24, n=244
|
4.0 International units per liter
Standard Deviation 51.58
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 3, Week 32, n=249
|
6.7 International units per liter
Standard Deviation 57.32
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 3, Week 40, n=245
|
3.7 International units per liter
Standard Deviation 29.97
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 3, Week 48, n=244
|
1.7 International units per liter
Standard Deviation 39.47
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 4, Week 8, n=239
|
3.1 International units per liter
Standard Deviation 53.57
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 4, Week 16, n=238
|
1.2 International units per liter
Standard Deviation 36.22
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 4, Week 24, n=226
|
3.0 International units per liter
Standard Deviation 55.72
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 4, Week 32, n=233
|
3.4 International units per liter
Standard Deviation 47.24
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 4, Week 40, n=220
|
2.0 International units per liter
Standard Deviation 40.20
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 4, Week 48, n=218
|
2.6 International units per liter
Standard Deviation 39.26
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 5, Week 8, n=218
|
4.8 International units per liter
Standard Deviation 40.08
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 5, Week 16, n=214
|
1.6 International units per liter
Standard Deviation 41.04
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 5, Week 24, n=211
|
3.0 International units per liter
Standard Deviation 39.90
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 5, Week 32, n=211
|
1.7 International units per liter
Standard Deviation 36.58
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 5, Week 40, n=198
|
1.4 International units per liter
Standard Deviation 41.74
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 5, Week 48, n=207
|
3.6 International units per liter
Standard Deviation 46.10
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 6, Week 8, n=206
|
1.9 International units per liter
Standard Deviation 48.45
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 6, Week 16, n=198
|
1.8 International units per liter
Standard Deviation 37.61
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 6, Week 24, n=190
|
1.6 International units per liter
Standard Deviation 43.58
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 6, Week 32, n=193
|
5.9 International units per liter
Standard Deviation 55.25
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 6, Week 40, n=185
|
2.0 International units per liter
Standard Deviation 34.66
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 6, Week 48, n=186
|
2.2 International units per liter
Standard Deviation 38.05
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 7, Week 8, n=179
|
2.3 International units per liter
Standard Deviation 36.39
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 7, Week 16, n=179
|
3.8 International units per liter
Standard Deviation 43.49
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 7, Week 24, n=173
|
4.5 International units per liter
Standard Deviation 33.15
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 7, Week 32, n=180
|
4.6 International units per liter
Standard Deviation 41.12
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 7, Week 40, n=175
|
4.9 International units per liter
Standard Deviation 36.94
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 7, Week 48, n=175
|
4.9 International units per liter
Standard Deviation 40.27
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 8, Week 8, n=171
|
7.0 International units per liter
Standard Deviation 41.53
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 8, Week 16, n=170
|
6.8 International units per liter
Standard Deviation 41.70
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 8, Week 24, n=168
|
8.5 International units per liter
Standard Deviation 48.16
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 8, Week 32, n=168
|
8.5 International units per liter
Standard Deviation 44.76
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 8, Week 40, n=162
|
3.5 International units per liter
Standard Deviation 38.79
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 8, Week 48, n=159
|
7.3 International units per liter
Standard Deviation 37.89
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 9, Week 8, n=164
|
7.1 International units per liter
Standard Deviation 39.19
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 9, Week 16, n=162
|
5.0 International units per liter
Standard Deviation 37.32
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 9, Week 24, n=161
|
2.6 International units per liter
Standard Deviation 33.54
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 9, Week 32, n=163
|
2.4 International units per liter
Standard Deviation 29.43
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 9, Week 40, n=156
|
2.9 International units per liter
Standard Deviation 32.70
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 9, Week 48, n=151
|
4.5 International units per liter
Standard Deviation 33.25
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 10, Week 8, n=152
|
2.7 International units per liter
Standard Deviation 28.57
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 10, Week 16, n=143
|
4.5 International units per liter
Standard Deviation 33.50
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 10, Week 24, n=145
|
3.0 International units per liter
Standard Deviation 31.51
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 10, Week 32, n=142
|
4.2 International units per liter
Standard Deviation 31.74
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 10, Week 40, n=138
|
2.9 International units per liter
Standard Deviation 31.64
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 10, Week 48, n=135
|
5.9 International units per liter
Standard Deviation 29.18
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 11, Week 8, n=138
|
3.8 International units per liter
Standard Deviation 33.68
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 11, Week 16, n=128
|
4.8 International units per liter
Standard Deviation 32.72
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 11, Week 24, n=130
|
3.4 International units per liter
Standard Deviation 26.42
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 11, Week 32, n=125
|
2.8 International units per liter
Standard Deviation 29.33
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 11, Week 40, n=124
|
2.5 International units per liter
Standard Deviation 28.02
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 11, Week 48, n=108
|
7.0 International units per liter
Standard Deviation 37.14
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 12, Week 8, n=110
|
7.9 International units per liter
Standard Deviation 37.22
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 12, Week 16, n=97
|
2.3 International units per liter
Standard Deviation 19.42
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 12, Week 24, n=87
|
5.2 International units per liter
Standard Deviation 32.26
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 12, Week 32, n=84
|
4.4 International units per liter
Standard Deviation 26.44
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 12, Week 40, n=82
|
2.0 International units per liter
Standard Deviation 27.54
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 12, Week 48, n=72
|
1.6 International units per liter
Standard Deviation 18.01
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 13, Week 8, n=53
|
2.4 International units per liter
Standard Deviation 18.65
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 13, Week 16, n=42
|
8.8 International units per liter
Standard Deviation 57.73
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 13, Week 24, n=20
|
10.5 International units per liter
Standard Deviation 40.97
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 13, Week 32, n=7
|
6.1 International units per liter
Standard Deviation 19.07
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Year 13, Week 40, n=1
|
3.0 International units per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, Exit, n=248
|
1.8 International units per liter
Standard Deviation 53.15
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, 8-Week Follow-up, n=220
|
3.3 International units per liter
Standard Deviation 24.91
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
GGT, 24-Week Follow-up , n=200
|
3.1 International units per liter
Standard Deviation 55.20
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 1, Week 8, n=281
|
-0.4 International units per liter
Standard Deviation 23.41
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 1, Week 16, n=283
|
-0.4 International units per liter
Standard Deviation 29.97
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 1, Week 24, n=287
|
-0.8 International units per liter
Standard Deviation 31.43
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 1, Week 32, n=283
|
-5.1 International units per liter
Standard Deviation 26.19
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 1, Week 40, n=282
|
-3.6 International units per liter
Standard Deviation 27.97
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 1, Week 48, n=284
|
-4.5 International units per liter
Standard Deviation 28.66
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 2, Week 8, n=288
|
-1.7 International units per liter
Standard Deviation 28.26
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 2, Week 16, n=275
|
-0.3 International units per liter
Standard Deviation 30.16
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 2, Week 24, n=269
|
-0.4 International units per liter
Standard Deviation 29.91
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 2, Week 32, n=284
|
-2.1 International units per liter
Standard Deviation 34.05
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 2, Week 40, n=261
|
-4.7 International units per liter
Standard Deviation 29.69
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 2, Week 48, n=267
|
-1.9 International units per liter
Standard Deviation 29.81
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 3, Week 8, n=262
|
-5.1 International units per liter
Standard Deviation 29.71
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 3, Week 16, n=258
|
-2.9 International units per liter
Standard Deviation 31.27
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 3, Week 24, n=241
|
1.0 International units per liter
Standard Deviation 32.12
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 3, Week 32, n=245
|
0.9 International units per liter
Standard Deviation 36.26
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 3, Week 40, n=242
|
1.3 International units per liter
Standard Deviation 34.00
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 3, Week 48, n=239
|
4.5 International units per liter
Standard Deviation 35.46
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 4, Week 8, n=237
|
3.9 International units per liter
Standard Deviation 36.59
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 4, Week 16, n=235
|
4.2 International units per liter
Standard Deviation 38.16
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 4, Week 24, n=225
|
3.8 International units per liter
Standard Deviation 38.59
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 4, Week 32, n=230
|
6.3 International units per liter
Standard Deviation 37.05
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 4, Week 40, n=218
|
2.0 International units per liter
Standard Deviation 37.75
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 4, Week 48, n=214
|
8.5 International units per liter
Standard Deviation 39.80
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 5, Week 8, n=217
|
6.7 International units per liter
Standard Deviation 39.42
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 5, Week 16, n=213
|
7.9 International units per liter
Standard Deviation 42.94
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 5, Week 24, n=206
|
7.6 International units per liter
Standard Deviation 40.54
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 5, Week 32, n=211
|
7.0 International units per liter
Standard Deviation 36.84
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 5, Week 40, n=196
|
5.0 International units per liter
Standard Deviation 40.29
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 5, Week 48, n=207
|
6.1 International units per liter
Standard Deviation 37.15
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 6, Week 8, n=205
|
8.4 International units per liter
Standard Deviation 36.82
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 6, Week 16, n=198
|
6.4 International units per liter
Standard Deviation 36.98
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 6, Week 24, n=189
|
5.2 International units per liter
Standard Deviation 38.41
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 6, Week 32, n=192
|
6.1 International units per liter
Standard Deviation 34.07
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 6, Week 40, n=181
|
6.0 International units per liter
Standard Deviation 39.60
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 6, Week 48, n=186
|
2.9 International units per liter
Standard Deviation 39.20
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 7, Week 8, n=177
|
4.8 International units per liter
Standard Deviation 37.46
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 7, Week 16, n=178
|
3.3 International units per liter
Standard Deviation 37.02
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 7, Week 24, n=171
|
8.9 International units per liter
Standard Deviation 39.81
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 7, Week 32, n=179
|
4.7 International units per liter
Standard Deviation 40.87
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 7, Week 40, n=172
|
6.8 International units per liter
Standard Deviation 39.49
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 7, Week 48, n=175
|
3.5 International units per liter
Standard Deviation 37.36
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 8, Week 8, n=170
|
3.0 International units per liter
Standard Deviation 36.88
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 8, Week 16, n=169
|
2.4 International units per liter
Standard Deviation 36.06
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 8, Week 24, n=167
|
2.4 International units per liter
Standard Deviation 37.06
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 8, Week 32, n=166
|
7.4 International units per liter
Standard Deviation 36.86
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 8, Week 40, n=161
|
2.1 International units per liter
Standard Deviation 35.04
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 8, Week 48, n=159
|
6.6 International units per liter
Standard Deviation 39.01
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 9, Week 8, n=163
|
4.5 International units per liter
Standard Deviation 36.82
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 9, Week 16, n=160
|
1.8 International units per liter
Standard Deviation 36.46
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 9, Week 24, n=160
|
3.9 International units per liter
Standard Deviation 35.65
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 9, Week 32, n=162
|
3.8 International units per liter
Standard Deviation 37.69
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 9, Week 40, n=156
|
7.5 International units per liter
Standard Deviation 39.97
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 9, Week 48, n=150
|
5.8 International units per liter
Standard Deviation 39.05
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 10, Week 8, n=151
|
4.5 International units per liter
Standard Deviation 42.02
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 10, Week 16, n=143
|
2.5 International units per liter
Standard Deviation 34.44
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 10, Week 24, n=145
|
2.1 International units per liter
Standard Deviation 38.80
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 10, Week 32, n=140
|
5.4 International units per liter
Standard Deviation 41.37
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 10, Week 40, n=137
|
7.6 International units per liter
Standard Deviation 37.07
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 10, Week 48, n=135
|
5.4 International units per liter
Standard Deviation 37.12
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 11, Week 8, n=138
|
6.1 International units per liter
Standard Deviation 45.90
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 11, Week 16, n=128
|
2.4 International units per liter
Standard Deviation 38.69
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 11, Week 24, n=129
|
5.5 International units per liter
Standard Deviation 42.10
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 11, Week 32, n=124
|
0.8 International units per liter
Standard Deviation 44.21
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 11, Week 40, n=124
|
2.1 International units per liter
Standard Deviation 41.89
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 11, Week 48, n=107
|
8.8 International units per liter
Standard Deviation 40.94
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 12, Week 8, n=109
|
5.9 International units per liter
Standard Deviation 51.46
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 12, Week 16, n=97
|
5.2 International units per liter
Standard Deviation 45.81
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 12, Week 24, n=85
|
6.6 International units per liter
Standard Deviation 47.18
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 12, Week 32, n=84
|
2.0 International units per liter
Standard Deviation 47.59
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 12, Week 40, n=82
|
2.2 International units per liter
Standard Deviation 47.71
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 12, Week 48, n=72
|
1.9 International units per liter
Standard Deviation 61.71
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 13, Week 8, n=53
|
-0.3 International units per liter
Standard Deviation 31.81
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 13, Week 16, n=42
|
-6.3 International units per liter
Standard Deviation 38.99
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 13, Week 24, n=20
|
0.3 International units per liter
Standard Deviation 51.57
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 13, Week 32, n=7
|
-27.3 International units per liter
Standard Deviation 63.45
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Year 13, Week 40, n=1
|
26.0 International units per liter
Standard Deviation NA
No value as only one participant was analyzed.
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, Exit, n=248
|
6.4 International units per liter
Standard Deviation 44.59
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, 8-Week Follow-up, n=220
|
7.7 International units per liter
Standard Deviation 51.21
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
LD, 24-Week Follow-up , n=200
|
6.5 International units per liter
Standard Deviation 49.90
|
SECONDARY outcome
Timeframe: Approximately up to 13 yearsPopulation: MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
SRI response was assessed at Week 16, 32, and 48 during Year 1 to 12 and Week 16 and 32 during Year 13. Baseline is defined as the last available value prior to belimumab start date, 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. SRI response is defined as:\>=4 point reduction from the Baseline in safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of \<0.30 points from the Baseline) in Physician's 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 Baseline at the time of assessment.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=296 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 1 , Week 16, n=268
|
32.8 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 1 , Week 32, n=269
|
41.6 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 1 , Week 48, n=266
|
47.0 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 2 , Week 16, n=266
|
50.8 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 2, Week 32, n=262
|
56.5 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 2, Week 48, n=251
|
57.0 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 3, Week 16, n=245
|
59.2 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 3, Week 32, n=235
|
54.5 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 3, Week 48, n=225
|
57.8 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 4, Week 16, n=225
|
56.9 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 4, Week 32, n=212
|
56.6 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 4, Week 48, n=206
|
59.7 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 5, Week 16, n=198
|
65.7 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 5, Week 32, n=194
|
64.4 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 5, Week 48, n=192
|
62.5 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 6, Week 16, n=182
|
64.8 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 6, Week 32, n=181
|
65.7 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 6, Week 48, n=176
|
63.6 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 7, Week 16, n=169
|
63.9 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 7, Week 32, n=173
|
69.4 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 7, Week 48, n=162
|
69.1 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 8, Week 16, n=161
|
68.3 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 8, Week 32, n=158
|
67.7 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 8, Week 48, n=149
|
62.4 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 9, Week 16, n=151
|
64.2 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 9, Week 32, n=148
|
66.2 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 9, Week 48, n=142
|
66.2 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 10, Week 16, n=141
|
66.0 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 10, Week 32, n=135
|
66.7 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 10, Week 48, n=126
|
65.1 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 11, Week 16, n=125
|
73.6 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 11, Week 32, n=120
|
64.2 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 11, Week 48, n=109
|
65.1 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 12, Week 16, n=100
|
69.0 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 12, Week 32, n=90
|
75.6 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 12, Week 48, n=71
|
71.8 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 13, Week 16, n=42
|
73.8 Percentage of participants
|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Year 13, Week 32, n=7
|
57.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Approximately up to 13 yearsPopulation: MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed.
Anti-double stranded DNA levels in participants positive at Baseline were assessed at Baseline, Week 16, 32, and 48 during Year 1 to 11, Week 16 and 32 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). The Baseline is defined as the last available value prior to belimumab start date, 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. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=149 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Baseline, n=149
|
147.00 International units (IU)/milliliter (mL)
Interval 31.0 to 418.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 1 , Week 16, n=147
|
114.00 International units (IU)/milliliter (mL)
Interval 6.0 to 418.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 1 , Week 32, n=147
|
113.00 International units (IU)/milliliter (mL)
Interval 5.0 to 349.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 1 , Week 48, n=144
|
106.50 International units (IU)/milliliter (mL)
Interval 5.0 to 464.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 2 , Week 16, n=144
|
93.50 International units (IU)/milliliter (mL)
Interval 3.0 to 328.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 2, Week 32, n=143
|
85.00 International units (IU)/milliliter (mL)
Interval 5.0 to 271.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 2, Week 48, n=128
|
83.50 International units (IU)/milliliter (mL)
Interval 5.0 to 271.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 3, Week 16, n=134
|
83.50 International units (IU)/milliliter (mL)
Interval 5.0 to 271.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 3, Week 32, n=127
|
76.00 International units (IU)/milliliter (mL)
Interval 5.0 to 271.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 3, Week 48, n=125
|
73.00 International units (IU)/milliliter (mL)
Interval 5.0 to 271.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 4, Week 16, n=124
|
80.00 International units (IU)/milliliter (mL)
Interval 5.0 to 271.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 4, Week 32, n=120
|
72.00 International units (IU)/milliliter (mL)
Interval 5.0 to 271.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 4, Week 48, n=116
|
66.50 International units (IU)/milliliter (mL)
Interval 5.0 to 271.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 5, Week 16, n=112
|
54.00 International units (IU)/milliliter (mL)
Interval 5.0 to 271.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 5, Week 32, n=111
|
61.00 International units (IU)/milliliter (mL)
Interval 5.0 to 271.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 5, Week 48, n=108
|
49.50 International units (IU)/milliliter (mL)
Interval 5.0 to 271.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 6, Week 16, n=105
|
41.00 International units (IU)/milliliter (mL)
Interval 5.0 to 271.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 6, Week 32, n=101
|
44.00 International units (IU)/milliliter (mL)
Interval 5.0 to 271.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 6, Week 48, n=99
|
36.00 International units (IU)/milliliter (mL)
Interval 5.0 to 271.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 7, Week 16, n=89
|
41.00 International units (IU)/milliliter (mL)
Interval 5.0 to 271.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 7, Week 32, n=94
|
36.50 International units (IU)/milliliter (mL)
Interval 5.0 to 271.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 7, Week 48, n=89
|
38.00 International units (IU)/milliliter (mL)
Interval 5.0 to 586.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 8, Week 16, n=87
|
30.00 International units (IU)/milliliter (mL)
Interval 5.0 to 468.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 8, Week 32, n=89
|
43.00 International units (IU)/milliliter (mL)
Interval 5.0 to 890.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 8, Week 48, n=80
|
27.50 International units (IU)/milliliter (mL)
Interval 5.0 to 1826.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 9, Week 16, n=85
|
32.00 International units (IU)/milliliter (mL)
Interval 5.0 to 745.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 9, Week 32, n=83
|
20.00 International units (IU)/milliliter (mL)
Interval 5.0 to 2120.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 9, Week 48, n=77
|
16.00 International units (IU)/milliliter (mL)
Interval 5.0 to 423.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 10, Week 16, n=77
|
18.00 International units (IU)/milliliter (mL)
Interval 5.0 to 593.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 10, Week 32, n=75
|
22.00 International units (IU)/milliliter (mL)
Interval 5.0 to 607.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 10, Week 48, n=71
|
18.00 International units (IU)/milliliter (mL)
Interval 5.0 to 500.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 11, Week 16, n=67
|
17.00 International units (IU)/milliliter (mL)
Interval 5.0 to 445.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 11, Week 32, n=66
|
15.00 International units (IU)/milliliter (mL)
Interval 5.0 to 611.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 11, Week 48, n=63
|
11.00 International units (IU)/milliliter (mL)
Interval 5.0 to 546.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 12, Week 16, n=54
|
11.00 International units (IU)/milliliter (mL)
Interval 5.0 to 330.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 12, Week 32, n=47
|
8.00 International units (IU)/milliliter (mL)
Interval 5.0 to 219.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 12, Week 48, n=39
|
14.00 International units (IU)/milliliter (mL)
Interval 5.0 to 402.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 13, Week 16, n=20
|
13.50 International units (IU)/milliliter (mL)
Interval 5.0 to 549.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Year 13, Week 32, n=3
|
7.00 International units (IU)/milliliter (mL)
Interval 5.0 to 8.0
|
|
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Exit, n=124
|
31.00 International units (IU)/milliliter (mL)
Interval 5.0 to 1073.0
|
SECONDARY outcome
Timeframe: Baseline and approximately up to 13 yearsPopulation: MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed.
Anti-double stranded DNA levels for participants positive at Baseline were assessed at Baseline, Week 16, 32, and 48 during Year 1 to 11, Week 16 and 32 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). The Baseline is defined as the last available value prior to belimumab start date, 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. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=149 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 7, Week 32, n=94
|
-68.93 Percent change
Interval -96.7 to 243.0
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 7, Week 48, n=89
|
-68.63 Percent change
Interval -98.1 to 182.3
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 1 , Week 16, n=147
|
-16.26 Percent change
Interval -87.5 to 252.1
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 1 , Week 32, n=147
|
-25.57 Percent change
Interval -93.8 to 168.8
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 1 , Week 48, n=144
|
-30.17 Percent change
Interval -93.4 to 177.1
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 2 , Week 16, n=144
|
-30.26 Percent change
Interval -96.3 to 344.3
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 2, Week 32, n=143
|
-31.25 Percent change
Interval -90.0 to 224.6
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 2, Week 48, n=128
|
-41.63 Percent change
Interval -93.8 to 133.6
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 3, Week 16, n=134
|
-41.10 Percent change
Interval -94.1 to 232.4
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 3, Week 32, n=127
|
-44.44 Percent change
Interval -94.8 to 208.3
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 3, Week 48, n=125
|
-45.29 Percent change
Interval -95.4 to 133.6
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 4, Week 16, n=124
|
-47.33 Percent change
Interval -95.2 to 243.0
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 4, Week 32, n=120
|
-48.53 Percent change
Interval -95.4 to 243.0
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 4, Week 48, n=116
|
-48.45 Percent change
Interval -96.7 to 243.0
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 5, Week 16, n=112
|
-53.97 Percent change
Interval -96.1 to 243.0
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 5, Week 32, n=111
|
-47.27 Percent change
Interval -96.7 to 411.3
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 5, Week 48, n=108
|
-57.76 Percent change
Interval -96.7 to 453.1
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 6, Week 16, n=105
|
-60.00 Percent change
Interval -97.4 to 361.2
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 6, Week 32, n=101
|
-65.38 Percent change
Interval -96.8 to 411.3
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 6, Week 48, n=99
|
-66.42 Percent change
Interval -97.7 to 243.0
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 7, Week 16, n=89
|
-64.14 Percent change
Interval -97.2 to 243.0
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 8, Week 16, n=87
|
-73.77 Percent change
Interval -98.1 to 111.7
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 8, Week 32, n=89
|
-71.02 Percent change
Interval -98.3 to 249.0
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 8, Week 48, n=80
|
-76.62 Percent change
Interval -98.1 to 1326.6
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 9, Week 16, n=85
|
-75.00 Percent change
Interval -97.4 to 1452.1
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 9, Week 32, n=83
|
-80.13 Percent change
Interval -98.1 to 4316.7
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 9, Week 48, n=77
|
-81.38 Percent change
Interval -97.7 to 152.1
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 10, Week 16, n=77
|
-81.25 Percent change
Interval -97.4 to 363.3
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 10, Week 32, n=75
|
-78.11 Percent change
Interval -98.1 to 175.0
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 10, Week 48, n=71
|
-81.13 Percent change
Interval -98.4 to 124.2
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 11, Week 16, n=67
|
-82.86 Percent change
Interval -98.4 to 99.6
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 11, Week 32, n=66
|
-85.39 Percent change
Interval -97.7 to 377.3
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 11, Week 48, n=63
|
-85.29 Percent change
Interval -98.4 to 326.6
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 12, Week 16, n=54
|
-85.39 Percent change
Interval -97.8 to 132.8
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 12, Week 32, n=47
|
-88.52 Percent change
Interval -98.4 to 71.1
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 12, Week 48, n=39
|
-87.76 Percent change
Interval -98.4 to 135.2
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 13, Week 16, n=20
|
-86.87 Percent change
Interval -98.4 to 192.0
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Year 13, Week 32, n=3
|
-91.49 Percent change
Interval -98.4 to -86.8
|
|
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Exit, n=124
|
-75.68 Percent change
Interval -98.4 to 257.7
|
SECONDARY outcome
Timeframe: Approximately up to 13 yearsPopulation: MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed.
Complement C3 and C4 levels were assessed in participants low at Baseline at Baseline, Week 16, 32, and 48 during Year 1 to 12, Week 16 and 32 during Year 13, and Exit visit. The Baseline is defined as the last available value prior to belimumab start date, 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. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=88 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Baseline, n=88
|
0.77 grams per liter
Interval 0.4 to 0.9
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 1, Week 16, n=86
|
0.81 grams per liter
Interval 0.5 to 1.3
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 1, Week 32, n=88
|
0.81 grams per liter
Interval 0.2 to 1.5
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 1, Week 48, n=86
|
0.82 grams per liter
Interval 0.5 to 1.3
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 2, Week 16, n=83
|
0.82 grams per liter
Interval 0.6 to 1.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 2, Week 32, n=83
|
0.84 grams per liter
Interval 0.5 to 1.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 2, Week 48, n=76
|
0.88 grams per liter
Interval 0.5 to 1.3
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 3, Week 16, n=75
|
0.88 grams per liter
Interval 0.3 to 1.3
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 3, Week 32, n=75
|
0.90 grams per liter
Interval 0.5 to 1.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 3, Week 48, n=73
|
0.90 grams per liter
Interval 0.3 to 1.5
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 4, Week 16, n=74
|
0.93 grams per liter
Interval 0.5 to 1.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 4, Week 32, n=72
|
0.96 grams per liter
Interval 0.4 to 1.3
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 4, Week 48, n=67
|
0.93 grams per liter
Interval 0.5 to 1.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 5, Week 16, n=65
|
0.94 grams per liter
Interval 0.4 to 1.5
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 5, Week 32, n=65
|
0.97 grams per liter
Interval 0.4 to 1.5
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 5, Week 48, n=65
|
1.01 grams per liter
Interval 0.4 to 1.5
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 6, Week 16, n=61
|
1.02 grams per liter
Interval 0.4 to 1.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 6, Week 32, n=59
|
1.03 grams per liter
Interval 0.5 to 1.5
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 6, Week 48, n=57
|
1.00 grams per liter
Interval 0.4 to 1.5
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 7, Week 16, n=50
|
0.94 grams per liter
Interval 0.5 to 1.6
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 7, Week 32, n=54
|
0.99 grams per liter
Interval 0.2 to 1.5
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 7, Week 48, n=52
|
0.98 grams per liter
Interval 0.3 to 1.7
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 8, Week 16, n=46
|
0.98 grams per liter
Interval 0.3 to 1.6
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 8, Week 32, n=48
|
1.01 grams per liter
Interval 0.5 to 1.6
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 8, Week 48, n=45
|
1.01 grams per liter
Interval 0.6 to 2.0
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 9, Week 16, n=49
|
1.02 grams per liter
Interval 0.5 to 2.1
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 9, Week 32, n=46
|
0.95 grams per liter
Interval 0.5 to 2.0
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 9, Week 48, n=47
|
0.98 grams per liter
Interval 0.5 to 1.9
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 10, Week 16, n=43
|
0.91 grams per liter
Interval 0.4 to 1.6
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 10, Week 32, n=45
|
0.99 grams per liter
Interval 0.3 to 2.0
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 10, Week 48, n=44
|
0.90 grams per liter
Interval 0.5 to 1.9
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 11, Week 16, n=43
|
0.97 grams per liter
Interval 0.4 to 1.7
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 11, Week 32, n=42
|
0.99 grams per liter
Interval 0.6 to 1.9
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 11, Week 48, n=37
|
0.88 grams per liter
Interval 0.5 to 1.7
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 12, Week 16, n=31
|
0.92 grams per liter
Interval 0.5 to 1.9
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 12, Week 32, n=28
|
0.94 grams per liter
Interval 0.5 to 1.7
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 12, Week 48, n=28
|
0.84 grams per liter
Interval 0.4 to 1.6
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 13, Week 16, n=12
|
0.95 grams per liter
Interval 0.6 to 1.6
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 13, Week 32, n=2
|
0.99 grams per liter
Interval 0.8 to 1.2
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Exit, n=74
|
0.98 grams per liter
Interval 0.4 to 1.6
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Baseline, n=116
|
0.10 grams per liter
Interval 0.0 to 0.2
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 1, Week 16, n=112
|
0.12 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 1, Week 32, n=113
|
0.13 grams per liter
Interval 0.0 to 0.3
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 1, Week 48, n=112
|
0.14 grams per liter
Interval 0.0 to 0.3
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 2, Week 16, n=110
|
0.15 grams per liter
Interval 0.0 to 0.3
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 2, Week 32, n=110
|
0.15 grams per liter
Interval 0.0 to 0.3
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 2, Week 48, n=103
|
0.17 grams per liter
Interval 0.0 to 0.5
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 3, Week 16, n=101
|
0.16 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 3, Week 32, n=100
|
0.17 grams per liter
Interval 0.0 to 0.5
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 3, Week 48, n=97
|
0.17 grams per liter
Interval 0.0 to 0.5
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 4, Week 16, n=97
|
0.17 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 4, Week 32, n=93
|
0.17 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 4, Week 48, n=90
|
0.18 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 5, Week 16, n=83
|
0.18 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 5, Week 32, n=81
|
0.19 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 5, Week 48, n=81
|
0.19 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 6, Week 16, n=78
|
0.20 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 6, Week 32, n=74
|
0.19 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 6, Week 48, n=71
|
0.19 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 7, Week 16, n=66
|
0.19 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 7, Week 32, n=67
|
0.20 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 7, Week 48, n=65
|
0.20 grams per liter
Interval 0.0 to 0.5
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 8, Week 16, n=61
|
0.20 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 8, Week 32, n=62
|
0.20 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 8, Week 48, n=56
|
0.20 grams per liter
Interval 0.1 to 0.6
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 9, Week 16, n=62
|
0.20 grams per liter
Interval 0.0 to 0.5
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 9, Week 32, n=59
|
0.19 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 9, Week 48, n=55
|
0.19 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 10, Week 16, n=54
|
0.2 grams per liter
Interval 0.1 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 10, Week 32, n=52
|
0.19 grams per liter
Interval 0.0 to 0.5
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 10, Week 48, n=51
|
0.18 grams per liter
Interval 0.0 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 11, Week 16, n=50
|
0.2 grams per liter
Interval 0.1 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 11, Week 32, n=48
|
0.20 grams per liter
Interval 0.1 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 11, Week 48, n=44
|
0.21 grams per liter
Interval 0.1 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 12, Week 16, n=41
|
0.18 grams per liter
Interval 0.1 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 12, Week 32, n=37
|
0.21 grams per liter
Interval 0.1 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 12, Week 48, n=31
|
0.18 grams per liter
Interval 0.1 to 0.3
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 13, Week 16, n=16
|
0.21 grams per liter
Interval 0.1 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 13, Week 32, n=3
|
0.29 grams per liter
Interval 0.2 to 0.4
|
|
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Exit, n=93
|
0.18 grams per liter
Interval 0.0 to 0.4
|
SECONDARY outcome
Timeframe: Baseline and approximately up to 13 yearsPopulation: MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed.
Complement C3 and C4 levels were assessed in participants low at Baseline at Baseline, Week 16, 32, and 48 during Year 1 to 12, Week 16 and 32 during Year 13, and Exit visit. The Baseline is defined as the last available value prior to belimumab start date, 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. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=88 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 1, Week 16, n=86
|
8.87 Percent change
Interval -32.1 to 72.1
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 1, Week 32, n=88
|
8.43 Percent change
Interval -68.0 to 68.5
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 1, Week 48, n=86
|
11.71 Percent change
Interval -33.3 to 56.5
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 2, Week 16, n=83
|
13.10 Percent change
Interval -29.5 to 83.8
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 2, Week 32, n=83
|
13.21 Percent change
Interval -19.5 to 135.3
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 2, Week 48, n=76
|
17.16 Percent change
Interval -25.0 to 74.6
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 3, Week 16, n=75
|
15.48 Percent change
Interval -50.8 to 129.4
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 3, Week 32, n=75
|
19.05 Percent change
Interval -42.4 to 176.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 3, Week 48, n=73
|
16.46 Percent change
Interval -61.7 to 182.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 4, Week 16, n=74
|
22.51 Percent change
Interval -34.2 to 178.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 4, Week 32, n=72
|
30.41 Percent change
Interval -56.8 to 158.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 4, Week 48, n=67
|
26.58 Percent change
Interval -34.1 to 148.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 5, Week 16, n=65
|
27.38 Percent change
Interval -47.7 to 156.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 5, Week 32, n=65
|
23.17 Percent change
Interval -39.5 to 148.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 5, Week 48, n=65
|
35.96 Percent change
Interval -26.2 to 129.4
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 6, Week 16, n=61
|
29.41 Percent change
Interval -20.8 to 158.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 6, Week 32, n=59
|
31.03 Percent change
Interval -21.7 to 138.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 6, Week 48, n=57
|
28.24 Percent change
Interval -36.7 to 151.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 7, Week 16, n=50
|
20.95 Percent change
Interval -32.5 to 149.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 7, Week 32, n=54
|
29.25 Percent change
Interval -63.8 to 168.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 7, Week 48, n=52
|
39.88 Percent change
Interval -51.7 to 186.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 8, Week 16, n=46
|
28.35 Percent change
Interval -62.5 to 167.3
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 8, Week 32, n=48
|
30.88 Percent change
Interval -34.2 to 138.8
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 8, Week 48, n=45
|
32.88 Percent change
Interval -34.5 to 200.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 9, Week 16, n=49
|
36.99 Percent change
Interval -45.9 to 208.8
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 9, Week 32, n=46
|
21.76 Percent change
Interval -26.1 to 186.8
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 9, Week 48, n=47
|
23.29 Percent change
Interval -34.1 to 180.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 10, Week 16, n=43
|
22.35 Percent change
Interval -35.6 to 206.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 10, Week 32, n=45
|
23.81 Percent change
Interval -60.7 to 186.8
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 10, Week 48, n=44
|
26.90 Percent change
Interval -38.6 to 172.1
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 11, Week 16, n=43
|
26.97 Percent change
Interval -48.5 to 146.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 11, Week 32, n=42
|
30.36 Percent change
Interval -36.4 to 148.7
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 11, Week 48, n=37
|
20.78 Percent change
Interval -39.0 to 149.3
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 12, Week 16, n=31
|
15.58 Percent change
Interval -43.2 to 181.2
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 12, Week 32, n=28
|
26.39 Percent change
Interval -39.5 to 123.7
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 12, Week 48, n=28
|
14.1 Percent change
Interval -58.0 to 114.5
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 13, Week 16, n=12
|
35.33 Percent change
Interval -8.3 to 97.2
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Year 13, Week 32, n=2
|
22.04 Percent change
Interval 9.6 to 34.5
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C3, Exit, n=74
|
29.19 Percent change
Interval -48.8 to 152.6
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 1, Week 16, n=112
|
25.00 Percent change
Interval -57.1 to 200.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 1, Week 32, n=113
|
33.33 Percent change
Interval -70.0 to 180.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 1, Week 48, n=112
|
34.52 Percent change
Interval -60.0 to 183.3
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 2, Week 16, n=110
|
50.00 Percent change
Interval -70.0 to 300.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 2, Week 32, n=110
|
53.33 Percent change
Interval -25.0 to 400.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 2, Week 48, n=103
|
53.85 Percent change
Interval -12.5 to 308.3
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 3, Week 16, n=101
|
53.33 Percent change
Interval -33.3 to 275.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 3, Week 32, n=100
|
63.39 Percent change
Interval -58.3 to 400.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 3, Week 48, n=97
|
53.33 Percent change
Interval -66.7 to 422.2
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 4, Week 16, n=97
|
70.00 Percent change
Interval -70.0 to 400.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 4, Week 32, n=93
|
69.23 Percent change
Interval -50.0 to 350.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 4, Week 48, n=90
|
66.67 Percent change
Interval -37.5 to 420.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 5, Week 16, n=83
|
71.43 Percent change
Interval -33.3 to 500.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 5, Week 32, n=81
|
66.67 Percent change
Interval -33.3 to 425.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 5, Week 48, n=81
|
80.00 Percent change
Interval -66.7 to 460.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 6, Week 16, n=78
|
70.33 Percent change
Interval -12.5 to 380.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 6, Week 32, n=74
|
85.71 Percent change
Interval -12.5 to 400.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 6, Week 48, n=71
|
100.0 Percent change
Interval -25.0 to 450.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 7, Week 16, n=66
|
79.29 Percent change
Interval -13.3 to 350.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 7, Week 32, n=67
|
85.71 Percent change
Interval -25.0 to 440.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 7, Week 48, n=65
|
100.0 Percent change
Interval -50.0 to 377.8
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 8, Week 16, n=61
|
90.00 Percent change
Interval -15.4 to 433.3
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 8, Week 32, n=62
|
81.67 Percent change
Interval -18.2 to 575.5
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 8, Week 48, n=56
|
76.36 Percent change
Interval -8.3 to 866.7
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 9, Week 16, n=62
|
87.86 Percent change
Interval -57.1 to 566.7
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 9, Week 32, n=59
|
72.73 Percent change
Interval -33.3 to 533.3
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 9, Week 48, n=55
|
71.43 Percent change
Interval -42.9 to 566.7
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 10, Week 16, n=54
|
81.82 Percent change
Interval -33.3 to 625.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 10, Week 32, n=52
|
84.52 Percent change
Interval -57.1 to 575.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 10, Week 48, n=51
|
73.33 Percent change
Interval -57.1 to 575.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 11, Week 16, n=50
|
75.71 Percent change
Interval -27.3 to 500.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 11, Week 32, n=48
|
81.67 Percent change
Interval -20.0 to 475.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 11, Week 48, n=44
|
103.33 Percent change
Interval -33.3 to 650.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 12, Week 16, n=41
|
75.0 Percent change
Interval -20.0 to 525.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 12, Week 32, n=37
|
100.0 Percent change
Interval -23.1 to 340.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 12, Week 48, n=31
|
80.0 Percent change
Interval -18.2 to 475.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 13, Week 16, n=16
|
135.0 Percent change
Interval 0.0 to 400.0
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Year 13, Week 32, n=3
|
190.0 Percent change
Interval 33.3 to 258.3
|
|
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
C4, Exit, n=93
|
78.57 Percent change
Interval -57.1 to 575.0
|
SECONDARY outcome
Timeframe: Approximately up to 13 yearsPopulation: MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Daily prednisone dose reduction was assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13. Percentage of participants with daily prednisone dose reduced to \<=7.5 mg/day from \>7.5 mg/kg at the Baseline are summarized. Baseline is defined as the last available value prior to belimumab start date, 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.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=92 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 1, Week 8, n=91
|
0 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 1, Week 16, n=90
|
5.6 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 1, Week 24, n=91
|
19.8 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 1, Week 32, n=91
|
19.8 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 1, Week 40, n=87
|
23.0 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 1, Week 48, n=88
|
27.3 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 2, Week 8, n=90
|
28.9 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 2, Week 16, n=89
|
31.5 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 2, Week 24, n=90
|
28.9 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 2, Week 32, n=88
|
34.1 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 2, Week 40, n=84
|
35.7 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 2, Week 48, n=83
|
34.9 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 3, Week 8, n=81
|
35.8 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 3, Week 16, n=81
|
34.6 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 3, Week 24, n=73
|
34.2 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 3, Week 32, n=77
|
36.4 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 3, Week 40, n=78
|
33.3 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 3, Week 48, n=75
|
30.7 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 4, Week 8, n=72
|
40.3 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 4, Week 16, n=74
|
41.9 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 4, Week 24, n=71
|
45.1 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 4, Week 32, n=69
|
37.7 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 4, Week 40, n=67
|
37.3 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 4, Week 48, n=68
|
38.2 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 5, Week 8, n=67
|
41.8 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 5, Week 16, n=63
|
42.9 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 5, Week 24, n=64
|
45.3 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 5, Week 32, n=65
|
38.5 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 5, Week 40, n=58
|
48.3 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 5, Week 48, n=60
|
41.7 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 6, Week 8, n=61
|
44.3 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 6, Week 16, n=57
|
43.9 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 6, Week 24, n=58
|
48.3 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 6, Week 32, n=59
|
44.1 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 6, Week 40, n=55
|
41.8 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 6, Week 48, n=55
|
38.2 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 7, Week 8, n=52
|
46.2 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 7, Week 16, n=51
|
39.2 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 7, Week 24, n=51
|
41.2 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 7, Week 32, n=51
|
39.2 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 7, Week 40, n=51
|
39.2 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 7, Week 48, n=51
|
39.2 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 8, Week 8, n=50
|
40.0 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 8, Week 16, n=49
|
38.8 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 8, Week 24, n=50
|
38.0 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 8, Week 32, n=49
|
36.7 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 8, Week 40, n=49
|
38.8 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 8, Week 48, n=48
|
41.7 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 9, Week 8, n=48
|
39.6 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 9, Week 16, n=49
|
38.8 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 9, Week 24, n=49
|
38.8 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 9, Week 32, n=48
|
39.6 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 9, Week 40, n=48
|
35.4 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 9, Week 48, n=45
|
37.8 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 10, Week 8, n=46
|
37.0 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 10, Week 16, n=43
|
39.5 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 10, Week 24, n=44
|
31.8 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 10, Week 32, n=44
|
31.8 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 10, Week 40, n=43
|
34.9 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 10, Week 48, n=43
|
32.6 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 11, Week 8, n=44
|
36.4 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 11, Week 16, n=41
|
34.1 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 11, Week 24, n=40
|
32.5 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 11, Week 32, n=39
|
35.9 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 11, Week 40, n=40
|
40.0 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 11, Week 48, n=35
|
34.3 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 12, Week 8, n=35
|
34.3 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 12, Week 16, n=32
|
31.3 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 12, Week 24, n=29
|
34.5 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 12, Week 32, n=30
|
40.0 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 12, Week 40, n=30
|
46.7 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 12, Week 48, n=26
|
53.8 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 13, Week 8, n=19
|
47.4 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 13, Week 16, n=13
|
38.5 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 13, Week 24, n=6
|
50.0 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 13, Week 32, n=2
|
50.0 Percentage of participants
|
|
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Year 13, Week 40, n=1
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Approximately up to 13 yearsPopulation: MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Serum immunoglobulin G values were assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Baseline is defined as the last available value prior to belimumab start date, 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. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=296 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Baseline, n=293
|
12.90 grams per liter
Interval 3.3 to 39.5
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 1, Week 8, n=288
|
12.10 grams per liter
Interval 3.4 to 38.1
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 1, Week 16, n=292
|
11.70 grams per liter
Interval 3.3 to 34.3
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 1, Week 24, n=293
|
11.60 grams per liter
Interval 3.6 to 48.5
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 1, Week 32, n=291
|
11.50 grams per liter
Interval 3.8 to 32.6
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 1, Week 40, n=288
|
11.40 grams per liter
Interval 3.5 to 34.6
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 1, Week 48, n=289
|
11.50 grams per liter
Interval 3.5 to 33.8
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 2, Week 8, n=286
|
11.20 grams per liter
Interval 3.8 to 42.0
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 2, Week 16, n=284
|
11.30 grams per liter
Interval 3.2 to 41.7
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 2, Week 24, n=288
|
11.55 grams per liter
Interval 3.4 to 35.6
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 2, Week 32, n=284
|
11.40 grams per liter
Interval 3.2 to 32.2
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 2, Week 40, n=269
|
11.30 grams per liter
Interval 4.0 to 23.8
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 2, Week 48, n=269
|
11.30 grams per liter
Interval 3.1 to 24.5
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 3, Week 8, n=265
|
11.40 grams per liter
Interval 2.8 to 24.9
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 3, Week 16, n=260
|
11.45 grams per liter
Interval 3.2 to 27.2
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 3, Week 24, n=244
|
11.15 grams per liter
Interval 3.5 to 30.9
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 3, Week 32, n=250
|
11.40 grams per liter
Interval 3.2 to 27.0
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 3, Week 40, n=246
|
11.70 grams per liter
Interval 2.8 to 25.8
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 3, Week 48, n=244
|
11.70 grams per liter
Interval 3.3 to 28.3
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 4, Week 8, n=240
|
11.50 grams per liter
Interval 3.0 to 26.9
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 4, Week 16, n=240
|
11.60 grams per liter
Interval 3.0 to 28.5
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 4, Week 24, n=228
|
11.35 grams per liter
Interval 3.0 to 26.3
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 4, Week 32, n=233
|
11.20 grams per liter
Interval 3.0 to 24.0
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 4, Week 40, n=220
|
11.40 grams per liter
Interval 3.0 to 24.6
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 4, Week 48, n=222
|
11.35 grams per liter
Interval 3.0 to 26.8
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 5, Week 8, n=218
|
11.45 grams per liter
Interval 2.5 to 28.1
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 5, Week 16, n=215
|
11.00 grams per liter
Interval 2.8 to 26.7
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 5, Week 24, n=212
|
10.80 grams per liter
Interval 2.3 to 29.2
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 5, Week 32, n=211
|
11.00 grams per liter
Interval 2.8 to 27.1
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 5, Week 40, n=199
|
11.10 grams per liter
Interval 2.6 to 31.3
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 5, Week 48, n=209
|
10.80 grams per liter
Interval 2.7 to 28.2
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 6, Week 8, n=207
|
10.80 grams per liter
Interval 2.9 to 25.0
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 6, Week 16, n=199
|
10.30 grams per liter
Interval 2.7 to 23.6
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 6, Week 24, n=192
|
10.20 grams per liter
Interval 2.7 to 26.7
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 6, Week 32, n=197
|
10.30 grams per liter
Interval 2.7 to 24.9
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 6, Week 40, n=186
|
10.30 grams per liter
Interval 2.4 to 24.4
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 6, Week 48, n=188
|
9.78 grams per liter
Interval 2.1 to 23.7
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 7, Week 8, n=183
|
10.10 grams per liter
Interval 2.2 to 19.5
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 7, Week 16, n=182
|
10.15 grams per liter
Interval 2.0 to 24.6
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 7, Week 24, n=176
|
10.10 grams per liter
Interval 2.1 to 26.3
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 7, Week 32, n=182
|
9.98 grams per liter
Interval 2.0 to 23.4
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 7, Week 40, n=177
|
9.85 grams per liter
Interval 1.7 to 23.2
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 7, Week 48, n=177
|
9.64 grams per liter
Interval 1.7 to 22.6
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 8, Week 8, n=173
|
9.64 grams per liter
Interval 2.6 to 26.3
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 8, Week 16, n=172
|
9.40 grams per liter
Interval 2.0 to 22.7
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 8, Week 24, n=169
|
9.67 grams per liter
Interval 3.5 to 23.6
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 8, Week 32, n=170
|
9.72 grams per liter
Interval 2.9 to 18.8
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 8, Week 40, n=163
|
9.41 grams per liter
Interval 2.2 to 22.6
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 8, Week 48, n=161
|
9.42 grams per liter
Interval 2.3 to 22.4
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 9, Week 8, n=167
|
9.41 grams per liter
Interval 2.0 to 24.6
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 9, Week 16, n=163
|
9.24 grams per liter
Interval 4.0 to 21.7
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 9, Week 24, n=163
|
9.39 grams per liter
Interval 1.6 to 25.6
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 9, Week 32, n=164
|
9.25 grams per liter
Interval 2.0 to 24.2
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 9, Week 40, n=159
|
9.06 grams per liter
Interval 2.8 to 24.5
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 9, Week 48, n=151
|
9.01 grams per liter
Interval 3.0 to 23.9
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 10, Week 8, n=153
|
9.02 grams per liter
Interval 3.2 to 25.4
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 10, Week 16, n=146
|
8.96 grams per liter
Interval 2.7 to 27.3
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 10, Week 24, n=146
|
8.98 grams per liter
Interval 2.7 to 26.6
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 10, Week 32, n=142
|
8.97 grams per liter
Interval 2.4 to 23.1
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 10, Week 40, n=138
|
9.09 grams per liter
Interval 0.3 to 25.7
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 10, Week 48, n=137
|
9.25 grams per liter
Interval 2.6 to 26.3
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 11, Week 8, n=139
|
9.54 grams per liter
Interval 2.3 to 24.1
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 11, Week 16, n=129
|
9.36 grams per liter
Interval 2.5 to 15.3
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 11, Week 24, n=131
|
9.53 grams per liter
Interval 2.5 to 23.9
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 11, Week 32, n=128
|
9.46 grams per liter
Interval 2.5 to 23.0
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 11, Week 40, n=124
|
9.68 grams per liter
Interval 2.3 to 16.9
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 11, Week 48, n=108
|
9.41 grams per liter
Interval 2.6 to 16.8
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 12, Week 8, n=111
|
8.92 grams per liter
Interval 2.4 to 18.9
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 12, Week 16, n=99
|
9.55 grams per liter
Interval 2.2 to 17.0
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 12, Week 24, n=87
|
9.33 grams per liter
Interval 3.0 to 17.0
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 12, Week 32, n=88
|
9.19 grams per liter
Interval 2.1 to 17.1
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 12, Week 40, n=84
|
8.79 grams per liter
Interval 1.1 to 16.0
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 12, Week 48, n=73
|
9.39 grams per liter
Interval 3.2 to 15.6
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 13, Week 8, n=53
|
9.62 grams per liter
Interval 2.6 to 15.6
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 13, Week 16, n=43
|
9.40 grams per liter
Interval 2.6 to 16.4
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 13, Week 24, n=20
|
9.77 grams per liter
Interval 2.7 to 14.6
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 13, Week 32, n=7
|
10.60 grams per liter
Interval 6.8 to 11.2
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Year 13, Week 40, n=1
|
11.50 grams per liter
Interval 11.5 to 11.5
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Exit, n=248
|
9.62 grams per liter
Interval 1.8 to 23.5
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
8-Week follow-up, n=222
|
9.88 grams per liter
Interval 1.8 to 30.3
|
|
Absolute Serum Immunoglobulin G Values at Indicated Time Points
24-Week follow-up, n=200
|
9.89 grams per liter
Interval 1.3 to 29.1
|
SECONDARY outcome
Timeframe: Baseline and approximately up to 13 yearsPopulation: MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Serum immunoglobulin G values were assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Baseline is defined as the last available value prior to belimumab start date, 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. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.
Outcome measures
| Measure |
Belimumab 10 mg/kg IV
n=296 Participants
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 1, Week 8, n=285
|
-6.09 Percent change
Interval -46.4 to 116.5
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 1, Week 16, n=289
|
-7.69 Percent change
Interval -47.7 to 82.4
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 1, Week 24, n=290
|
-8.78 Percent change
Interval -69.6 to 165.0
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 1, Week 32, n=288
|
-8.84 Percent change
Interval -47.6 to 41.6
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 1, Week 40, n=285
|
-10.32 Percent change
Interval -44.4 to 32.2
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 1, Week 48, n=286
|
-9.34 Percent change
Interval -46.3 to 33.8
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 2, Week 8, n=283
|
-11.40 Percent change
Interval -46.0 to 43.3
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 2, Week 16, n=281
|
-10.76 Percent change
Interval -50.8 to 47.3
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 2, Week 24, n=285
|
-11.19 Percent change
Interval -51.7 to 66.3
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 2, Week 32, n=281
|
-11.40 Percent change
Interval -52.9 to 54.0
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 2, Week 40, n=266
|
-10.29 Percent change
Interval -49.9 to 93.0
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 2, Week 48, n=267
|
-10.54 Percent change
Interval -58.0 to 103.0
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 3, Week 8, n=263
|
-10.28 Percent change
Interval -50.4 to 62.9
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 3, Week 16, n=258
|
-9.92 Percent change
Interval -53.3 to 52.9
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 3, Week 24, n=242
|
-9.77 Percent change
Interval -56.6 to 60.3
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 3, Week 32, n=248
|
-8.93 Percent change
Interval -52.0 to 45.7
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 3, Week 40, n=244
|
-8.04 Percent change
Interval -54.9 to 46.3
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 3, Week 48, n=242
|
-10.40 Percent change
Interval -52.3 to 45.0
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 4, Week 8, n=238
|
-10.70 Percent change
Interval -55.3 to 46.2
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 4, Week 16, n=238
|
-10.77 Percent change
Interval -54.9 to 145.1
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 4, Week 24, n=226
|
-11.73 Percent change
Interval -72.6 to 37.5
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 4, Week 32, n=231
|
-10.99 Percent change
Interval -53.5 to 48.2
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 4, Week 40, n=218
|
-10.47 Percent change
Interval -54.9 to 47.7
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 4, Week 48, n=220
|
-11.69 Percent change
Interval -59.2 to 57.3
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 5, Week 8, n=216
|
-13.20 Percent change
Interval -61.8 to 45.6
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 5, Week 16, n=213
|
-14.62 Percent change
Interval -64.2 to 45.5
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 5, Week 24, n=210
|
-14.61 Percent change
Interval -59.9 to 89.6
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 5, Week 32, n=209
|
-13.24 Percent change
Interval -54.5 to 29.7
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 5, Week 40, n=197
|
-15.97 Percent change
Interval -54.8 to 42.4
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 5, Week 48, n=207
|
-15.47 Percent change
Interval -57.0 to 38.6
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 6, Week 8, n=205
|
-17.13 Percent change
Interval -73.7 to 40.9
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 6, Week 16, n=197
|
-18.16 Percent change
Interval -75.0 to 32.6
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 6, Week 24, n=190
|
-18.67 Percent change
Interval -64.5 to 36.4
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 6, Week 32, n=195
|
-19.83 Percent change
Interval -65.0 to 42.4
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 6, Week 40, n=184
|
-19.84 Percent change
Interval -61.9 to 26.6
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 6, Week 48, n=186
|
-22.36 Percent change
Interval -79.4 to 39.2
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 7, Week 8, n=181
|
-21.26 Percent change
Interval -64.4 to 29.4
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 7, Week 16, n=180
|
-21.22 Percent change
Interval -68.7 to 45.0
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 7, Week 24, n=175
|
-21.39 Percent change
Interval -71.5 to 39.9
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 7, Week 32, n=180
|
-22.03 Percent change
Interval -71.8 to 45.5
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 7, Week 40, n=175
|
-22.31 Percent change
Interval -71.7 to 24.5
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 7, Week 48, n=175
|
-22.20 Percent change
Interval -69.0 to 25.4
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 8, Week 8, n=171
|
-24.44 Percent change
Interval -74.3 to 46.9
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 8, Week 16, n=170
|
-25.51 Percent change
Interval -76.3 to 26.6
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 8, Week 24, n=167
|
-24.91 Percent change
Interval -76.6 to 32.4
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 8, Week 32, n=168
|
-24.48 Percent change
Interval -76.3 to 59.9
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 8, Week 40, n=161
|
-25.50 Percent change
Interval -76.8 to 87.8
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 8, Week 48, n=159
|
-24.58 Percent change
Interval -76.0 to 78.9
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 9, Week 8, n=165
|
-25.41 Percent change
Interval -77.8 to 100.4
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 9, Week 16, n=161
|
-25.44 Percent change
Interval -80.6 to 23.7
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 9, Week 24, n=161
|
-27.23 Percent change
Interval -78.8 to 155.8
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 9, Week 32, n=162
|
-26.92 Percent change
Interval -79.6 to 168.3
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 9, Week 40, n=157
|
-27.63 Percent change
Interval -78.9 to 164.8
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 9, Week 48, n=149
|
-26.48 Percent change
Interval -79.4 to 184.4
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 10, Week 8, n=151
|
-28.65 Percent change
Interval -78.7 to 125.4
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 10, Week 16, n=144
|
-28.45 Percent change
Interval -74.0 to 130.8
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 10, Week 24, n=144
|
-28.78 Percent change
Interval -73.8 to 211.3
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 10, Week 32, n=140
|
-27.98 Percent change
Interval -74.4 to 161.2
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 10, Week 40, n=137
|
-28.57 Percent change
Interval -97.6 to 98.6
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 10, Week 48, n=136
|
-28.86 Percent change
Interval -72.9 to 164.8
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 11, Week 8, n=138
|
-28.91 Percent change
Interval -71.9 to 61.7
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 11, Week 16, n=128
|
-29.34 Percent change
Interval -69.8 to 48.1
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 11, Week 24, n=130
|
-29.64 Percent change
Interval -68.0 to 180.9
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 11, Week 32, n=127
|
-29.50 Percent change
Interval -67.6 to 72.5
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 11, Week 40, n=123
|
-27.58 Percent change
Interval -68.9 to 202.3
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 11, Week 48, n=107
|
-27.13 Percent change
Interval -67.0 to 200.5
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 12, Week 8, n=110
|
-29.27 Percent change
Interval -68.5 to 220.2
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 12, Week 16, n=98
|
-30.30 Percent change
Interval -70.5 to 14.4
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 12, Week 24, n=86
|
-30.25 Percent change
Interval -66.0 to 28.5
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 12, Week 32, n=87
|
-30.72 Percent change
Interval -72.6 to 12.2
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 12, Week 40, n=83
|
-32.96 Percent change
Interval -96.4 to 9.9
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 12, Week 48, n=72
|
-31.72 Percent change
Interval -65.5 to 13.2
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 13, Week 8, n=52
|
-32.23 Percent change
Interval -65.7 to 5.3
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 13, Week 16, n=42
|
-31.91 Percent change
Interval -67.0 to 3.5
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 13, Week 24, n=20
|
-28.18 Percent change
Interval -54.9 to 5.3
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 13, Week 32, n=7
|
-33.06 Percent change
Interval -58.2 to -7.8
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Year 13, Week 40, n=1
|
-12.9 Percent change
Interval -12.9 to -12.9
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Exit, n=245
|
-23.37 Percent change
Interval -72.0 to 200.5
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
8-Week follow-up, n=220
|
-24.79 Percent change
Interval -75.1 to 270.3
|
|
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
24-Week follow-up, n=198
|
-22.09 Percent change
Interval -77.9 to 245.3
|
Adverse Events
Belimumab 10 mg/kg IV
Serious events: 182 serious events
Other events: 293 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Belimumab 10 mg/kg IV
n=296 participants at risk
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
General disorders
Chest discomfort
|
1.0%
3/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.0%
3/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
3/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Gastroenteritis
|
1.0%
3/296 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.0%
3/296 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Headache
|
1.0%
3/296 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.0%
3/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Ileus
|
1.0%
3/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Injury
|
1.0%
3/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
1.0%
3/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
1.0%
3/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
1.0%
3/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Pneumonia bacterial
|
1.0%
3/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Renal and urinary disorders
Proteinuria
|
1.0%
3/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Pyelonephritis
|
1.0%
3/296 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.0%
3/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Sepsis
|
1.0%
3/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Septic shock
|
1.0%
3/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.0%
3/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
1.0%
3/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.0%
3/296 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.0%
3/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Angina pectoris
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Vascular disorders
Arteriosclerosis
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.68%
2/296 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Asthenia
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Bacterial sepsis
|
0.68%
2/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Pneumonia
|
6.8%
20/296 • Number of events 22 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.7%
14/296 • Number of events 19 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Non-cardiac chest pain
|
4.1%
12/296 • Number of events 17 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Pyrexia
|
3.7%
11/296 • Number of events 14 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Cellulitis
|
3.4%
10/296 • Number of events 13 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.0%
9/296 • Number of events 12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.7%
8/296 • Number of events 8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Gastroenteritis viral
|
2.7%
8/296 • Number of events 11 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.4%
7/296 • Number of events 13 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
2.4%
7/296 • Number of events 7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
7/296 • Number of events 11 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
6/296 • Number of events 10 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Bronchitis
|
2.0%
6/296 • Number of events 9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
6/296 • Number of events 8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
6/296 • Number of events 8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Vascular disorders
Hypotension
|
2.0%
6/296 • Number of events 8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
2.0%
6/296 • Number of events 9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Appendicitis
|
1.7%
5/296 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
5/296 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Hiatus hernia
|
1.7%
5/296 • Number of events 6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Vascular disorders
Hypertension
|
1.7%
5/296 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
1.7%
5/296 • Number of events 6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.7%
5/296 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Renal and urinary disorders
Lupus nephritis
|
1.7%
5/296 • Number of events 6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Syncope
|
1.7%
5/296 • Number of events 6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
4/296 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
4/296 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Coronary artery disease
|
1.4%
4/296 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Vascular disorders
Deep vein thrombosis
|
1.4%
4/296 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
4/296 • Number of events 6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Migraine
|
1.4%
4/296 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
4/296 • Number of events 9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
4/296 • Number of events 8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Pericarditis lupus
|
1.4%
4/296 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.4%
4/296 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
4/296 • Number of events 7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
1.4%
4/296 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.0%
3/296 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.0%
3/296 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Reproductive system and breast disorders
Cystocele
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Psychiatric disorders
Depression
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Immune system disorders
Drug hypersensitivity
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Epilepsy
|
0.68%
2/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Gastritis
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Haemoglobin decreased
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Hypoaesthesia
|
0.68%
2/296 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.68%
2/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Myocardial infarction
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.68%
2/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.68%
2/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Paraesthesia
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Presyncope
|
0.68%
2/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.68%
2/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Renal and urinary disorders
Renal failure
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.68%
2/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Seizure
|
0.68%
2/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.68%
2/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.68%
2/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Viral infection
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.68%
2/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Abscess limb
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.34%
1/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Anal abscess
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Appendicitis noninfective
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Appendicitis perforated
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Arthritis bacterial
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Ascites
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Benign intracranial hypertension
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Blood creatinine increased
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Blood potassium decreased
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Vascular disorders
Blood pressure fluctuation
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Bradycardia
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Bronchitis bacterial
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Cardiac arrest
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.34%
1/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Catheter site cellulitis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Central nervous system lupus
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Cerebral haematoma
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Cervical myelopathy
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Chest pain
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Hepatobiliary disorders
Cholangitis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.34%
1/296 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Clostridium difficile infection
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage III
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Reproductive system and breast disorders
Colpocele
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Psychiatric disorders
Completed suicide
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.34%
1/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Psychiatric disorders
Confusional state
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Cystitis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Diverticulitis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Dizziness
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Drug withdrawal syndrome
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Vascular disorders
Dry gangrene
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Dysarthria
|
0.34%
1/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Dyskinesia oesophageal
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Encephalopathy
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage I
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Endometritis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Escherichia sepsis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Extradural abscess
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Extrasystoles
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Fatigue
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Gait disturbance
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.34%
1/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Haematocrit decreased
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Horner's syndrome
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Vascular disorders
Hypertensive crisis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Eye disorders
Idiopathic orbital inflammation
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Impaired healing
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Implant site infection
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Infectious colitis
|
0.34%
1/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Influenza
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
International normalised ratio increased
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.34%
1/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Intervertebral discitis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Lung infection pseudomonal
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Lupus enteritis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Psychiatric disorders
Major depression
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Medical device complication
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Megacolon
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.34%
1/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Mouth swelling
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Myocarditis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Vascular disorders
Necrosis ischaemic
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Neuralgia
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Metabolism and nutrition disorders
Obesity
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Odynophagia
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Oedema peripheral
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Oesophageal mass
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Osteomyelitis
|
0.34%
1/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.34%
1/296 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.34%
1/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Pericarditis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Pneumonia fungal
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Reproductive system and breast disorders
Polycystic ovaries
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Pyelonephritis acute
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.34%
1/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Reproductive system and breast disorders
Rectocele
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.34%
1/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.34%
1/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.34%
1/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
SLE arthritis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.34%
1/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Serositis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Skin bacterial infection
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Spinal epidural haemorrhage
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Staphylococcal infection
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Social circumstances
Stress at work
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Psychiatric disorders
Suicide attempt
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Surgical failure
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Tachycardia
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Tooth abscess
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.34%
1/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Reproductive system and breast disorders
Uterine pain
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Vascular disorders
Vasculitis
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.34%
1/296 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Volvulus of small bowel
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Reproductive system and breast disorders
Vulvar dysplasia
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
West Nile viral infection
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
White blood cell count decreased
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
White blood cell count increased
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.34%
1/296 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
Other adverse events
| Measure |
Belimumab 10 mg/kg IV
n=296 participants at risk
Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
73.3%
217/296 • Number of events 697 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.2%
196/296 • Number of events 703 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Headache
|
52.4%
155/296 • Number of events 358 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Sinusitis
|
47.6%
141/296 • Number of events 409 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Nausea
|
47.3%
140/296 • Number of events 331 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Fatigue
|
46.3%
137/296 • Number of events 277 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Urinary tract infection
|
46.3%
137/296 • Number of events 384 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
41.9%
124/296 • Number of events 225 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
41.9%
124/296 • Number of events 246 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
38.5%
114/296 • Number of events 231 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Bronchitis
|
37.2%
110/296 • Number of events 251 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Psychiatric disorders
Insomnia
|
37.2%
110/296 • Number of events 143 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
36.1%
107/296 • Number of events 204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
34.1%
101/296 • Number of events 211 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.1%
98/296 • Number of events 149 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Psychiatric disorders
Depression
|
31.8%
94/296 • Number of events 119 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
31.1%
92/296 • Number of events 153 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Vomiting
|
29.1%
86/296 • Number of events 146 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Oedema peripheral
|
28.0%
83/296 • Number of events 166 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.7%
76/296 • Number of events 121 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Vascular disorders
Hypertension
|
24.7%
73/296 • Number of events 105 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Pyrexia
|
24.7%
73/296 • Number of events 147 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Immune system disorders
Seasonal allergy
|
24.7%
73/296 • Number of events 89 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Influenza
|
24.0%
71/296 • Number of events 96 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Nasopharyngitis
|
24.0%
71/296 • Number of events 135 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
23.6%
70/296 • Number of events 117 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.0%
68/296 • Number of events 102 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
22.6%
67/296 • Number of events 113 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
22.6%
67/296 • Number of events 95 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Contusion
|
22.3%
66/296 • Number of events 110 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Dizziness
|
21.6%
64/296 • Number of events 101 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
21.3%
63/296 • Number of events 115 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Migraine
|
20.9%
62/296 • Number of events 123 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Psychiatric disorders
Anxiety
|
20.6%
61/296 • Number of events 74 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Mouth ulceration
|
20.3%
60/296 • Number of events 131 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Non-cardiac chest pain
|
20.3%
60/296 • Number of events 88 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Gastroenteritis viral
|
19.9%
59/296 • Number of events 82 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Fall
|
19.6%
58/296 • Number of events 116 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
19.6%
58/296 • Number of events 90 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Gastroenteritis
|
18.2%
54/296 • Number of events 86 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.9%
53/296 • Number of events 80 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
17.9%
53/296 • Number of events 84 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Constipation
|
17.2%
51/296 • Number of events 59 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
17.2%
51/296 • Number of events 70 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Peripheral swelling
|
16.6%
49/296 • Number of events 64 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
16.2%
48/296 • Number of events 99 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Chest X-ray
|
15.9%
47/296 • Number of events 74 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.9%
47/296 • Number of events 61 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
15.9%
47/296 • Number of events 84 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
15.5%
46/296 • Number of events 67 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Herpes zoster
|
15.2%
45/296 • Number of events 64 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Pain
|
15.2%
45/296 • Number of events 57 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.9%
44/296 • Number of events 62 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Tooth abscess
|
14.5%
43/296 • Number of events 52 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Blood and lymphatic system disorders
Anaemia
|
14.2%
42/296 • Number of events 50 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Oral candidiasis
|
14.2%
42/296 • Number of events 68 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Weight increased
|
14.2%
42/296 • Number of events 61 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.5%
40/296 • Number of events 66 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.2%
39/296 • Number of events 45 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Colonoscopy
|
12.8%
38/296 • Number of events 41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Hypoaesthesia
|
12.8%
38/296 • Number of events 46 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
37/296 • Number of events 57 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
12.5%
37/296 • Number of events 56 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.2%
36/296 • Number of events 73 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
12.2%
36/296 • Number of events 52 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
11.8%
35/296 • Number of events 48 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
11.8%
35/296 • Number of events 46 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Oral herpes
|
11.8%
35/296 • Number of events 68 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Paraesthesia
|
11.8%
35/296 • Number of events 46 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.8%
35/296 • Number of events 49 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Weight decreased
|
11.8%
35/296 • Number of events 39 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
11.5%
34/296 • Number of events 48 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
11.1%
33/296 • Number of events 80 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Eye disorders
Dry eye
|
11.1%
33/296 • Number of events 38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.8%
32/296 • Number of events 46 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
10.8%
32/296 • Number of events 42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
10.8%
32/296 • Number of events 41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Otitis media
|
10.8%
32/296 • Number of events 44 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.8%
32/296 • Number of events 56 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Dental caries
|
10.5%
31/296 • Number of events 42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Pharyngitis
|
10.5%
31/296 • Number of events 39 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Pneumonia
|
10.5%
31/296 • Number of events 41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Toothache
|
10.5%
31/296 • Number of events 36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Ear and labyrinth disorders
Vertigo
|
10.5%
31/296 • Number of events 36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Laceration
|
10.1%
30/296 • Number of events 38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Nuclear magnetic resonance imaging
|
9.8%
29/296 • Number of events 39 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Renal and urinary disorders
Proteinuria
|
9.8%
29/296 • Number of events 42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
9.5%
28/296 • Number of events 36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Cellulitis
|
9.5%
28/296 • Number of events 37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
9.5%
28/296 • Number of events 41 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
9.5%
28/296 • Number of events 58 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Eye disorders
Cataract
|
9.1%
27/296 • Number of events 34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
9.1%
27/296 • Number of events 40 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.1%
27/296 • Number of events 50 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
8.8%
26/296 • Number of events 27 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
8.8%
26/296 • Number of events 34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
8.8%
26/296 • Number of events 33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Tooth infection
|
8.8%
26/296 • Number of events 37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
X-ray limb
|
8.8%
26/296 • Number of events 49 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Conjunctivitis
|
8.4%
25/296 • Number of events 39 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
8.4%
25/296 • Number of events 34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Electrocardiogram
|
8.4%
25/296 • Number of events 32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Endocrine disorders
Hypothyroidism
|
8.4%
25/296 • Number of events 27 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.1%
24/296 • Number of events 27 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
8.1%
24/296 • Number of events 25 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
8.1%
24/296 • Number of events 25 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Cardiac disorders
Palpitations
|
8.1%
24/296 • Number of events 27 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
8.1%
24/296 • Number of events 37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.1%
24/296 • Number of events 42 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
8.1%
24/296 • Number of events 25 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Butterfly rash
|
7.8%
23/296 • Number of events 31 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
SLE arthritis
|
7.8%
23/296 • Number of events 38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
7.8%
23/296 • Number of events 24 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Bone densitometry
|
7.4%
22/296 • Number of events 23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Dry mouth
|
7.4%
22/296 • Number of events 24 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
7.4%
22/296 • Number of events 22 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
7.4%
22/296 • Number of events 37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Sciatica
|
7.4%
22/296 • Number of events 25 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
7.4%
22/296 • Number of events 31 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
7.4%
22/296 • Number of events 31 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.1%
21/296 • Number of events 21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
21/296 • Number of events 27 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Gastritis
|
7.1%
21/296 • Number of events 25 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
7.1%
21/296 • Number of events 28 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
7.1%
21/296 • Number of events 27 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Vascular disorders
Raynaud's phenomenon
|
7.1%
21/296 • Number of events 33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
7.1%
21/296 • Number of events 22 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Chills
|
6.8%
20/296 • Number of events 34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Computerised tomogram
|
6.8%
20/296 • Number of events 22 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
6.8%
20/296 • Number of events 47 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.8%
20/296 • Number of events 28 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Ear and labyrinth disorders
Ear pain
|
6.8%
20/296 • Number of events 27 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Fungal skin infection
|
6.8%
20/296 • Number of events 30 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.8%
20/296 • Number of events 24 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
General disorders
Infusion site extravasation
|
6.8%
20/296 • Number of events 25 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Mammogram
|
6.8%
20/296 • Number of events 32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Pharyngitis streptococcal
|
6.8%
20/296 • Number of events 25 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
6.8%
20/296 • Number of events 23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.4%
19/296 • Number of events 20 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.4%
19/296 • Number of events 25 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.4%
19/296 • Number of events 25 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.4%
19/296 • Number of events 24 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.4%
19/296 • Number of events 24 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
6.4%
19/296 • Number of events 29 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.4%
19/296 • Number of events 24 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Creatinine renal clearance decreased
|
6.1%
18/296 • Number of events 24 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Onychomycosis
|
6.1%
18/296 • Number of events 22 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.1%
18/296 • Number of events 23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Restless legs syndrome
|
6.1%
18/296 • Number of events 19 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Nervous system disorders
Sinus headache
|
6.1%
18/296 • Number of events 29 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
6.1%
18/296 • Number of events 22 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
X-ray of pelvis and hip
|
6.1%
18/296 • Number of events 24 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Computerised tomogram abdomen
|
5.7%
17/296 • Number of events 17 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
5.7%
17/296 • Number of events 19 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Dysphagia
|
5.7%
17/296 • Number of events 19 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
5.7%
17/296 • Number of events 20 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.7%
17/296 • Number of events 24 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Nuclear magnetic resonance imaging spinal
|
5.7%
17/296 • Number of events 21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Spinal X-ray
|
5.7%
17/296 • Number of events 24 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Investigations
Computerised tomogram head
|
5.4%
16/296 • Number of events 22 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
5.4%
16/296 • Number of events 22 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Renal and urinary disorders
Dysuria
|
5.4%
16/296 • Number of events 18 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.4%
16/296 • Number of events 21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Renal and urinary disorders
Haematuria
|
5.4%
16/296 • Number of events 19 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.4%
16/296 • Number of events 19 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
5.4%
16/296 • Number of events 19 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Skin infection
|
5.4%
16/296 • Number of events 18 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
5.4%
16/296 • Number of events 29 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Urinary tract infection bacterial
|
5.4%
16/296 • Number of events 28 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Infections and infestations
Viral infection
|
5.4%
16/296 • Number of events 17 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.1%
15/296 • Number of events 17 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Gastrointestinal disorders
Hiatus hernia
|
5.1%
15/296 • Number of events 17 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.1%
15/296 • Number of events 26 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
5.1%
15/296 • Number of events 16 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
5.1%
15/296 • Number of events 15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Renal and urinary disorders
Pollakiuria
|
5.1%
15/296 • Number of events 16 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
5.1%
15/296 • Number of events 18 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
5.1%
15/296 • Number of events 24 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
5.1%
15/296 • Number of events 16 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
|
Injury, poisoning and procedural complications
Wound
|
5.1%
15/296 • Number of events 18 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
|
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