Trial Outcomes & Findings for A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057 (NCT NCT00712933)
NCT ID: NCT00712933
Last Updated: 2019-12-05
Results Overview
An adverse event 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: increase in frequency or severity) of preexisting conditions. Participants with incidences of any event at any time post-baseline are presented by yearly interval. Only treatment-emergent AEs are summarized.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
738 participants
Primary outcome timeframe
Up to 9 years
Results posted on
2019-12-05
Participant Flow
This was a multi-center, continuation trial of belimumab and was conducted at 115 centers in 28 countries. Participants with Systemic Lupus Erythematosus (SLE), who had completed the Phase 3 HGS1006-C1056 or HGS1006-C1057 trial or participants who had previously received subcutaneous belimumab in Protocol HGS1006-C1070 were included in this trial.
738 participants were enrolled in the study and 735 received at least one dose of belimumab.Out of 735 participants, 368 completed the study and 370 withdrew from the study.
Participant milestones
| Measure |
Belimumab 10mg/kg IV
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
|---|---|
|
Overall Study
STARTED
|
735
|
|
Overall Study
COMPLETED
|
368
|
|
Overall Study
NOT COMPLETED
|
367
|
Reasons for withdrawal
| Measure |
Belimumab 10mg/kg IV
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
|---|---|
|
Overall Study
Adverse Event
|
69
|
|
Overall Study
Lack of Efficacy
|
6
|
|
Overall Study
Lost to Follow-up
|
22
|
|
Overall Study
Non-compliance with study drug
|
13
|
|
Overall Study
Other Pregnancy
|
37
|
|
Overall Study
Sponsor decision
|
14
|
|
Overall Study
Withdrew consent
|
4
|
|
Overall Study
Hip replacement surgery
|
1
|
|
Overall Study
Involved in Clinical research
|
3
|
|
Overall Study
Participant hospitalized
|
1
|
|
Overall Study
Participant travelled overseas
|
2
|
|
Overall Study
Death of patient
|
1
|
|
Overall Study
Other Physician decision
|
1
|
|
Overall Study
Not committed to contraception
|
1
|
|
Overall Study
Participant received medication
|
1
|
|
Overall Study
Physician Decision
|
36
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Withdrawal by Subject
|
151
|
Baseline Characteristics
A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057
Baseline characteristics by cohort
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
|---|---|
|
Age, Continuous
|
37.2 Years
STANDARD_DEVIATION 11.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
695 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American/African Heritage
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
225 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian Heritage
|
118 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South Asian Heritage
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Southeast Asian Heritage
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle East/North African Heritage
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian/European Heritage
|
256 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 9 yearsPopulation: MITT Population
An adverse event 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: increase in frequency or severity) of preexisting conditions. Participants with incidences of any event at any time post-baseline are presented by yearly interval. Only treatment-emergent AEs are summarized.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AE)
Year 8 plus,n = 6
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
Any-time post Baseline,n=735
|
706 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
Year 0-1,n=735
|
617 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
Year 1-2 ,n =701
|
502 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
Year 2-3, n= 620
|
441 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
Year 3-4,n= 514
|
344 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
Year 4-5,n= 442
|
261 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
Year 5-6, n =345
|
181 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
Year 6-7, n= 219
|
92 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AE)
Year 7-8, n = 65
|
26 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 9 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 treatment-emergent AEs are summarized. The event rate of an AE was calculated as the number of events per 100 participant years. Participant years were calculated as sum across all participants (\[last visit of interval day - first visit of interval day + 1\] divided by365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=3352 Subject years
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
AE Rates by System Organ Class (SOC) During the Study
Infections and infestations
|
101.8 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Gastrointestinal disorders
|
32.8 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Musculoskeletal and connective tissuedisorder
|
32.8 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Nervous system disorders
|
22.6 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Skin and subcutaneous and tissue disorders
|
22.5 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Respiratory,thoracic and mediastinal disorder
|
14.9 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Vascular disorders
|
13.3 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
General disorders and administration sitecondition
|
11.8 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Injury, poisoning andprocedural complications
|
11.5 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Blood and lymphatic system disorders
|
7.5 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Eye disorders
|
6.6 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Reproductive system and breast disorders
|
6.4 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Investigations
|
5.8 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Psychiatric disorders
|
5.6 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Renal and urinary and disorder
|
5.3 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Metabolism and nutrition disorder
|
3.6 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Cardiac disorders
|
3.0 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Ear and labyrinth disorder
|
2.4 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Neoplasms benign,malignant andunspecified
|
2.2 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Hepatobiliary disorders
|
1.8 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Immune system disorder
|
1.2 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Endocrine disorders
|
1.0 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Social circumstances
|
0.7 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Congenital, familial and genetic disorders
|
0.1 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Pregnancy, puerperium and perinatal conditions
|
0.1 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
AE Rates by System Organ Class (SOC) During the Study
Product Issues
|
0.1 Adverse events per 100 participant years
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 9 yearsPopulation: MITT Population
An adverse event resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important is categorized as SAE. Only treatment-emergent AEs are summarized.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAE)
Any post-Baseline,n=735
|
231 Participants
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAE)
Year 0-1,n=735
|
78 Participants
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAE)
Year 1-2,n = 701
|
58 Participants
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAE)
Year 2-3,n = 620
|
66 Participants
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAE)
Year 3-4,n= 514
|
44 Participants
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAE)
Year 4-5 ,n= 442
|
27 Participants
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAE)
Year 5-6,n=345
|
16 Participants
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAE)
Year 6-7,n= 219
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAE)
Year 7-8,n= 65
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAE)
Year 8 plus,n= 6
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 9 yearsPopulation: MITT Population
SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The event rate of an SAE was calculated as the number of events per 100 participant years. Participants years were calculated as = sum across all participants (\[last visit of interval day - first visit of interval day + 1\] divided by 365). Participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=3352 Subject years
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
SAE Rates by SOC During the Study
Infections and infestations
|
5.1 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Blood and lymphatic system disorders
|
1.0 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Musculoskeletal and connective tissue disorder
|
1.0 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Gastrointestinal disorders
|
1.0 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Renal and urinary disorders
|
0.8 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Vascular disorders
|
0.8 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Injury, poisoning andprocedural complications
|
0.8 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
General disorders and administration sitecondition
|
0.6 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Nervous system disorders
|
0.6 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Respiratory, thoracic and mediastinal disorder
|
0.5 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Cardiac disorders
|
0.5 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Skin and subcutaneous tissue disorders
|
0.5 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Neoplasms benign, malignant and unspecified
|
0.4 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Reproductive system and breast disorder
|
0.4 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Psychiatric disorders
|
0.4 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Hepatobiliary disorders
|
0.3 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Metabolism and nutrition disorders
|
0.1 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Pregnancy, puerperium and perinatal condition
|
0.1 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Endocrine disorders
|
0.1 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Immune system disorders
|
0.1 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Ear and labyrinth disorders
|
0.1 Adverse events per 100 participant years
|
—
|
—
|
—
|
|
SAE Rates by SOC During the Study
Eye disorders
|
0.1 Adverse events per 100 participant years
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to 9 yearsPopulation: MITT Population
Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year1,Week4,APTT,n=208
|
0.7 Seconds
Standard Deviation 5.27
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year1,Week12,APTT,n=208
|
2.1 Seconds
Standard Deviation 12.31
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year1,Week24,APTT,n=686
|
0.1 Seconds
Standard Deviation 9.10
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year1,Week36,APTT,n=193
|
2.5 Seconds
Standard Deviation 5.75
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year1,Week48,APTT,n=666
|
0.8 Seconds
Standard Deviation 9.48
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year2,Week24,APTT,n=625
|
2.7 Seconds
Standard Deviation 9.74
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year2,Week48,APTT,n=572
|
2.7 Seconds
Standard Deviation 9.66
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year3,Week24,APTT,n=521
|
3.4 Seconds
Standard Deviation 10.01
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year3,Week48,APTT,n=470
|
3.9 Seconds
Standard Deviation 11.41
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year4,Week24,APTT,n=422
|
3.5 Seconds
Standard Deviation 10.70
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year4,Week48,APTT,n=412
|
4.2 Seconds
Standard Deviation 6.63
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year5,Week24,APTT,n=383
|
4.1 Seconds
Standard Deviation 10.71
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year5,Week48,APTT,n=349
|
3.5 Seconds
Standard Deviation 6.35
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year6,Week24,APTT,n=292
|
3.8 Seconds
Standard Deviation 6.58
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year6,Week48,APTT,n=277
|
4.3 Seconds
Standard Deviation 7.91
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year7,Week24,APTT,n=177
|
6.4 Seconds
Standard Deviation 14.52
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year7,Week48,APTT,n=131
|
4.1 Seconds
Standard Deviation 6.23
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year8,Week24,APTT,n=52
|
5.6 Seconds
Standard Deviation 7.54
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year8,Week48,APTT,n=13
|
4.2 Seconds
Standard Deviation 3.98
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year9,Week24,APTT,n=6
|
5.0 Seconds
Standard Deviation 6.39
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year9,Week48,APTT,n=1
|
9.0 Seconds
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Exit, APTT,n=586
|
3.2 Seconds
Standard Deviation 10.71
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
8 Week,Follow up,n=524
|
3.4 Seconds
Standard Deviation 8.14
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year1,Week4,PT,n=205
|
-0.22 Seconds
Standard Deviation 5.139
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year1,Week12,PT,n=206
|
1.71 Seconds
Standard Deviation 19.533
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year1,Week24,PT,n=686
|
-0.43 Seconds
Standard Deviation 8.267
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year1,Week36,PT,n=193
|
0.13 Seconds
Standard Deviation 3.357
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year1,Week48,PT,n=666
|
-0.45 Seconds
Standard Deviation 8.174
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year2,Week24,PT,n=626
|
0.15 Seconds
Standard Deviation 11.528
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year2,Week48,PT,n=572
|
-0.26 Seconds
Standard Deviation 8.925
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year3,Week24,PT,n=521
|
0.12 Seconds
Standard Deviation 9.609
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year3,Week48,PT,n=469
|
0.63 Seconds
Standard Deviation 14.334
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year4,Week24,PT,n=422
|
0.06 Seconds
Standard Deviation 10.458
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year4,Week48,PT,n=412
|
0.40 Seconds
Standard Deviation 4.228
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year5,Week24,PT,n=384
|
-0.14 Seconds
Standard Deviation 10.810
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year5,Week48,PT,n=349
|
0.61 Seconds
Standard Deviation 11.276
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year6,Week24,PT,n=292
|
0.64 Seconds
Standard Deviation 8.023
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year6,Week48,PT,n=278
|
0.85 Seconds
Standard Deviation 12.414
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year7,Week24,PT,n=177
|
1.76 Seconds
Standard Deviation 14.272
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year7,Week48,PT,n=131
|
0.36 Seconds
Standard Deviation 2.290
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year8,Week24,PT,n=52
|
1.21 Seconds
Standard Deviation 6.716
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year8,Week48,PT,n=13
|
0.52 Seconds
Standard Deviation 0.600
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year9,Week24,PT,n=6
|
0.50 Seconds
Standard Deviation 0.657
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Year9,Week48,PT,n=1
|
1.00 Seconds
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Exit,PT, n=587
|
0.25 Seconds
Standard Deviation 9.973
|
—
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
8 Week, Follow up,n=524
|
0.50 Seconds
Standard Deviation 4.965
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to 9 yearsPopulation: MITT Population
Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Plt, Lymp, Leu, Eos, Baso, Mono, Neu, NeuBF, and NueS are summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year1,Week4,n=693
|
0.002 Billion cells per liter
Standard Deviation 0.0172
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year1,Week12,n=694
|
0.002 Billion cells per liter
Standard Deviation 0.0187
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year1,Week24,n=696
|
0.002 Billion cells per liter
Standard Deviation 0.0176
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year1,Week36,n=682
|
0.002 Billion cells per liter
Standard Deviation 0.0179
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year1,Week48,n=684
|
0.003 Billion cells per liter
Standard Deviation 0.0183
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year2,Week24,n=629
|
0.004 Billion cells per liter
Standard Deviation 0.0190
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year2,Week48,n=589
|
0.004 Billion cells per liter
Standard Deviation 0.0200
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year3,Week24,n=533
|
0.005 Billion cells per liter
Standard Deviation 0.0165
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year3,Week48,n=476
|
0.008 Billion cells per liter
Standard Deviation 0.0194
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year4,Week24,n=446
|
0.007 Billion cells per liter
Standard Deviation 0.0192
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year4,Week48,n=423
|
0.008 Billion cells per liter
Standard Deviation 0.0202
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year5,Week24,n=389
|
0.007 Billion cells per liter
Standard Deviation 0.0191
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year5,Week48,n=360
|
0.005 Billion cells per liter
Standard Deviation 0.0191
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year6,Week24,n=306
|
0.006 Billion cells per liter
Standard Deviation 0.0184
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year6,Week48,n=282
|
0.007 Billion cells per liter
Standard Deviation 0.0198
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year7,Week24,n=181
|
0.007 Billion cells per liter
Standard Deviation 0.0211
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year7,Week48,n=130
|
0.012 Billion cells per liter
Standard Deviation 0.0259
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year8,Week24,n=52
|
0.014 Billion cells per liter
Standard Deviation 0.0187
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year8,Week48,n=13
|
0.001 Billion cells per liter
Standard Deviation 0.0166
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year9,Week24,n=6
|
0.003 Billion cells per liter
Standard Deviation 0.0082
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Year9,Week48,n=1
|
0.010 Billion cells per liter
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,Exit,n=614
|
0.005 Billion cells per liter
Standard Deviation 0.0204
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Baso,8 Week,Follow up,n=532
|
0.009 Billion cells per liter
Standard Deviation 0.0253
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year1,Week4,n=693
|
0.007 Billion cells per liter
Standard Deviation 0.1597
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year1,Week12,n=694
|
0.003 Billion cells per liter
Standard Deviation 0.1595
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year1,Week24,n=696
|
0.000 Billion cells per liter
Standard Deviation 0.1614
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year1,Week36,n=682
|
0.020 Billion cells per liter
Standard Deviation 0.1866
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year1,Week48,n=684
|
0.001 Billion cells per liter
Standard Deviation 0.1763
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year2,Week24,n=629
|
0.004 Billion cells per liter
Standard Deviation 0.1605
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year2,Week48,n=589
|
-0.004 Billion cells per liter
Standard Deviation 0.1858
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year3,Week24,n=533
|
-0.011 Billion cells per liter
Standard Deviation 0.2074
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year3,Week48,n=476
|
-0.026 Billion cells per liter
Standard Deviation 0.2053
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year4,Week24,n=446
|
-0.041 Billion cells per liter
Standard Deviation 0.1792
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year4,Week48,n=423
|
-0.047 Billion cells per liter
Standard Deviation 0.1676
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year5,Week24,n=389
|
-0.035 Billion cells per liter
Standard Deviation 0.1949
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year5,Week48,n=360
|
-0.045 Billion cells per liter
Standard Deviation 0.1807
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year6,Week24,n=306
|
-0.046 Billion cells per liter
Standard Deviation 0.1801
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year6,Week48,n=282
|
-0.037 Billion cells per liter
Standard Deviation 0.1976
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year7,Week24,n=181
|
-0.046 Billion cells per liter
Standard Deviation 0.1710
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year7,Week48,n=130
|
-0.020 Billion cells per liter
Standard Deviation 0.2276
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year8,Week24,n=52
|
-0.017 Billion cells per liter
Standard Deviation 0.1753
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year8,Week48,n=13
|
-0.041 Billion cells per liter
Standard Deviation 0.1130
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year9,Week24,n=6
|
-0.088 Billion cells per liter
Standard Deviation 0.1078
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos,Year9,Week48,n=1
|
-0.040 Billion cells per liter
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eos, Exit, n=614
|
-0.026 Billion cells per liter
Standard Deviation 0.1754
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Eso, 8 Week Follow up, n=532
|
-0.030 Billion cells per liter
Standard Deviation 0.1920
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year1,Week4,n=696
|
0.16 Billion cells per liter
Standard Deviation 1.928
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year1,Week12,n=697
|
0.19 Billion cells per liter
Standard Deviation 2.106
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year1,Week24,n=697
|
0.04 Billion cells per liter
Standard Deviation 2.142
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year1,Week36,n=682
|
0.05 Billion cells per liter
Standard Deviation 2.190
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year1,Week48,n=684
|
0.02 Billion cells per liter
Standard Deviation 2.274
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year2,Week24,n=630
|
-0.19 Billion cells per liter
Standard Deviation 2.287
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year2,Week48,n=589
|
-0.11 Billion cells per liter
Standard Deviation 2.449
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year3,Week24,n=533
|
-0.03 Billion cells per liter
Standard Deviation 2.544
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year3,Week24,n=476
|
0.06 Billion cells per liter
Standard Deviation 2.393
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year4,Week24,n=446
|
-0.01 Billion cells per liter
Standard Deviation 2.520
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year4,Week48,n=423
|
-0.06 Billion cells per liter
Standard Deviation 2.661
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year5,Week24,n=389
|
0.05 Billion cells per liter
Standard Deviation 2.430
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year5,Week48,n=360
|
-0.06 Billion cells per liter
Standard Deviation 2.463
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year6,Week24,n=306
|
0.04 Billion cells per liter
Standard Deviation 2.449
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year6,Week48,n=282
|
0.17 Billion cells per liter
Standard Deviation 2.579
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year7,Week24,n=181
|
0.12 Billion cells per liter
Standard Deviation 2.395
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year7,Week48,n=130
|
0.48 Billion cells per liter
Standard Deviation 2.354
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year8,Week24,n=52
|
0.38 Billion cells per liter
Standard Deviation 2.761
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year8,Week48,n=13
|
-0.65 Billion cells per liter
Standard Deviation 3.136
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year9,Week24,n=6
|
-0.35 Billion cells per liter
Standard Deviation 3.422
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu,Year9,Week48,n=1
|
-3.90 Billion cells per liter
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu, Exit, n=614
|
0.18 Billion cells per liter
Standard Deviation 2.650
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Leu, 8 Week Follow up,n=532
|
0.21 Billion cells per liter
Standard Deviation 2.496
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year1,Week4,n=693
|
0.093 Billion cells per liter
Standard Deviation 0.5986
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year1,Week12,n=694
|
0.107 Billion cells per liter
Standard Deviation 0.6607
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year1,Week24,n=696
|
0.066 Billion cells per liter
Standard Deviation 0.6544
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year1,Week36,n=682
|
0.119 Billion cells per liter
Standard Deviation 0.6583
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year1,Week48,n=684
|
0.048 Billion cells per liter
Standard Deviation 0.6361
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year2,Week24,n=629
|
0.051 Billion cells per liter
Standard Deviation 0.6898
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year2,Week48,n=589
|
0.067 Billion cells per liter
Standard Deviation 0.6971
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year3,Week24,n=533
|
0.057 Billion cells per liter
Standard Deviation 0.6717
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year3,Week48,n=476
|
0.038 Billion cells per liter
Standard Deviation 0.6676
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year4,Week24,n=446
|
0.054 Billion cells per liter
Standard Deviation 0.6858
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year4,Week48,n=423
|
0.067 Billion cells per liter
Standard Deviation 0.7186
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year5,Week24,n=389
|
0.023 Billion cells per liter
Standard Deviation 0.6810
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year5,Week48,n=360
|
0.078 Billion cells per liter
Standard Deviation 0.7485
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year6,Week24,n=306
|
0.147 Billion cells per liter
Standard Deviation 0.7251
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year6,Week48,n=282
|
0.168 Billion cells per liter
Standard Deviation 0.7523
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year7,Week24,n=181
|
0.175 Billion cells per liter
Standard Deviation 0.7670
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year7,Week48,n=130
|
0.169 Billion cells per liter
Standard Deviation 0.6639
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year8,Week24,n=52
|
0.300 Billion cells per liter
Standard Deviation 0.7553
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year8,Week48,n=13
|
0.052 Billion cells per liter
Standard Deviation 0.5252
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year9,Week24,n=6
|
-0.032 Billion cells per liter
Standard Deviation 0.6156
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Year9,Week48,n=1
|
-0.460 Billion cells per liter
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,Exit,n=614
|
0.128 Billion cells per liter
Standard Deviation 0.7808
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Lymp,8 Week Follow up,n=532
|
0.140 Billion cells per liter
Standard Deviation 0.7453
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year1,Week4,n=693
|
0.025 Billion cells per liter
Standard Deviation 0.2108
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year1,Week12,n=694
|
0.036 Billion cells per liter
Standard Deviation 0.2043
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year1,Week24,n=696
|
0.028 Billion cells per liter
Standard Deviation 0.2127
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year1,Week36,n=682
|
0.053 Billion cells per liter
Standard Deviation 0.2053
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year1,Week48,n=684
|
0.050 Billion cells per liter
Standard Deviation 0.2069
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year2,Week24,n=629
|
0.034 Billion cells per liter
Standard Deviation 0.1992
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year2,Week48,n=589
|
0.050 Billion cells per liter
Standard Deviation 0.2172
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year3,Week24,n=533
|
0.053 Billion cells per liter
Standard Deviation 0.2314
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year3,Week48,n=476
|
0.084 Billion cells per liter
Standard Deviation 0.1994
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year4,Week24,n=446
|
0.071 Billion cells per liter
Standard Deviation 0.2085
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year4,Week48,n=423
|
0.076 Billion cells per liter
Standard Deviation 0.2040
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year5,Week24,n=389
|
0.089 Billion cells per liter
Standard Deviation 0.2015
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year5,Week48,n=360
|
0.088 Billion cells per liter
Standard Deviation 0.2044
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year6,Week24,n=306
|
0.087 Billion cells per liter
Standard Deviation 0.2043
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year6,Week48,n=282
|
0.086 Billion cells per liter
Standard Deviation 0.2063
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year7,Week24,n=181
|
0.113 Billion cells per liter
Standard Deviation 0.2155
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year7,Week48,n=130
|
0.134 Billion cells per liter
Standard Deviation 0.2090
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year8,Week24,n=52
|
0.173 Billion cells per liter
Standard Deviation 0.2014
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year8,Week48,n=13
|
0.021 Billion cells per liter
Standard Deviation 0.1503
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year9,Week24,n=6
|
0.022 Billion cells per liter
Standard Deviation 0.1931
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono,Year9,Week48,n=1
|
-0.120 Billion cells per liter
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono, Exit,n=614
|
0.083 Billion cells per liter
Standard Deviation 0.2157
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Mono, 8 Week Follow up, n=532
|
0.084 Billion cells per liter
Standard Deviation 0.2189
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Yaer1,Week4,n=688
|
0.024 Billion cells per liter
Standard Deviation 2.0482
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neru,Year1,Week12,n=690
|
0.047 Billion cells per liter
Standard Deviation 2.1575
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year1,Week24,n=691
|
-0.059 Billion cells per liter
Standard Deviation 2.1845
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year1,Week36,n=677
|
-0.141 Billion cells per liter
Standard Deviation 2.1907
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year1,Week48,n=679
|
-0.078 Billion cells per liter
Standard Deviation 2.3164
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year2,Week24,n=624
|
-0.286 Billion cells per liter
Standard Deviation 2.2746
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year2,Week48,n=584
|
-0.230 Billion cells per liter
Standard Deviation 2.3963
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year3,Week24,n=528
|
-0.135 Billion cells per liter
Standard Deviation 2.4914
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year3,Week48,n=471
|
-0.049 Billion cells per liter
Standard Deviation 2.3683
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year4,Week24,n=446
|
-0.104 Billion cells per liter
Standard Deviation 2.3846
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year4,Week48,n=423
|
-0.160 Billion cells per liter
Standard Deviation 2.5563
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year5,Week24,n=384
|
-0.031 Billion cells per liter
Standard Deviation 2.3060
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year5,Week48,n=356
|
-0.198 Billion cells per liter
Standard Deviation 2.3952
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year6,Week24,n=306
|
-0.151 Billion cells per liter
Standard Deviation 2.3083
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year6,Week48,n=282
|
-0.060 Billion cells per liter
Standard Deviation 2.4314
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year7,Week24,n=181
|
-0.129 Billion cells per liter
Standard Deviation 2.3908
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year7,Week48,n=130
|
-0.687 Billion cells per liter
Standard Deviation 3.0412
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year8,Week24,n=52
|
-0.092 Billion cells per liter
Standard Deviation 2.3908
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year8,Week48,n=13
|
-0.687 Billion cells per liter
Standard Deviation 3.0412
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year9,Week24,n=6
|
-0.257 Billion cells per liter
Standard Deviation 2.9192
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,Year9,Week48,n=1
|
-3.300 Billion cells per liter
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu, Exit, n=609
|
-0.006 Billion cells per liter
Standard Deviation 2.5612
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Neu,8 Week Follow up,n=528
|
0.001 Billion cells per liter
Standard Deviation 2.3935
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuBF,Year1,Week4,n=4
|
0.013 Billion cells per liter
Standard Deviation 0.1473
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuBF,Year1,Week12,n=4
|
0.073 Billion cells per liter
Standard Deviation 0.1106
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuBF,Year1,Week24,n=5
|
-0.000 Billion cells per liter
Standard Deviation 0.2699
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuBF,Year1,Week36,n=4
|
0.045 Billion cells per liter
Standard Deviation 0.0465
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuBF,Year1,Week48,n=2
|
0.105 Billion cells per liter
Standard Deviation 0.1909
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuBF,Year2,Week24,n=1
|
0.120 Billion cells per liter
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuBF,Year3,Week24,n=1
|
0.070 Billion cells per liter
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuBF,Exit,n=2
|
0.465 Billion cells per liter
Standard Deviation 0.6435
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year1,Week4,n=693
|
0.021 Billion cells per liter
Standard Deviation 2.0450
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year1,Week12,n=694
|
0.051 Billion cells per liter
Standard Deviation 2.1519
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year1,Week24,n=696
|
-0.055 Billion cells per liter
Standard Deviation 2.1757
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year1,Week36,n=682
|
-0.139 Billion cells per liter
Standard Deviation 2.1819
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year1,Week48,n=684
|
-0.079 Billion cells per liter
Standard Deviation 2.3128
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year2,Week24,n=629
|
-0.289 Billion cells per liter
Standard Deviation 2.2609
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year2,Week48,n=589
|
-0.226 Billion cells per liter
Standard Deviation 2.3846
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year3,Week24,n=533
|
-0.130 Billion cells per liter
Standard Deviation 2.4736
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year3,Week48,n=476
|
-0.041 Billion cells per liter
Standard Deviation 2.3547
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year4,Week24,n=446
|
-0.097 Billion cells per liter
Standard Deviation 2.3804
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year4,Week48,n=423
|
-0.158 Billion cells per liter
Standard Deviation 2.5542
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year5,Week24,n=389
|
-0.024 Billion cells per liter
Standard Deviation 2.2893
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year5,Week48,n=360
|
-0.184 Billion cells per liter
Standard Deviation 2.3831
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year6,Week24,n=306
|
-0.147 Billion cells per liter
Standard Deviation 2.3029
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year6,Week48,n=282
|
-0.058 Billion cells per liter
Standard Deviation 2.4310
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year7,Week24,n=181
|
-0.151 Billion cells per liter
Standard Deviation 2.2248
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year7,Week48,n=130
|
0.191 Billion cells per liter
Standard Deviation 2.2514
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year8,Week24,n=52
|
-0.092 Billion cells per liter
Standard Deviation 2.3908
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year8,Week48,n=13
|
-0.687 Billion cells per liter
Standard Deviation 3.0412
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year9,Week24,n=6
|
-0.257 Billion cells per liter
Standard Deviation 2.9192
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Year9,Week48,n=1
|
-3.300 Billion cells per liter
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,Exit,n=614
|
-0.008 Billion cells per liter
Standard Deviation 2.5501
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
NeuS,8 Week Followup,n=532
|
0.007 Billion cells per liter
Standard Deviation 2.3824
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year1,Week4,n=683
|
8.1 Billion cells per liter
Standard Deviation 38.82
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year1,Week12,n=690
|
4.6 Billion cells per liter
Standard Deviation 43.63
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year1,Week24,n=687
|
-0.5 Billion cells per liter
Standard Deviation 47.73
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year1,Week36,n=680
|
-2.9 Billion cells per liter
Standard Deviation 50.25
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year1,Week48,n=677
|
-9.3 Billion cells per liter
Standard Deviation 50.81
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year2,Week24,n=631
|
-15.4 Billion cells per liter
Standard Deviation 53.80
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year2,Week48,n=583
|
-20.3 Billion cells per liter
Standard Deviation 56.39
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year3,Week24,n=526
|
-19.9 Billion cells per liter
Standard Deviation 57.88
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year3,Week48,n=476
|
-13.4 Billion cells per liter
Standard Deviation 65.16
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year4,Week24,n=441
|
-14.0 Billion cells per liter
Standard Deviation 59.05
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year4,Week48,n=420
|
-18.2 Billion cells per liter
Standard Deviation 63.80
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year5,Week24,n=388
|
-19.3 Billion cells per liter
Standard Deviation 61.49
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year5,Week48,n=360
|
-17.9 Billion cells per liter
Standard Deviation 63.36
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year6,Week24,n=305
|
-13.3 Billion cells per liter
Standard Deviation 61.54
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year6,Week48,n=282
|
-13.4 Billion cells per liter
Standard Deviation 60.89
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year7,Week24,n=181
|
-15.3 Billion cells per liter
Standard Deviation 63.95
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year7,Week48,n=130
|
-16.3 Billion cells per liter
Standard Deviation 70.75
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year8,Week24,n=52
|
-2.3 Billion cells per liter
Standard Deviation 80.69
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year8,Week48,n=13
|
-29.9 Billion cells per liter
Standard Deviation 88.66
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year9,Week24,n=6
|
-5.0 Billion cells per liter
Standard Deviation 82.67
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Year9,Week48,n=1
|
57.0 Billion cells per liter
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,Exit,n=613
|
-11.0 Billion cells per liter
Standard Deviation 64.36
|
—
|
—
|
—
|
|
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points
Plt,8Week Followup,n=530
|
-11.2 Billion cells per liter
Standard Deviation 60.57
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to 9 yearsPopulation: MITT Population
Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Hg is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year1, Week 4,n=697
|
-0.3 Gram per liter (g/L)
Standard Deviation 7.05
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year1,Week12,n=698
|
0.1 Gram per liter (g/L)
Standard Deviation 8.75
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year1,Week24,n=699
|
0.1 Gram per liter (g/L)
Standard Deviation 9.48
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year1,Week36,n=688
|
0.3 Gram per liter (g/L)
Standard Deviation 9.90
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year1,Week48,n=686
|
1.0 Gram per liter (g/L)
Standard Deviation 11.03
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year2,Week24,n=635
|
1.0 Gram per liter (g/L)
Standard Deviation 11.31
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year2,Week48,n=591
|
1.3 Gram per liter (g/L)
Standard Deviation 12.12
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year3,Week24,n=534
|
2.2 Gram per liter (g/L)
Standard Deviation 12.79
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year3,Week48,n=478
|
2.9 Gram per liter (g/L)
Standard Deviation 12.67
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year4,Week24,n=446
|
2.6 Gram per liter (g/L)
Standard Deviation 12.93
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year,Week48,n=424
|
2.4 Gram per liter (g/L)
Standard Deviation 13.59
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year5,Week24,n=390
|
2.9 Gram per liter (g/L)
Standard Deviation 12.76
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year5,Week48,n=362
|
3.2 Gram per liter (g/L)
Standard Deviation 13.26
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year6,Week24,n=306
|
2.7 Gram per liter (g/L)
Standard Deviation 13.19
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year6,Week48,n=282
|
2.3 Gram per liter (g/L)
Standard Deviation 13.83
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year7,Week24,n=181
|
2.9 Gram per liter (g/L)
Standard Deviation 14.54
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year7,Week48,n=130
|
4.0 Gram per liter (g/L)
Standard Deviation 14.66
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year8,Week24,n=52
|
1.5 Gram per liter (g/L)
Standard Deviation 14.84
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year8,Week48,n=13
|
-0.2 Gram per liter (g/L)
Standard Deviation 13.95
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year9,Week24,n=6
|
-0.7 Gram per liter (g/L)
Standard Deviation 20.67
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Year9,Week48,n=1
|
-29.0 Gram per liter (g/L)
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,Exit,n=619
|
3.2 Gram per liter (g/L)
Standard Deviation 13.90
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points
Hg,8 Week Follow up,n=534
|
2.8 Gram per liter (g/L)
Standard Deviation 13.71
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to 9 yearsPopulation: MITT Population
Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks). Change from Baseline in Hematocrit is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year1,Week4,n=697
|
0.01 Percentage of blood by volume
Standard Deviation 2.250
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year1,Week12,n=698
|
0.38 Percentage of blood by volume
Standard Deviation 2.729
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year1,Week24,n=699
|
0.75 Percentage of blood by volume
Standard Deviation 2.928
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year1,Week36,n=688
|
0.53 Percentage of blood by volume
Standard Deviation 2.954
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year1,Week48,n=686
|
0.35 Percentage of blood by volume
Standard Deviation 3.286
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year2,Week24,n=635
|
0.94 Percentage of blood by volume
Standard Deviation 3.427
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year2,Week48,n=591
|
0.78 Percentage of blood by volume
Standard Deviation 3.584
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year3,Week24,n=534
|
1.29 Percentage of blood by volume
Standard Deviation 3.828
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year3,Week48,n=478
|
1.39 Percentage of blood by volume
Standard Deviation 3.800
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year4,Week24,n=446
|
1.67 Percentage of blood by volume
Standard Deviation 3.834
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year4,Week48,n=424
|
1.15 Percentage of blood by volume
Standard Deviation 3.998
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year5,Week24,n=390
|
1.69 Percentage of blood by volume
Standard Deviation 3.776
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year5,Week48,n=362
|
1.98 Percentage of blood by volume
Standard Deviation 3.842
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year6,Week24,n=306
|
1.93 Percentage of blood by volume
Standard Deviation 3.939
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year6,Week48,n=282
|
2.07 Percentage of blood by volume
Standard Deviation 4.023
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year7,Week24,n=181
|
1.81 Percentage of blood by volume
Standard Deviation 4.251
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year7,Week48,n=130
|
2.11 Percentage of blood by volume
Standard Deviation 4.238
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year8,Week24,n=52
|
1.42 Percentage of blood by volume
Standard Deviation 4.390
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year8,Week48,n=13
|
1.48 Percentage of blood by volume
Standard Deviation 4.234
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year9,Week24,n=6
|
2.03 Percentage of blood by volume
Standard Deviation 6.001
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Year9,Week48,n=1
|
-6.00 Percentage of blood by volume
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,Exit,n=619
|
1.91 Percentage of blood by volume
Standard Deviation 4.202
|
—
|
—
|
—
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit,8 Week Follow up,n=534
|
1.85 Percentage of blood by volume
Standard Deviation 4.077
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to 9 yearsPopulation: MITT Population
Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Erythrocytes is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year1,Week4,n=697
|
-0.00 Trillions cells per liter
Standard Deviation 0.231
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year1,Week12,n=698
|
0.04 Trillions cells per liter
Standard Deviation 0.280
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year1,Week24,n=699
|
0.06 Trillions cells per liter
Standard Deviation 0.293
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year1,Week36,n=688
|
0.06 Trillions cells per liter
Standard Deviation 0.299
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year1,Week48,n=686
|
0.06 Trillions cells per liter
Standard Deviation 0.328
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year2,Week24,n=635
|
0.07 Trillions cells per liter
Standard Deviation 0.335
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year2,Week48,n=591
|
0.04 Trillions cells per liter
Standard Deviation 0.362
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year3,Week24,n=534
|
0.04 Trillions cells per liter
Standard Deviation 0.364
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year3,Week48,n=478
|
0.05 Trillions cells per liter
Standard Deviation 0.381
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year4,Week24,n=446
|
0.06 Trillions cells per liter
Standard Deviation 0.372
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year,Week48,n=424
|
0.05 Trillions cells per liter
Standard Deviation 0.379
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year5,Week24,n=390
|
0.09 Trillions cells per liter
Standard Deviation 0.375
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year5,Week48,n=362
|
0.11 Trillions cells per liter
Standard Deviation 0.383
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year6,Week24,n=306
|
0.12 Trillions cells per liter
Standard Deviation 0.396
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year6,Week48,n=282
|
0.17 Trillions cells per liter
Standard Deviation 0.408
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year7,Week24,n=181
|
0.17 Trillions cells per liter
Standard Deviation 0.415
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year7,Week48,n=130
|
0.22 Trillions cells per liter
Standard Deviation 0.387
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year8,Week24,n=52
|
0.21 Trillions cells per liter
Standard Deviation 0.375
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year8,Week48,n=13
|
0.15 Trillions cells per liter
Standard Deviation 0.207
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year9,Week24,n=6
|
0.30 Trillions cells per liter
Standard Deviation 0.374
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Year9,Week48,n=1
|
0.20 Trillions cells per liter
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,Exit,n=619
|
0.14 Trillions cells per liter
Standard Deviation 0.431
|
—
|
—
|
—
|
|
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points
Eryth,8 Week Follow up,n=534
|
0.13 Trillions cells per liter
Standard Deviation 0.411
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to 9 yearsPopulation: MITT Population
Electrolytes parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 electrolytes parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ca,CO2, Chloride, Mg, Phos, K and Na were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,8 Week Follow up,n=534
|
-0.0014 Millimoles per liter (mmol/L)
Standard Deviation 0.0909
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year1,Week4,n=701
|
-0.0 Millimoles per liter (mmol/L)
Standard Deviation 2.77
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year1,Week12,n=700
|
-0.1 Millimoles per liter (mmol/L)
Standard Deviation 2.76
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year1,Week24,n=701
|
-0.1 Millimoles per liter (mmol/L)
Standard Deviation 2.73
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year1,Week36,n=682
|
0.1 Millimoles per liter (mmol/L)
Standard Deviation 2.73
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year1,Week48,n=692
|
-0.1 Millimoles per liter (mmol/L)
Standard Deviation 2.78
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year2,Week24,n=641
|
-0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.94
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year2,Week48,n=692
|
-0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.87
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year3,Week24,n=531
|
-0.2 Millimoles per liter (mmol/L)
Standard Deviation 2.90
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year3,Week48,n=486
|
-0.4 Millimoles per liter (mmol/L)
Standard Deviation 2.75
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year4,Week24,n=438
|
-0.0 Millimoles per liter (mmol/L)
Standard Deviation 2.76
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year4,Week48,n=418
|
-0.5 Millimoles per liter (mmol/L)
Standard Deviation 3.04
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year5,Week24,n=393
|
-0.2 Millimoles per liter (mmol/L)
Standard Deviation 2.90
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year5,Week48,n=361
|
-0.8 Millimoles per liter (mmol/L)
Standard Deviation 2.82
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year6,Week24,n=303
|
-0.0 Millimoles per liter (mmol/L)
Standard Deviation 2.86
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year6,Week48,n=284
|
-0.5 Millimoles per liter (mmol/L)
Standard Deviation 2.76
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year7,Week24,n=182
|
0.2 Millimoles per liter (mmol/L)
Standard Deviation 2.78
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year7,Week48,n=130
|
0.2 Millimoles per liter (mmol/L)
Standard Deviation 2.67
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year8,Week24,n=52
|
1.0 Millimoles per liter (mmol/L)
Standard Deviation 2.78
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year8,Week48,n=13
|
0.4 Millimoles per liter (mmol/L)
Standard Deviation 3.38
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year9,Week24,n=6
|
-0.3 Millimoles per liter (mmol/L)
Standard Deviation 0.82
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Year9,Week48,n=1
|
-3.0 Millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,Exit,n=625
|
-0.3 Millimoles per liter (mmol/L)
Standard Deviation 3.00
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
CO2,8 week Follow up,n=538
|
-0.2 Millimoles per liter (mmol/L)
Standard Deviation 3.00
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year1,Week4,n=707
|
0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.33
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year1,Week12,n=704
|
0.6 Millimoles per liter (mmol/L)
Standard Deviation 2.56
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year1,Week24,n=703
|
0.6 Millimoles per liter (mmol/L)
Standard Deviation 2.42
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year1,Week36,n=684
|
0.6 Millimoles per liter (mmol/L)
Standard Deviation 2.47
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year1,Week48,n=693
|
0.4 Millimoles per liter (mmol/L)
Standard Deviation 2.44
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year2,Week24,n=643
|
0.5 Millimoles per liter (mmol/L)
Standard Deviation 2.62
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year2,Week48,n=598
|
0.5 Millimoles per liter (mmol/L)
Standard Deviation 2.81
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year3,Week24,n=535
|
0.7 Millimoles per liter (mmol/L)
Standard Deviation 3.04
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year3,Week48,n=488
|
0.6 Millimoles per liter (mmol/L)
Standard Deviation 2.73
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year4,Week24,n=439
|
0.5 Millimoles per liter (mmol/L)
Standard Deviation 2.74
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year4,Week48,n=421
|
0.7 Millimoles per liter (mmol/L)
Standard Deviation 2.84
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year5,Week24,n=392
|
0.6 Millimoles per liter (mmol/L)
Standard Deviation 2.95
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year5,Week48,n=362
|
0.6 Millimoles per liter (mmol/L)
Standard Deviation 2.77
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year6,Week24,n=304
|
1.0 Millimoles per liter (mmol/L)
Standard Deviation 2.74
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year6,Week48,n=286
|
0.8 Millimoles per liter (mmol/L)
Standard Deviation 2.67
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year7,Week24,n=183
|
0.7 Millimoles per liter (mmol/L)
Standard Deviation 2.57
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year7,Week48,n=130
|
1.1 Millimoles per liter (mmol/L)
Standard Deviation 2.73
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year8,Week24,n=52
|
1.3 Millimoles per liter (mmol/L)
Standard Deviation 2.86
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year8,Week48,n=13
|
1.2 Millimoles per liter (mmol/L)
Standard Deviation 3.54
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year9,Week24,n=6
|
3.2 Millimoles per liter (mmol/L)
Standard Deviation 1.47
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Year9,Week48,n=1
|
1.0 Millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,Exit,n=624
|
0.4 Millimoles per liter (mmol/L)
Standard Deviation 3.06
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Chloride,8 Week Follow up,n=538
|
0.4 Millimoles per liter (mmol/L)
Standard Deviation 2.82
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year1,Week4,n=707
|
-0.003 Millimoles per liter (mmol/L)
Standard Deviation 0.0583
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year1,Week 12,n=705
|
-0.006 Millimoles per liter (mmol/L)
Standard Deviation 0.0647
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year1,Week 24,n=703
|
-0.003 Millimoles per liter (mmol/L)
Standard Deviation 0.0604
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year1,Week 36,n=684
|
-0.004 Millimoles per liter (mmol/L)
Standard Deviation 0.0616
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year1,Week 48,n=693
|
0.002 Millimoles per liter (mmol/L)
Standard Deviation 0.0597
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year2,Week 24,n=643
|
0.002 Millimoles per liter (mmol/L)
Standard Deviation 0.0694
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year2,Week 48,n=598
|
0.001 Millimoles per liter (mmol/L)
Standard Deviation 0.0711
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year3,Week 24,n=535
|
0.010 Millimoles per liter (mmol/L)
Standard Deviation 0.0668
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year3,Week 48,n=488
|
0.010 Millimoles per liter (mmol/L)
Standard Deviation 0.0669
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year4,Week 24,n=439
|
0.016 Millimoles per liter (mmol/L)
Standard Deviation 0.0700
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year4,Week 48,n=421
|
0.017 Millimoles per liter (mmol/L)
Standard Deviation 0.0709
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year 5,Week 24,n=393
|
0.016 Millimoles per liter (mmol/L)
Standard Deviation 0.0673
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year 5,Week 48,n=362
|
0.021 Millimoles per liter (mmol/L)
Standard Deviation 0.0688
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year 6,Week 24,n=304
|
0.013 Millimoles per liter (mmol/L)
Standard Deviation 0.0718
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year 6,Week 48,n=286
|
0.011 Millimoles per liter (mmol/L)
Standard Deviation 0.0639
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year 7,Week 24,n=183
|
0.010 Millimoles per liter (mmol/L)
Standard Deviation 0.0692
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year 7,Week 48,n=130
|
0.013 Millimoles per liter (mmol/L)
Standard Deviation 0.0635
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year 8,Week 24,n=52
|
0.025 Millimoles per liter (mmol/L)
Standard Deviation 0.0702
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year 8,Week 48,n=13
|
0.042 Millimoles per liter (mmol/L)
Standard Deviation 0.0685
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year 9,Week 24,n=6
|
0.030 Millimoles per liter (mmol/L)
Standard Deviation 0.0613
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,Year 9,Week 48,n=1
|
0.040 Millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg, Exit,n=625
|
0.022 Millimoles per liter (mmol/L)
Standard Deviation 0.0738
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Mg,8 Week Follow up,n=539
|
0.021 Millimoles per liter (mmol/L)
Standard Deviation 0.0729
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year1, Week4,n=707
|
0.0102 Millimoles per liter (mmol/L)
Standard Deviation 0.1908
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year1, Week12,n=705
|
0.0004 Millimoles per liter (mmol/L)
Standard Deviation 0.1999
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year1, Week24,n=703
|
-0.0126 Millimoles per liter (mmol/L)
Standard Deviation 0.1964
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year1, Week 36,n=684
|
0.0101 Millimoles per liter (mmol/L)
Standard Deviation 0.1976
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year1, Week48,n=693
|
-0.0110 Millimoles per liter (mmol/L)
Standard Deviation 0.2086
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year2, Week24,n=643
|
-0.0026 Millimoles per liter (mmol/L)
Standard Deviation 0.2138
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year2, Week48,n=598
|
-0.0044 Millimoles per liter (mmol/L)
Standard Deviation 0.2062
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year3, Week24,n=535
|
-0.0109 Millimoles per liter (mmol/L)
Standard Deviation 0.2028
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year3, Week48,n=488
|
-0.0185 Millimoles per liter (mmol/L)
Standard Deviation 0.2138
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year4, Week24,n=439
|
-0.0072 Millimoles per liter (mmol/L)
Standard Deviation 0.2067
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year4, Week48,n=421
|
-0.0143 Millimoles per liter (mmol/L)
Standard Deviation 0.2118
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year5, Week24,n=393
|
-0.0199 Millimoles per liter (mmol/L)
Standard Deviation 0.2751
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year5, Week48,n=362
|
-0.0320 Millimoles per liter (mmol/L)
Standard Deviation 0.2145
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year6, Week24,n=304
|
-0.0238 Millimoles per liter (mmol/L)
Standard Deviation 0.2214
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year6, Week48,n=286
|
-0.0123 Millimoles per liter (mmol/L)
Standard Deviation 0.2113
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year 7, Week 24,n=183
|
-0.0196 Millimoles per liter (mmol/L)
Standard Deviation 0.1970
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year 7, Week 48,n=130
|
-0.0101 Millimoles per liter (mmol/L)
Standard Deviation 0.1912
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year 8, Week 24,n=52
|
-0.0041 Millimoles per liter (mmol/L)
Standard Deviation 0.2038
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year 8, Week48,n=13
|
-0.0340 Millimoles per liter (mmol/L)
Standard Deviation 0.1337
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year9, Week 24,n=6
|
-0.0803 Millimoles per liter (mmol/L)
Standard Deviation 0.0823
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Year 9, Week 48,n=1
|
0.0447 Millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, Exit, n=625
|
-0.0111 Millimoles per liter (mmol/L)
Standard Deviation 0.2243
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Phos, 8 Week Follow up,n=539
|
-0.0034 Millimoles per liter (mmol/L)
Standard Deviation 0.2233
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 1, Week 4, n=701
|
0.07 Millimoles per liter (mmol/L)
Standard Deviation 0.411
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 1, Week 12, n=700
|
0.03 Millimoles per liter (mmol/L)
Standard Deviation 0.380
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 1, Week 24, n=701
|
0.01 Millimoles per liter (mmol/L)
Standard Deviation 0.377
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 1, Week 36, n=682
|
0.04 Millimoles per liter (mmol/L)
Standard Deviation 0.387
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 1, Week 48, n=692
|
0.01 Millimoles per liter (mmol/L)
Standard Deviation 0.377
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 2, Week 24, n=641
|
0.01 Millimoles per liter (mmol/L)
Standard Deviation 0.393
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 2, Week 48, n=592
|
0.02 Millimoles per liter (mmol/L)
Standard Deviation 0.372
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 3, Week 24, n=531
|
0.05 Millimoles per liter (mmol/L)
Standard Deviation 0.401
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 3, Week 48, n=486
|
0.06 Millimoles per liter (mmol/L)
Standard Deviation 0.421
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 4, Week 24, n=438
|
0.06 Millimoles per liter (mmol/L)
Standard Deviation 0.408
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 4, Week 48, n=418
|
0.03 Millimoles per liter (mmol/L)
Standard Deviation 0.397
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 5, Week 24, n=393
|
0.08 Millimoles per liter (mmol/L)
Standard Deviation 0.427
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 5, Week 48, n=362
|
0.02 Millimoles per liter (mmol/L)
Standard Deviation 0.404
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 6, Week 24, n=303
|
0.06 Millimoles per liter (mmol/L)
Standard Deviation 0.429
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 6, Week 48, n=284
|
0.05 Millimoles per liter (mmol/L)
Standard Deviation 0.437
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 7, Week 24, n=182
|
0.05 Millimoles per liter (mmol/L)
Standard Deviation 0.445
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 7, Week 48, n=130
|
0.05 Millimoles per liter (mmol/L)
Standard Deviation 0.413
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 8, Week 24, n=52
|
-0.02 Millimoles per liter (mmol/L)
Standard Deviation 0.418
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 8, Week 48, n=13
|
-0.12 Millimoles per liter (mmol/L)
Standard Deviation 0.300
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 9, Week 24, n=6
|
0.05 Millimoles per liter (mmol/L)
Standard Deviation 0.259
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Year 9, Week 48, n=1
|
0.00 Millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, Exit, n=624
|
0.06 Millimoles per liter (mmol/L)
Standard Deviation 0.435
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
K, 8 Week Follow up, n=537
|
0.07 Millimoles per liter (mmol/L)
Standard Deviation 0.452
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 1, Week 4, n=707
|
0.1 Millimoles per liter (mmol/L)
Standard Deviation 2.07
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 1, Week 12, n=705
|
0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.25
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 1, Week 24, n=703
|
0.4 Millimoles per liter (mmol/L)
Standard Deviation 2.16
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 1, Week 36, n=684
|
0.4 Millimoles per liter (mmol/L)
Standard Deviation 2.10
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 1, Week 48, n=693
|
0.1 Millimoles per liter (mmol/L)
Standard Deviation 2.09
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 2, Week 24, n=643
|
-0.0 Millimoles per liter (mmol/L)
Standard Deviation 2.30
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 2, Week 48, n=598
|
0.1 Millimoles per liter (mmol/L)
Standard Deviation 2.63
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 3, Week 24, n=535
|
0.2 Millimoles per liter (mmol/L)
Standard Deviation 2.54
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 3, Week 48, n=488
|
0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.36
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 4, Week 24, n=439
|
0.1 Millimoles per liter (mmol/L)
Standard Deviation 2.31
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 4, Week 48, n=421
|
0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.36
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 5, Week 24, n=393
|
0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.61
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 5, Week 48, n=362
|
0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.18
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 6, Week 24, n=304
|
0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.22
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 6, Week 48, n=286
|
0.4 Millimoles per liter (mmol/L)
Standard Deviation 2.44
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 7, Week 24, n=183
|
0.1 Millimoles per liter (mmol/L)
Standard Deviation 2.22
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 7, Week 48, n=130
|
0.1 Millimoles per liter (mmol/L)
Standard Deviation 2.38
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 8, Week 24, n=52
|
0.2 Millimoles per liter (mmol/L)
Standard Deviation 2.67
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 8, Week 48, n=13
|
0.1 Millimoles per liter (mmol/L)
Standard Deviation 2.14
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 9, Week 24, n=6
|
1.0 Millimoles per liter (mmol/L)
Standard Deviation 1.79
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Year 9, Week 48, n=1
|
-3.0 Millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, Exist, n=624
|
0.1 Millimoles per liter (mmol/L)
Standard Deviation 2.55
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Na, 8 Week Follow up, n=538
|
0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.36
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year1,Week4,n=697
|
0.0030 Millimoles per liter (mmol/L)
Standard Deviation 0.0763
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year1,Week12,n=696
|
0.0020 Millimoles per liter (mmol/L)
Standard Deviation 0.0749
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year1,Week24,n=696
|
-0.0035 Millimoles per liter (mmol/L)
Standard Deviation 0.0750
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year1,Week36,n=677
|
0.0024 Millimoles per liter (mmol/L)
Standard Deviation 0.0836
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year1,Week48,n=687
|
-0.0065 Millimoles per liter (mmol/L)
Standard Deviation 0.0778
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year2,Week24,n=636
|
-0.0075 Millimoles per liter (mmol/L)
Standard Deviation 0.0764
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year2,Week48,n=587
|
-0.0091 Millimoles per liter (mmol/L)
Standard Deviation 0.0837
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year3,Week24,n=526
|
-0.0047 Millimoles per liter (mmol/L)
Standard Deviation 0.0810
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year3,Week48,n=481
|
-0.0123 Millimoles per liter (mmol/L)
Standard Deviation 0.0800
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year4,Week24,n=438
|
-0.0056 Millimoles per liter (mmol/L)
Standard Deviation 0.0771
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year,Week48,n=418
|
-0.0193 Millimoles per liter (mmol/L)
Standard Deviation 0.0805
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year5,Week24,n=387
|
-0.0129 Millimoles per liter (mmol/L)
Standard Deviation 0.0885
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year5,Week48,n=358
|
-0.0140 Millimoles per liter (mmol/L)
Standard Deviation 0.0919
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year6,Week24,n=303
|
-0.0053 Millimoles per liter (mmol/L)
Standard Deviation 0.0903
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year6,Week48,n=283
|
-0.0146 Millimoles per liter (mmol/L)
Standard Deviation 0.0870
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year7,Week24,n=182
|
-0.0076 Millimoles per liter (mmol/L)
Standard Deviation 0.0839
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year7,Week48,n=130
|
-0.0079 Millimoles per liter (mmol/L)
Standard Deviation 0.1172
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year8,Week24,n=51
|
0.0003 Millimoles per liter (mmol/L)
Standard Deviation 0.0806
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year8,Week48,n=13
|
-0.0395 Millimoles per liter (mmol/L)
Standard Deviation 0.0611
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year9,Week24,n=6
|
-0.0402 Millimoles per liter (mmol/L)
Standard Deviation 0.0336
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Year9,Week48,n=1
|
-0.0642 Millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points
Ca,Exit,n=619
|
0.0006 Millimoles per liter (mmol/L)
Standard Deviation 0.0864
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to 9 yearsPopulation: MITT Population
Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN/Cr is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year1,Week4,n=707
|
-0.2 Ratio
Standard Deviation 4.66
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year1,Week12,n=705
|
-0.3 Ratio
Standard Deviation 4.88
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/CrYear1,Week24,n=703
|
-0.7 Ratio
Standard Deviation 5.02
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year1,Week36,n=683
|
-0.5 Ratio
Standard Deviation 5.61
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year1,Week48,n=693
|
-0.2 Ratio
Standard Deviation 5.26
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year2,Week24,n=643
|
-0.1 Ratio
Standard Deviation 5.68
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year2,Week48,n=598
|
0.5 Ratio
Standard Deviation 5.55
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year3,Week24,n=535
|
1.4 Ratio
Standard Deviation 5.48
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year3,Week48,n=488
|
1.2 Ratio
Standard Deviation 5.92
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year4,Week24,n=439
|
1.4 Ratio
Standard Deviation 5.65
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year 4,Week48,n=421
|
1.0 Ratio
Standard Deviation 5.85
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year5,Week24,n=393
|
0.7 Ratio
Standard Deviation 5.51
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year5,Week48,n=362
|
1.0 Ratio
Standard Deviation 5.62
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year6,Week24,n=304
|
1.0 Ratio
Standard Deviation 5.35
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year6,Week48,n=286
|
1.3 Ratio
Standard Deviation 5.74
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year7,Week24,n=183
|
0.8 Ratio
Standard Deviation 5.68
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year7,Week48,n=130
|
1.2 Ratio
Standard Deviation 5.47
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year8,Week24,n=52
|
3.3 Ratio
Standard Deviation 4.64
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year8,Week48,n=13
|
3.5 Ratio
Standard Deviation 6.04
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year9,Week24,n=6
|
3.5 Ratio
Standard Deviation 3.08
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Year9,Week48,n=1
|
1 Ratio
Standard Deviation 2.0
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,Exit,n=625
|
0.9 Ratio
Standard Deviation 6.05
|
—
|
—
|
—
|
|
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points
BUN/Cr,8 Week Follow up,n=539
|
0.9 Ratio
Standard Deviation 5.91
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to 9 yearsPopulation: MITT Population
Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Alb and Protein were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year1,Week4,n=707
|
-0.1 Grams per liter (g/L)
Standard Deviation 2.36
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year1,Week12,n=705
|
0.2 Grams per liter (g/L)
Standard Deviation 2.67
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year1,Week24,n=703
|
0.6 Grams per liter (g/L)
Standard Deviation 3.03
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year1,Week36,n=684
|
0.7 Grams per liter (g/L)
Standard Deviation 3.23
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year1,Week48,n=693
|
1.2 Grams per liter (g/L)
Standard Deviation 3.52
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year2,Week24,n=643
|
1.2 Grams per liter (g/L)
Standard Deviation 3.49
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year2,Week48,n=598
|
1.2 Grams per liter (g/L)
Standard Deviation 3.67
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year3,Week24,n=535
|
1.2 Grams per liter (g/L)
Standard Deviation 3.78
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year3,Week48,n=488
|
1.4 Grams per liter (g/L)
Standard Deviation 4.02
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year4,Week24,n=439
|
1.7 Grams per liter (g/L)
Standard Deviation 4.02
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year 4,Week48,n=421
|
1.9 Grams per liter (g/L)
Standard Deviation 4.04
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year5,Week24,n=393
|
1.9 Grams per liter (g/L)
Standard Deviation 3.85
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year5,Week48,n=362
|
2.3 Grams per liter (g/L)
Standard Deviation 3.89
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year6,Week24,n=304
|
2.2 Grams per liter (g/L)
Standard Deviation 3.78
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year6,Week48,n=286
|
2.1 Grams per liter (g/L)
Standard Deviation 4.07
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year7,Week24,n=183
|
2.0 Grams per liter (g/L)
Standard Deviation 3.60
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year7,Week48,n=130
|
2.3 Grams per liter (g/L)
Standard Deviation 3.92
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year8,Week24,n=52
|
1.9 Grams per liter (g/L)
Standard Deviation 4.16
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year8,Week48,n=13
|
1.1 Grams per liter (g/L)
Standard Deviation 4.11
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year9,Week24,n=6
|
0.7 Grams per liter (g/L)
Standard Deviation 3.01
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Year9,Week48,n=1
|
1.0 Grams per liter (g/L)
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,Exit,n=625
|
1.8 Grams per liter (g/L)
Standard Deviation 4.74
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Alb,8 Week Follow up,n=539
|
1.7 Grams per liter (g/L)
Standard Deviation 4.66
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year1,Week4,n=707
|
-1.4 Grams per liter (g/L)
Standard Deviation 3.81
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year1,Week12,n=705
|
-2.0 Grams per liter (g/L)
Standard Deviation 4.30
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year1,Week24,n=703
|
-1.9 Grams per liter (g/L)
Standard Deviation 4.68
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year1,Week36,n=684
|
-2.3 Grams per liter (g/L)
Standard Deviation 4.75
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year1,Week48,n=693
|
-1.8 Grams per liter (g/L)
Standard Deviation 4.94
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year2,Week24,n=643
|
-2.3 Grams per liter (g/L)
Standard Deviation 5.05
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year2,Week48,n=598
|
-2.7 Grams per liter (g/L)
Standard Deviation 5.53
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year3,Week24,n=535
|
-3.1 Grams per liter (g/L)
Standard Deviation 5.62
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year3,Week48,n=488
|
-3.5 Grams per liter (g/L)
Standard Deviation 5.91
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year4,Week24,n=439
|
-3.2 Grams per liter (g/L)
Standard Deviation 5.87
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year 4,Week48,n=421
|
-3.2 Grams per liter (g/L)
Standard Deviation 6.07
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year5,Week24,n=393
|
-3.5 Grams per liter (g/L)
Standard Deviation 5.75
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year5,Week48,n=362
|
-3.6 Grams per liter (g/L)
Standard Deviation 5.78
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year6,Week24,n=304
|
-3.9 Grams per liter (g/L)
Standard Deviation 5.57
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year6,Week48,n=286
|
-4.0 Grams per liter (g/L)
Standard Deviation 5.79
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year7,Week24,n=183
|
-4.3 Grams per liter (g/L)
Standard Deviation 5.36
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year7,Week48,n=130
|
-3.9 Grams per liter (g/L)
Standard Deviation 5.32
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year8,Week24,n=52
|
-5.1 Grams per liter (g/L)
Standard Deviation 6.38
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year8,Week48,n=13
|
-4.8 Grams per liter (g/L)
Standard Deviation 5.02
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year9,Week24,n=6
|
-7.7 Grams per liter (g/L)
Standard Deviation 7.03
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Year9,Week48,n=1
|
0.0 Grams per liter (g/L)
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,Exit,n=625
|
-3.4 Grams per liter (g/L)
Standard Deviation 6.45
|
—
|
—
|
—
|
|
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points
Pro,8 Week Follow up,n=539
|
-3.7 Grams per liter (g/L)
Standard Deviation 6.42
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to 9 yearsPopulation: MITT Population
Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN and Glucose were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year1,Week4,n=707
|
0.0299 mmol/L
Standard Deviation 1.6783
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year1,Week12,n=705
|
0.0402 mmol/L
Standard Deviation 1.9768
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year1,Week24,n=703
|
-0.1443 mmol/L
Standard Deviation 1.3723
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year1,Week36,n=683
|
-0.0592 mmol/L
Standard Deviation 1.6916
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year1,Week48,n=693
|
-0.0406 mmol/L
Standard Deviation 1.5541
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year2,Week24,n=643
|
-0.0760 mmol/L
Standard Deviation 1.6652
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year2,Week48,n=598
|
0.0631 mmol/L
Standard Deviation 1.6429
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year3,Week24,n=535
|
0.0524 mmol/L
Standard Deviation 1.6850
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year3,Week48,n=488
|
-0.1013 mmol/L
Standard Deviation 1.6910
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year4,Week24,n=439
|
0.0967 mmol/L
Standard Deviation 1.9398
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year 4,Week48,n=421
|
0.0672 mmol/L
Standard Deviation 2.1393
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year5,Week24,n=393
|
-0.0291 mmol/L
Standard Deviation 2.0169
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year5,Week48,n=362
|
0.0899 mmol/L
Standard Deviation 2.0903
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year6,Week24,n=304
|
0.0959 mmol/L
Standard Deviation 1.9852
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year6,Week48,n=286
|
0.2325 mmol/L
Standard Deviation 2.2724
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year7,Week24,n=183
|
-0.0026 mmol/L
Standard Deviation 1.6623
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year7,Week48,n=130
|
0.1455 mmol/L
Standard Deviation 1.7145
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year8,Week24,n=52
|
0.5458 mmol/L
Standard Deviation 1.7299
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year8,Week48,n=13
|
0.3883 mmol/L
Standard Deviation 1.4603
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year9,Week24,n=6
|
0.1648 mmol/L
Standard Deviation 1.0466
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Year9,Week48,n=1
|
0.5700 mmol/L
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,Exit,n=625
|
0.2448 mmol/L
Standard Deviation 2.4618
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
BUN,8 Week Follow up,n=539
|
0.0822 mmol/L
Standard Deviation 2.5567
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year1,Week4,n=707
|
-0.0031 mmol/L
Standard Deviation 1.0221
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year1,Week12,n=705
|
0.0333 mmol/L
Standard Deviation 1.0627
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year1,Week24,n=702
|
-0.0396 mmol/L
Standard Deviation 1.2656
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year1,Week36,n=684
|
0.0099 mmol/L
Standard Deviation 1.0269
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year1,Week48,n=693
|
0.0010 mmol/L
Standard Deviation 1.1726
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year2,Week24,n=643
|
0.0143 mmol/L
Standard Deviation 1.3227
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year2,Week48,n=598
|
-0.0082 mmol/L
Standard Deviation 1.1352
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year3,Week24,n=535
|
-0.0159 mmol/L
Standard Deviation 1.3222
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year3,Week48,n=488
|
0.0309 mmol/L
Standard Deviation 1.1841
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year4,Week24,n=439
|
-0.0160 mmol/L
Standard Deviation 1.2213
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year 4,Week48,n=421
|
-0.0259 mmol/L
Standard Deviation 1.1936
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year5,Week24,n=393
|
0.0554 mmol/L
Standard Deviation 1.1255
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year5,Week48,n=362
|
0.0655 mmol/L
Standard Deviation 1.2946
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year6,Week24,n=303
|
0.1290 mmol/L
Standard Deviation 1.1163
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year6,Week48,n=286
|
0.2001 mmol/L
Standard Deviation 1.2411
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year7,Week24,n=183
|
0.2303 mmol/L
Standard Deviation 1.0514
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year7,Week48,n=130
|
0.2335 mmol/L
Standard Deviation 0.8346
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year8,Week24,n=52
|
0.3301 mmol/L
Standard Deviation 0.9052
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year8,Week48,n=13
|
0.1431 mmol/L
Standard Deviation 0.8115
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year9,Week24,n=6
|
0.2128 mmol/L
Standard Deviation 0.4914
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Year9,Week48,n=1
|
0.4739 mmol/L
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,Exit,n=624
|
0.1842 mmol/L
Standard Deviation 1.8723
|
—
|
—
|
—
|
|
Change From Baseline in BUN and Glucose at the Indicated Time Points
Glucose,8 Week Follow up,n=539
|
0.0338 mmol/L
Standard Deviation 1.4139
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to 9 yearsPopulation: MITT Population
Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Cr and Urate were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year1,Week36,n=684
|
0.6713 Micromoles per liter (µmol/L)
Standard Deviation 50.7341
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year1,Week4,n=707
|
1.0332 Micromoles per liter (µmol/L)
Standard Deviation 45.8504
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year1,Week12,n=704
|
0.4089 Micromoles per liter (µmol/L)
Standard Deviation 54.3182
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year1,Week24,n=703
|
-0.0510 Micromoles per liter (µmol/L)
Standard Deviation 49.2328
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year1,Week48,n=693
|
-1.5147 Micromoles per liter (µmol/L)
Standard Deviation 50.5928
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year2,Week24,n=643
|
2.7246 Micromoles per liter (µmol/L)
Standard Deviation 55.7467
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year2,Week48,n=598
|
4.1255 Micromoles per liter (µmol/L)
Standard Deviation 60.0251
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year3,Week24,n=535
|
6.7497 Micromoles per liter (µmol/L)
Standard Deviation 60.4118
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year3,Week48,n=488
|
6.9744 Micromoles per liter (µmol/L)
Standard Deviation 63.6876
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year4,Week24,n=439
|
5.9658 Micromoles per liter (µmol/L)
Standard Deviation 66.6167
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year 4,Week48,n=421
|
4.0772 Micromoles per liter (µmol/L)
Standard Deviation 67.9587
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year5,Week24,n=393
|
-0.5634 Micromoles per liter (µmol/L)
Standard Deviation 66.9130
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year5,Week48,n=362
|
-0.8979 Micromoles per liter (µmol/L)
Standard Deviation 67.3843
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year6,Week24,n=304
|
2.9530 Micromoles per liter (µmol/L)
Standard Deviation 62.3168
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year6,Week48,n=286
|
1.1244 Micromoles per liter (µmol/L)
Standard Deviation 67.3175
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year7,Week24,n=183
|
2.1521 Micromoles per liter (µmol/L)
Standard Deviation 53.0854
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year7,Week48,n=130
|
4.0062 Micromoles per liter (µmol/L)
Standard Deviation 58.3577
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year8,Week24,n=52
|
-1.1003 Micromoles per liter (µmol/L)
Standard Deviation 51.8840
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year8,Week48,n=13
|
29.2043 Micromoles per liter (µmol/L)
Standard Deviation 80.1811
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year9,Week24,n=6
|
0.2187 Micromoles per liter (µmol/L)
Standard Deviation 45.1947
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Year9,Week48,n=1
|
-69.6640 Micromoles per liter (µmol/L)
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,Exit,n=625
|
1.6479 Micromoles per liter (µmol/L)
Standard Deviation 74.4078
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Urate,8 Week Follow up,n=539
|
-2.7404 Micromoles per liter (µmol/L)
Standard Deviation 75.5887
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year1,Week4,n=707
|
0.913 Micromoles per liter (µmol/L)
Standard Deviation 14.2222
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year1,Week12,n=705
|
0.751 Micromoles per liter (µmol/L)
Standard Deviation 14.0933
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year1,Week24,n=703
|
0.823 Micromoles per liter (µmol/L)
Standard Deviation 9.5372
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year1,Week36,n=684
|
1.313 Micromoles per liter (µmol/L)
Standard Deviation 13.1107
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year1,Week48,n=693
|
0.439 Micromoles per liter (µmol/L)
Standard Deviation 11.1364
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year2,Week24,n=643
|
-0.217 Micromoles per liter (µmol/L)
Standard Deviation 13.9502
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year2,Week48,n=598
|
-0.922 Micromoles per liter (µmol/L)
Standard Deviation 13.6541
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year3,Week24,n=535
|
-3.870 Micromoles per liter (µmol/L)
Standard Deviation 17.8146
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year3,Week48,n=488
|
-4.844 Micromoles per liter (µmol/L)
Standard Deviation 17.7059
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Crea,Year4,Week24,n=439
|
-3.196 Micromoles per liter (µmol/L)
Standard Deviation 22.2874
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Crea,Year 4,Week48,n=421
|
-2.145 Micromoles per liter (µmol/L)
Standard Deviation 30.9370
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year5,Week24,n=393
|
-1.999 Micromoles per liter (µmol/L)
Standard Deviation 32.6689
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year5,Week48,n=362
|
-1.918 Micromoles per liter (µmol/L)
Standard Deviation 28.8788
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year6,Week24,n=304
|
-2.125 Micromoles per liter (µmol/L)
Standard Deviation 24.2374
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year6,Week48,n=286
|
-1.534 Micromoles per liter (µmol/L)
Standard Deviation 28.8012
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year7,Week24,n=183
|
-2.511 Micromoles per liter (µmol/L)
Standard Deviation 15.6881
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year7,Week48,n=130
|
-2.586 Micromoles per liter (µmol/L)
Standard Deviation 14.0864
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year8,Week24,n=52
|
-4.659 Micromoles per liter (µmol/L)
Standard Deviation 16.3056
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year8,Week48,n=13
|
-6.175 Micromoles per liter (µmol/L)
Standard Deviation 6.6311
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year9,Week24,n=6
|
-8.933 Micromoles per liter (µmol/L)
Standard Deviation 5.6925
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Year9,Week48,n=1
|
0.040 Micromoles per liter (µmol/L)
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,Exit,n=624
|
0.606 Micromoles per liter (µmol/L)
Standard Deviation 35.9813
|
—
|
—
|
—
|
|
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points
Cr,8 Week Follow up,n=539
|
-1.108 Micromoles per liter (µmol/L)
Standard Deviation 39.0635
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to 9 yearsPopulation: MITT Population
Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in ALT, ALP, AST, GGT and LDH were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.NA indicates standard deviation was not calculable for a single data point.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 1 Week 36, n=684
|
1.0 International Units/liter (IU/L)
Standard Deviation 64.60
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 1 Week 48, n=693
|
0.9 International Units/liter (IU/L)
Standard Deviation 35.99
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 2 Week 24, n=643
|
-0.7 International Units/liter (IU/L)
Standard Deviation 34.81
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 2 Week 48, n=598
|
0.1 International Units/liter (IU/L)
Standard Deviation 34.63
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 3 Week 24, n=535
|
-1.6 International Units/liter (IU/L)
Standard Deviation 33.88
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 3 Week 48, n=488
|
1.7 International Units/liter (IU/L)
Standard Deviation 45.42
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 4 Week 24, n=439
|
0.1 International Units/liter (IU/L)
Standard Deviation 39.13
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 4 Week 48, n=421
|
1.1 International Units/liter (IU/L)
Standard Deviation 54.41
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 5 Week 24, n=393
|
-2.0 International Units/liter (IU/L)
Standard Deviation 37.17
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 5 Week 48, n=362
|
-0.7 International Units/liter (IU/L)
Standard Deviation 43.39
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 6 Week 24, n=304
|
-1.0 International Units/liter (IU/L)
Standard Deviation 42.04
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 6 Week 48, n=286
|
1.3 International Units/liter (IU/L)
Standard Deviation 41.84
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 7 Week 24, n=183
|
1.8 International Units/liter (IU/L)
Standard Deviation 37.06
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 7 Week 48, n=130
|
-1.0 International Units/liter (IU/L)
Standard Deviation 27.86
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 8 Week 24, n=52
|
2.7 International Units/liter (IU/L)
Standard Deviation 39.90
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 8 Week 48, n=13
|
-0.3 International Units/liter (IU/L)
Standard Deviation 27.97
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 9 Week 24, n=6
|
13.3 International Units/liter (IU/L)
Standard Deviation 26.96
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 9 Week 48, n=1
|
-7.0 International Units/liter (IU/L)
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Exit, n=625
|
0.7 International Units/liter (IU/L)
Standard Deviation 41.40
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, 8 Week follow-up, n=539
|
0.2 International Units/liter (IU/L)
Standard Deviation 39.22
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 1 Week 4, n=701
|
-4.1 International Units/liter (IU/L)
Standard Deviation 77.93
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 1 Week 12, n=700
|
-6.0 International Units/liter (IU/L)
Standard Deviation 80.55
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 1 Week 24, n=701
|
-6.6 International Units/liter (IU/L)
Standard Deviation 80.09
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 1 Week 36, n=682
|
-8.8 International Units/liter (IU/L)
Standard Deviation 80.05
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 1 Week 48, n=692
|
-7.3 International Units/liter (IU/L)
Standard Deviation 81.32
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 2 Week 24, n=641
|
-9.4 International Units/liter (IU/L)
Standard Deviation 85.83
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 2 Week 48, n=592
|
-9.6 International Units/liter (IU/L)
Standard Deviation 95.52
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 3 Week 24, n=532
|
-11.8 International Units/liter (IU/L)
Standard Deviation 93.90
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 3 Week 48, n=486
|
-15.1 International Units/liter (IU/L)
Standard Deviation 94.65
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 4 Week 24, n=438
|
-16.5 International Units/liter (IU/L)
Standard Deviation 99.93
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 4 Week 48, n=418
|
-16.9 International Units/liter (IU/L)
Standard Deviation 102.11
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 5 Week 24, n=393
|
-17.5 International Units/liter (IU/L)
Standard Deviation 106.45
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 5 Week 48, n=362
|
-19.8 International Units/liter (IU/L)
Standard Deviation 108.33
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 6 Week 24, n=303
|
-21.7 International Units/liter (IU/L)
Standard Deviation 115.77
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 6 Week 48, n=284
|
-21.3 International Units/liter (IU/L)
Standard Deviation 122.62
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 7 Week 24, n=182
|
-15.2 International Units/liter (IU/L)
Standard Deviation 44.05
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 7 Week 48, n=130
|
-16.3 International Units/liter (IU/L)
Standard Deviation 42.51
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 8 Week 24, n=52
|
-14.3 International Units/liter (IU/L)
Standard Deviation 40.14
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 8 Week 48, n=13
|
-31.5 International Units/liter (IU/L)
Standard Deviation 53.04
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 9 Week 24, n=6
|
-27.2 International Units/liter (IU/L)
Standard Deviation 32.64
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Year 9 Week 48, n=1
|
-65.0 International Units/liter (IU/L)
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, Exit, n=624
|
-13.1 International Units/liter (IU/L)
Standard Deviation 90.39
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
LDH, 8 Week follow-up, n=538
|
-12.7 International Units/liter (IU/L)
Standard Deviation 95.65
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 1 Week 4, n=707
|
-0.4 International Units/liter (IU/L)
Standard Deviation 10.18
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 1 Week 12, n=705
|
-0.9 International Units/liter (IU/L)
Standard Deviation 12.31
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 1 Week 24, n=703
|
-0.9 International Units/liter (IU/L)
Standard Deviation 19.46
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 1 Week 36, n=684
|
-1.0 International Units/liter (IU/L)
Standard Deviation 15.61
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 1 Week 48, n=693
|
-0.7 International Units/liter (IU/L)
Standard Deviation 15.04
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 2 Week 24, n=643
|
0.2 International Units/liter (IU/L)
Standard Deviation 23.56
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 2 Week 48, n=598
|
2.7 International Units/liter (IU/L)
Standard Deviation 57.67
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 3 Week 24, n=535
|
-1.3 International Units/liter (IU/L)
Standard Deviation 14.40
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 3 Week 48, n=488
|
0.1 International Units/liter (IU/L)
Standard Deviation 21.21
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 4 Week 24, n=439
|
-0.1 International Units/liter (IU/L)
Standard Deviation 18.72
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 4 Week 48, n=421
|
-0.6 International Units/liter (IU/L)
Standard Deviation 17.59
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 5 Week 24, n=393
|
-1.3 International Units/liter (IU/L)
Standard Deviation 18.74
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 5 Week 48, n=362
|
-0.4 International Units/liter (IU/L)
Standard Deviation 22.72
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 6 Week 24, n=304
|
-0.2 International Units/liter (IU/L)
Standard Deviation 20.54
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 6 Week 48, n=286
|
0.9 International Units/liter (IU/L)
Standard Deviation 20.94
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 7 Week 24, n=183
|
1.3 International Units/liter (IU/L)
Standard Deviation 19.46
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 7 Week 48, n=130
|
-0.1 International Units/liter (IU/L)
Standard Deviation 16.79
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 8 Week 24, n=52
|
2.7 International Units/liter (IU/L)
Standard Deviation 31.15
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 8 Week 48, n=13
|
5.8 International Units/liter (IU/L)
Standard Deviation 33.54
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 9 Week 24, n=6
|
9.3 International Units/liter (IU/L)
Standard Deviation 27.77
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Year 9 Week 48, n=1
|
-6.0 International Units/liter (IU/L)
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, Exit, n=624
|
-0.6 International Units/liter (IU/L)
Standard Deviation 17.03
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALT, 8 Week follow-up, n=539
|
-0.8 International Units/liter (IU/L)
Standard Deviation 17.06
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 1 Week 4, n=707
|
0.0 International Units/liter (IU/L)
Standard Deviation 11.85
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 1 Week 12, n=705
|
0.5 International Units/liter (IU/L)
Standard Deviation 13.31
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 1 Week 24, n=703
|
2.1 International Units/liter (IU/L)
Standard Deviation 17.76
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 1 Week 36, n=684
|
1.7 International Units/liter (IU/L)
Standard Deviation 22.81
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 1 Week 48, n=693
|
4.6 International Units/liter (IU/L)
Standard Deviation 21.18
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 2 Week 24, n=643
|
5.1 International Units/liter (IU/L)
Standard Deviation 21.58
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 2 Week 48, n=598
|
6.1 International Units/liter (IU/L)
Standard Deviation 23.23
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 3 Week 24, n=535
|
5.9 International Units/liter (IU/L)
Standard Deviation 18.95
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 3 Week 48, n=488
|
7.3 International Units/liter (IU/L)
Standard Deviation 22.22
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 4 Week 24, n=439
|
7.2 International Units/liter (IU/L)
Standard Deviation 21.56
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 4 Week 48, n=421
|
8.1 International Units/liter (IU/L)
Standard Deviation 27.35
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 5 Week 24, n=393
|
7.2 International Units/liter (IU/L)
Standard Deviation 21.01
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 5 Week 48, n=362
|
8.5 International Units/liter (IU/L)
Standard Deviation 20.61
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 6 Week 24, n=304
|
9.4 International Units/liter (IU/L)
Standard Deviation 23.28
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 6 Week 48, n=286
|
11.5 International Units/liter (IU/L)
Standard Deviation 27.39
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 7 Week 24, n=183
|
10.9 International Units/liter (IU/L)
Standard Deviation 28.08
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 7 Week 48, n=130
|
7.5 International Units/liter (IU/L)
Standard Deviation 22.50
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 8 Week 24, n=52
|
12.9 International Units/liter (IU/L)
Standard Deviation 26.64
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 8 Week 48, n=13
|
6.1 International Units/liter (IU/L)
Standard Deviation 30.04
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 9 Week 24, n=6
|
4.2 International Units/liter (IU/L)
Standard Deviation 35.43
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Year 9 Week 48, n=1
|
12.0 International Units/liter (IU/L)
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, Exit, n=625
|
7.5 International Units/liter (IU/L)
Standard Deviation 25.35
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
ALP, 8 Week follow-up, n=539
|
6.1 International Units/liter (IU/L)
Standard Deviation 23.00
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 1 Week 4, n=701
|
-0.6 International Units/liter (IU/L)
Standard Deviation 10.56
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 1 Week 12, n=700
|
-1.3 International Units/liter (IU/L)
Standard Deviation 14.12
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 1 Week 24, n=701
|
-1.0 International Units/liter (IU/L)
Standard Deviation 20.79
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 1 Week 36, n=682
|
-1.0 International Units/liter (IU/L)
Standard Deviation 17.88
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 1 Week 48, n=692
|
-0.9 International Units/liter (IU/L)
Standard Deviation 14.38
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 2 Week 24, n=641
|
-0.4 International Units/liter (IU/L)
Standard Deviation 22.22
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 2 Week 48, n=592
|
2.9 International Units/liter (IU/L)
Standard Deviation 57.25
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 3 Week 24, n=531
|
-1.4 International Units/liter (IU/L)
Standard Deviation 13.26
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 3 Week 48, n=486
|
-0.5 International Units/liter (IU/L)
Standard Deviation 17.23
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 4 Week 24, n=438
|
-0.9 International Units/liter (IU/L)
Standard Deviation 14.60
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 4 Week 48, n=418
|
-0.7 International Units/liter (IU/L)
Standard Deviation 15.32
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 5 Week 24, n=393
|
-1.3 International Units/liter (IU/L)
Standard Deviation 16.07
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 5 Week 48, n=362
|
-0.8 International Units/liter (IU/L)
Standard Deviation 18.57
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 6 Week 24, n=303
|
-0.5 International Units/liter (IU/L)
Standard Deviation 16.95
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 6 Week 48, n=284
|
-0.2 International Units/liter (IU/L)
Standard Deviation 19.00
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 7 Week 24, n=182
|
0.6 International Units/liter (IU/L)
Standard Deviation 13.43
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 7 Week 48, n=130
|
-0.3 International Units/liter (IU/L)
Standard Deviation 10.78
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 8 Week 24, n=52
|
3.0 International Units/liter (IU/L)
Standard Deviation 33.93
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 8 Week 48, n=13
|
5.8 International Units/liter (IU/L)
Standard Deviation 24.01
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 9 Week 24, n=6
|
7.7 International Units/liter (IU/L)
Standard Deviation 19.63
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Year 9 Week 48, n=1
|
0.0 International Units/liter (IU/L)
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, Exit, n=625
|
-0.6 International Units/liter (IU/L)
Standard Deviation 18.88
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
AST, 8 Week follow-up, n=539
|
-1.1 International Units/liter (IU/L)
Standard Deviation 16.58
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 1 Week 4, n=707
|
-0.4 International Units/liter (IU/L)
Standard Deviation 23.39
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 1 Week 12, n=705
|
-1.4 International Units/liter (IU/L)
Standard Deviation 23.12
|
—
|
—
|
—
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
GGT, Year 1 Week 24, n=703
|
-0.2 International Units/liter (IU/L)
Standard Deviation 39.50
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to 9 yearsPopulation: MITT Population
Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Bili were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 1 Week 4, n=707
|
0.142 µmol/L
Standard Deviation 2.8398
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 1 Week 12, n=705
|
0.008 µmol/L
Standard Deviation 2.6383
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 1 Week 24, n=703
|
0.217 µmol/L
Standard Deviation 3.1280
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 1 Week 36, n=684
|
0.173 µmol/L
Standard Deviation 2.7566
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 1 Week 48, n=693
|
0.367 µmol/L
Standard Deviation 2.8441
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 2 Week 24, n=643
|
0.488 µmol/L
Standard Deviation 2.9346
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 2 Week 48, n=598
|
0.540 µmol/L
Standard Deviation 3.2181
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 3 Week 24, n=535
|
0.606 µmol/L
Standard Deviation 3.1612
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 3 Week 48, n=488
|
0.637 µmol/L
Standard Deviation 3.2474
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 4 Week 24, n=439
|
0.548 µmol/L
Standard Deviation 2.9773
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 4 Week 48, n=421
|
0.629 µmol/L
Standard Deviation 3.4680
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 5 Week 24, n=393
|
0.410 µmol/L
Standard Deviation 2.6931
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 5 Week 48, n=362
|
0.788 µmol/L
Standard Deviation 3.1324
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 6 Week 24, n=304
|
0.801 µmol/L
Standard Deviation 2.9946
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 6 Week 48, n=285
|
0.638 µmol/L
Standard Deviation 3.0669
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 7 Week 24, n=183
|
0.938 µmol/L
Standard Deviation 2.8158
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 7 Week 48, n=130
|
1.129 µmol/L
Standard Deviation 3.0314
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 8 Week 24, n=52
|
1.280 µmol/L
Standard Deviation 3.0707
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 8 Week 48, n=13
|
0.768 µmol/L
Standard Deviation 3.0434
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 9 Week 24, n=6
|
0.028 µmol/L
Standard Deviation 2.0182
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Year 9 Week 48, n=1
|
-2.870 µmol/L
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
Exit, n=624
|
0.573 µmol/L
Standard Deviation 3.3274
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin (Bili) Levels
8 Week follow-up, n=539
|
0.572 µmol/L
Standard Deviation 3.1052
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to 9 yearsPopulation: MITT Population
Immunoglobulin (Ig) parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 Ig parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ig G were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 1 Week 12, n=213
|
-1.571 g/L
Standard Deviation 2.2970
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 1 Week 24, n=709
|
-1.963 g/L
Standard Deviation 2.7334
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 1 Week 48, n=695
|
-2.507 g/L
Standard Deviation 3.1054
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 2 Week 24, n=482
|
-3.058 g/L
Standard Deviation 3.6147
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 2 Week 48, n=605
|
-3.232 g/L
Standard Deviation 3.7414
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 3 Week 24, n=143
|
-3.453 g/L
Standard Deviation 3.7073
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 3 Week 48, n=405
|
-3.791 g/L
Standard Deviation 4.0450
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 4 Week 24, n=146
|
-3.839 g/L
Standard Deviation 4.1411
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 4 Week 48, n=362
|
-3.794 g/L
Standard Deviation 3.8780
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 5 Week 24, n=111
|
-4.356 g/L
Standard Deviation 3.6399
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 5 Week 48, n=322
|
-4.323 g/L
Standard Deviation 4.0169
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 6 Week 24, n=71
|
-5.111 g/L
Standard Deviation 3.8846
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 6 Week 48, n=268
|
-4.697 g/L
Standard Deviation 3.9599
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 7 Week 24, n=50
|
-4.803 g/L
Standard Deviation 3.5908
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 7 Week 48, n=115
|
-4.982 g/L
Standard Deviation 4.0769
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 8 Week 24, n=18
|
-6.016 g/L
Standard Deviation 3.8450
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 8 Week 48, n=12
|
-5.520 g/L
Standard Deviation 5.1564
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Year 9 Week 48, n=1
|
0.710 g/L
Standard Deviation NA
NA indicates standard deviation was not calculable for a single data point.
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
Exit, n=627
|
-4.138 g/L
Standard Deviation 4.0025
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin G (IgG) Levels
8 Week Follow up, n=543
|
-4.325 g/L
Standard Deviation 4.0246
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 9 yearsPopulation: MITT Population
Immunogenic response was analyzed using serum samples for anti-belimumab antibody measurements in MITT population. Categories of response are Negative, Transient Positive (+) means single + response that does not occur at the final assessment, and Persistent + means + response that occurs at least 2 consecutive assessments or a single result at the final assessment. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Number of Participants With Immunogenic Response by Year
Year 0-1 Negative, n=717
|
707 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 1-2 Negative, n=684
|
656 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 2-3 Negative, n=590
|
577 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 3-4, Negative, n=502
|
498 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 4-5 Negative, n=432
|
432 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 5-6 Negative, n=336
|
336 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 6-7 Negative, n=212
|
212 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 7-8 Negative, n=64
|
64 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 8 plus Negative, n=6
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 0-1 Transient +, n=717
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 1-2 Transient + n=684
|
18 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 2-3 Transient +, n=590
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 3-4 Transient +, n=502
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 4-5 Transient +, n=432
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 5-6 Transient +, n=336
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 6-7 Transient +, n=212
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 7-8 Transient +, n=64
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 8 plus Transient +, n=6
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 0-1 Persistent+,n=717
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 1-2 Persistent+,n=684
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 2-3 Persistent+,n=590
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 3-4 Persistent+,n=502
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 4-5 Persistent+,n=432
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 5-6 Persistent+,n=336
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 6-7 Persistent+,n=212
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 7-8 Persistent+,n=64
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 8 plus Persistent+,n=6
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 0-1 Unknown, n=717
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 1-2 Unknown, n=684
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 2-3 Unknown, n=590
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 3-4 Unknown, n=502
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 4-5 Unknown, n=432
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 5-6 Unknown, n=336
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 6-7 Unknown, n=212
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 7-8 Unknown, n=64
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Immunogenic Response by Year
Year 8 plus Unknown, n=6
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 9 yearsPopulation: MITT Population
Blood samples were collected to evaluate IgG levels at Baseline and at Weeks 12, 24 and 48 during Year 1. From Year 2-9, IgG was evaluated at Week 24 and 48 ; Exit visit and at follow-up visit (up to 8 weeks post last infusion). Number of participants with IgG immunoglobulin values below the LLN at each one year interval are presented. Baseline includes 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. If a participant had more than one response within a year, then the last response within the year interval (usually the Week 48 assessment) was summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Number of Participants With IgG Values Below the Lower Limit of Normal by Year
Baseline, n=735
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With IgG Values Below the Lower Limit of Normal by Year
Year 2-3, n=620
|
22 Participants
|
—
|
—
|
—
|
|
Number of Participants With IgG Values Below the Lower Limit of Normal by Year
Year 3-4, n=514
|
19 Participants
|
—
|
—
|
—
|
|
Number of Participants With IgG Values Below the Lower Limit of Normal by Year
Year 4-5, n=442
|
15 Participants
|
—
|
—
|
—
|
|
Number of Participants With IgG Values Below the Lower Limit of Normal by Year
Year 5-6, n=345
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With IgG Values Below the Lower Limit of Normal by Year
Year 6-7, n=219
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With IgG Values Below the Lower Limit of Normal by Year
Year 7-8, n=65
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With IgG Values Below the Lower Limit of Normal by Year
More than 8 Years, n=6
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With IgG Values Below the Lower Limit of Normal by Year
Any Time Post Baseline, n=735
|
64 Participants
|
—
|
—
|
—
|
|
Number of Participants With IgG Values Below the Lower Limit of Normal by Year
Year 0-1, n=735
|
22 Participants
|
—
|
—
|
—
|
|
Number of Participants With IgG Values Below the Lower Limit of Normal by Year
Year 1-2, n=701
|
24 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 9 yearsPopulation: MITT Population
Participants who had improving SLE disease activity for at least 8 weeks, at the investigator's discretion, the steroid dose was reduced by reduction to 7.5 mg/day. If the participant continued to have stable or improving disease activity after 4 weeks on a reduced dose, then the investigator considered reducing the dose again. Baseline includes 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. Number of participants with shifts from Baseline total daily dose category by visit is summarized.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=43 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
n=227 Participants
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
n=462 Participants
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
n=1 Participants
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 1, Week 24
|
40 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 1, Week 24
|
1 Participants
|
194 Participants
|
71 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 1, Week 24
|
2 Participants
|
18 Participants
|
376 Participants
|
1 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 1, Week 24
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 1, Week 48
|
40 Participants
|
13 Participants
|
13 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 1, Week 48
|
2 Participants
|
180 Participants
|
123 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 1, Week 48
|
0 Participants
|
19 Participants
|
301 Participants
|
1 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 1, Week 48
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 2, Week 24
|
39 Participants
|
19 Participants
|
20 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 2, Week 24
|
3 Participants
|
157 Participants
|
145 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 2, Week 24
|
0 Participants
|
25 Participants
|
237 Participants
|
1 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 2, Week 24
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 3, Week 24
|
3 Participants
|
130 Participants
|
159 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 3, Week 24
|
1 Participants
|
27 Participants
|
157 Participants
|
1 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 3, Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 3, Week 48
|
31 Participants
|
20 Participants
|
30 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 3, Week 48
|
3 Participants
|
122 Participants
|
127 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 3, Week 48
|
0 Participants
|
23 Participants
|
145 Participants
|
1 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 3, Week 48
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 4, Week 24
|
28 Participants
|
17 Participants
|
34 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 4, Week 24
|
3 Participants
|
110 Participants
|
134 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 2, Week 48
|
36 Participants
|
24 Participants
|
21 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 2, Week 48
|
1 Participants
|
143 Participants
|
163 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 2, Week 48
|
1 Participants
|
26 Participants
|
195 Participants
|
1 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 2, Week 48
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 5, Week 24
|
3 Participants
|
84 Participants
|
124 Participants
|
1 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 3, Week 24
|
33 Participants
|
19 Participants
|
25 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 5, Week 24
|
1 Participants
|
16 Participants
|
99 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 5, Week 24
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 5, Week 48
|
17 Participants
|
26 Participants
|
34 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 5, Week 48
|
1 Participants
|
75 Participants
|
119 Participants
|
1 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 5, Week 48
|
1 Participants
|
13 Participants
|
85 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 5, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 6, Week 24
|
10 Participants
|
25 Participants
|
33 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 6, Week 24
|
2 Participants
|
62 Participants
|
99 Participants
|
1 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 6, Week 24
|
0 Participants
|
10 Participants
|
76 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 6, Week 24
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 6, Week 48
|
10 Participants
|
24 Participants
|
35 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 6, Week 48
|
1 Participants
|
54 Participants
|
90 Participants
|
1 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 6, Week 48
|
0 Participants
|
11 Participants
|
68 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 6, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 7, Week 24
|
4 Participants
|
10 Participants
|
29 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 7, Week 24
|
0 Participants
|
41 Participants
|
64 Participants
|
1 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 7, Week 24
|
1 Participants
|
3 Participants
|
40 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 7, Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 7, Week 48
|
4 Participants
|
3 Participants
|
24 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 7, Week 48
|
0 Participants
|
32 Participants
|
34 Participants
|
1 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 7, Week 48
|
0 Participants
|
6 Participants
|
29 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 7, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 8, Week 24
|
2 Participants
|
1 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 8, Week 24
|
0 Participants
|
13 Participants
|
15 Participants
|
1 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 8, Week 24
|
0 Participants
|
2 Participants
|
11 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 8, Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 8, Week 48
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 8, Week 48
|
0 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 8, Week 48
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 8, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 9, Week 24
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 9, Week 24
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 9, Week 24
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 9, Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 9, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 9, Week 48
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 9, Week 48
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 9, Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 4, Week 24
|
2 Participants
|
23 Participants
|
120 Participants
|
1 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 4, Week 24
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 4, Week 48
|
22 Participants
|
18 Participants
|
40 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >0 to <=7.5, Year 4, Week 48
|
3 Participants
|
100 Participants
|
129 Participants
|
1 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >7.5 to <=40, Year 4, Week 48
|
1 Participants
|
16 Participants
|
108 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose >40, Year 4, Week 48
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit
Total daily dose=0, Year 5, Week 24
|
19 Participants
|
28 Participants
|
33 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 9 yearsPopulation: MITT Population
The SLICC/ACR Damage Index was assessed every 48 weeks and at the exit visit as a measure of disease activity. It was developed to assess the accumulated damage since the onset of the disease. The number of participants with worsening in their SLICC/ACR Damage Index score compared with Baseline have been presented. Worsening was defined as a change in score (post-Baseline visit score - Baseline score) \> 0. Baseline includes 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. For years in which a participant was withdrawn from the study, the exit visit assessment was used in place of the Week 48 assessment for the year. This value was not carried forward through later years. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Outcome measures
| Measure |
Belimumab 10mg/kg IV
n=735 Participants
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
Participants With Baseline Daily Dose of >0 to <=7.5 mg
Participants were receiving a daily dose of \>0 to \<=7.5 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >7.5 to <=40 mg
Participants were receiving a daily dose of \>7.5 to \<=40 mg of prednisone and other steroids at Baseline.
|
Participants With Baseline Daily Dose of >40 mg
Participants were receiving a daily dose of \>40 mg of prednisone and other steroids at Baseline.
|
|---|---|---|---|---|
|
Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit
Year 1,Week 48, n=716
|
39 Participants
|
—
|
—
|
—
|
|
Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit
Year 2,Week 48, n=667
|
50 Participants
|
—
|
—
|
—
|
|
Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit
Year 3,Week 48, n=580
|
56 Participants
|
—
|
—
|
—
|
|
Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit
Year 4,Week 48, n=488
|
57 Participants
|
—
|
—
|
—
|
|
Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit
Year 5,Week 48, n=423
|
51 Participants
|
—
|
—
|
—
|
|
Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit
Year 6,Week 48, n=330
|
41 Participants
|
—
|
—
|
—
|
|
Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit
Year 7,Week 48, n=213
|
28 Participants
|
—
|
—
|
—
|
|
Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit
Year 8,Week 48, n=65
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit
Year 9,Week 48, n=6
|
0 Participants
|
—
|
—
|
—
|
Adverse Events
Belimumab 10mg/kg IV
Serious events: 231 serious events
Other events: 614 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Belimumab 10mg/kg IV
n=735 participants at risk
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
|---|---|
|
Nervous system disorders
Extrapyramidal disorder
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
General disorders
Face oedema
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Escherichia sepsis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Enterocolitis infectious
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Erysipelas
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Pneumonia bacterial
|
1.9%
14/735 • Number of events 16 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Cellulitis
|
1.6%
12/735 • Number of events 14 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Renal and urinary disorders
Lupus nephritis
|
1.6%
12/735 • Number of events 14 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
General disorders
Pyrexia
|
1.2%
9/735 • Number of events 10 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
9/735 • Number of events 9 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Urinary tract infection bacterial
|
1.2%
9/735 • Number of events 11 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.1%
8/735 • Number of events 9 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Pneumonia
|
1.1%
8/735 • Number of events 8 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.95%
7/735 • Number of events 7 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Appendicitis
|
0.82%
6/735 • Number of events 6 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.82%
6/735 • Number of events 7 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.68%
5/735 • Number of events 5 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.68%
5/735 • Number of events 5 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.68%
5/735 • Number of events 5 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Gastroenteritis
|
0.68%
5/735 • Number of events 5 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Herpes zoster
|
0.68%
5/735 • Number of events 5 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.68%
5/735 • Number of events 10 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.68%
5/735 • Number of events 9 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.54%
4/735 • Number of events 4 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Vascular disorders
Lupus vasculitis
|
0.54%
4/735 • Number of events 4 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
General disorders
Non-cardiac chest pain
|
0.54%
4/735 • Number of events 4 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.41%
3/735 • Number of events 3 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.41%
3/735 • Number of events 3 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Bacterial sepsis
|
0.41%
3/735 • Number of events 3 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Nervous system disorders
Headache
|
0.41%
3/735 • Number of events 3 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Vascular disorders
Hypertension
|
0.41%
3/735 • Number of events 3 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.41%
3/735 • Number of events 3 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
SLE arthritis
|
0.41%
3/735 • Number of events 3 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Septic shock
|
0.41%
3/735 • Number of events 4 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
0.41%
3/735 • Number of events 4 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.41%
3/735 • Number of events 3 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.41%
3/735 • Number of events 3 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Abscess soft tissue
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.27%
2/735 • Number of events 3 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Acute sinusitis
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Psychiatric disorders
Anxiety
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Bronchitis
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Bronchitis bacterial
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Psychiatric disorders
Depression
|
0.27%
2/735 • Number of events 4 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Diarrhoea infectious
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Immune system disorders
Drug hypersensitivity
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Escherichia infection
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Gastroenteritis viral
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Influenza
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Renal and urinary disorders
Proteinuria
|
0.27%
2/735 • Number of events 3 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Pyelonephritis acute
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Soft tissue infection
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Subcutaneous abscess
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Psychiatric disorders
Suicide attempt
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Nervous system disorders
Syncope
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Vascular disorders
Vasculitis
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Wound infection bacterial
|
0.27%
2/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Abdominal infection
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Abscess of salivary gland
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Acinetobacter bacteraemia
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Acinetobacter infection
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Amoebic dysentery
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Anal abscess
|
0.14%
1/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Cardiac disorders
Angina pectoris
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Cardiac disorders
Angina unstable
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Vascular disorders
Aortic dissection
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Vascular disorders
Aortic stenosis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Cardiac disorders
Aortic valve sclerosis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.14%
1/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Renal and urinary disorders
Bladder diverticulum
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Bronchitis viral
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Bursitis infective
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Bursitis infective staphylococcal
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Cardiac disorders
Cardiac tamponade
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Cardiac disorders
Cardiogenic shock
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Nervous system disorders
Cerebral infarction
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
General disorders
Complication associated with device
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Psychiatric disorders
Confusional state
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Cutaneous tuberculosis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
General disorders
Cyst
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Duodenitis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.14%
1/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
General disorders
Fatigue
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Food poisoning
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Fungaemia
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Hepatobiliary disorders
Gallbladder non-functioning
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Gastrointestinal fungal infection
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Gastrointestinal infection
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational diabetes
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Haematemesis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Hepatitis A
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Herpes zoster cutaneous disseminated
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Vascular disorders
Hypertensive crisis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Endocrine disorders
Hyperthyroidism
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Nervous system disorders
Hypoaesthesia
|
0.14%
1/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Endocrine disorders
Hypothyroidism
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Ileus
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Infectious colitis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Infectious pleural effusion
|
0.14%
1/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papilloma of breast
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Nervous system disorders
Ischaemic stroke
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Joint abscess
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Joint tuberculosis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Kidney infection
|
0.14%
1/735 • Number of events 3 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Nervous system disorders
Lacunar stroke
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Latent tuberculosis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract inflammation
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Lupus enteritis
|
0.14%
1/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Hepatobiliary disorders
Lupus hepatitis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Cardiac disorders
Lupus myocarditis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lupus pneumonitis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Eye disorders
Maculopathy
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Psychiatric disorders
Mania
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Meningitis aseptic
|
0.14%
1/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Nervous system disorders
Migraine
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Nervous system disorders
Myasthenia gravis
|
0.14%
1/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Nausea
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Nervous system disorders
Neuropsychiatric lupus
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Obesity
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
General disorders
Oedema peripheral
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
General disorders
Pain
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Psychiatric disorders
Panic attack
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Nervous system disorders
Paraesthesia
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Nervous system disorders
Paraplegia
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Reproductive system and breast disorders
Parovarian cyst
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Cardiac disorders
Pericardial effusion
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Cardiac disorders
Pericarditis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Cardiac disorders
Pericarditis lupus
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Vascular disorders
Peripheral ischaemia
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
General disorders
Peripheral swelling
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Peritonitis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Peritonitis bacterial
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Postoperative wound infection
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Proctitis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Pulmonary mycosis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Pyelonephritis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Renal and urinary disorders
Renal colic
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Renal and urinary disorders
Renal impairment
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Renal and urinary disorders
Renal tubular acidosis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis hypertrophic
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Salmonella bacteraemia
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Sepsis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Sialoadenitis
|
0.14%
1/735 • Number of events 2 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Cardiac disorders
Sinus tachycardia
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Skin candida
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Staphylococcal abscess
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Psychiatric disorders
Suicidal ideation
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Nervous system disorders
Tension headache
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Tracheitis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Urinary tract infection fungal
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Urosepsis
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Vascular disorders
Varicose vein
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer stage 0
|
0.14%
1/735 • Number of events 1 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
Other adverse events
| Measure |
Belimumab 10mg/kg IV
n=735 participants at risk
Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
|
|---|---|
|
Nervous system disorders
Headache
|
27.9%
205/735 • Number of events 407 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Nasopharyngitis
|
21.1%
155/735 • Number of events 396 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.5%
143/735 • Number of events 235 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.2%
134/735 • Number of events 217 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Influenza
|
18.0%
132/735 • Number of events 274 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.3%
120/735 • Number of events 176 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.9%
102/735 • Number of events 141 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Urinary tract infection bacterial
|
11.8%
87/735 • Number of events 163 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
11.4%
84/735 • Number of events 196 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.2%
82/735 • Number of events 151 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
General disorders
Pyrexia
|
9.9%
73/735 • Number of events 92 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Urinary tract infection
|
9.3%
68/735 • Number of events 99 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Vascular disorders
Hypertension
|
9.1%
67/735 • Number of events 111 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.7%
64/735 • Number of events 77 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Nausea
|
8.7%
64/735 • Number of events 97 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Nervous system disorders
Dizziness
|
8.3%
61/735 • Number of events 82 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.2%
60/735 • Number of events 78 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.2%
60/735 • Number of events 80 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
General disorders
Fatigue
|
7.6%
56/735 • Number of events 61 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.6%
56/735 • Number of events 77 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Herpes zoster
|
7.5%
55/735 • Number of events 56 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Psychiatric disorders
Insomnia
|
7.5%
55/735 • Number of events 64 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
7.3%
54/735 • Number of events 108 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Gastritis
|
7.1%
52/735 • Number of events 59 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
50/735 • Number of events 70 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Psychiatric disorders
Depression
|
6.7%
49/735 • Number of events 57 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Gastroenteritis
|
6.7%
49/735 • Number of events 59 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
49/735 • Number of events 73 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.5%
48/735 • Number of events 62 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Bronchitis bacterial
|
6.5%
48/735 • Number of events 81 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
General disorders
Oedema peripheral
|
6.4%
47/735 • Number of events 56 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Bronchitis
|
6.3%
46/735 • Number of events 64 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.1%
45/735 • Number of events 56 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Oral herpes
|
6.1%
45/735 • Number of events 89 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.0%
44/735 • Number of events 55 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
39/735 • Number of events 50 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Vascular disorders
Hypotension
|
5.3%
39/735 • Number of events 192 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Infections and infestations
Pharyngitis bacterial
|
5.3%
39/735 • Number of events 85 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
General disorders
Non-cardiac chest pain
|
5.2%
38/735 • Number of events 41 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.0%
37/735 • Number of events 47 • On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER