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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007648-85 | EudraCT Number |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This is a long-term continuation study to provide continuing treatment to subjects with SLE.
This trial is a long-term continuation study to provide continuing treatment to subjects with System Lupus Erythematosus (SLE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 1 mg/kg dose of belimumab given IV every 28 days. |
|
| 2. | Experimental | 10 mg/kg dose of belimumab given IV every 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| belimumab | Drug | Recombinant, fully human, monoclonal antibody Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AE) | 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. | Up to 9 years |
| AE Rates by System Organ Class (SOC) During the Study | 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. | Up to 9 years |
| Number of Participants With Serious Adverse Events (SAE) | 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. | Up to 9 years |
| SAE Rates by SOC During the Study | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | 1015 | Argentina | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26936891 | Background | Bruce IN, Urowitz M, van Vollenhoven R, Aranow C, Fettiplace J, Oldham M, Wilson B, Molta C, Roth D, Gordon D. Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care. Lupus. 2016 Jun;25(7):699-709. doi: 10.1177/0961203315625119. Epub 2016 Mar 1. | |
| 31302695 | Background |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Up to 9 years |
| Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | 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 | Baseline and up to 9 years |
| 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 | 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. | Baseline and up to 9 years |
| Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | 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. | Baseline and up to 9 years |
| Change From Baseline in Hematocrit at the Indicated Time Points | 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. | Baseline and up to 9 years |
| Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | 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. | Baseline and up to 9 years |
| Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | 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. | Baseline and up to 9 years |
| Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | 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. | Baseline and up to 9 years |
| Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | 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. | Baseline and up to 9 years |
| Change From Baseline in BUN and Glucose at the Indicated Time Points | 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. | Baseline and up to 9 years |
| Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | 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. | Baseline and up to 9 years |
| Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | 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. | Baseline and up to 9 years |
| Change From Baseline in Bilirubin (Bili) Levels | 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. | Baseline and up to 9 years |
| Change From Baseline in Immunoglobulin G (IgG) Levels | 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. | Baseline and up to 9 years |
| Number of Participants With Immunogenic Response by Year | 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. | Up to 9 years |
| Number of Participants With IgG Values Below the Lower Limit of Normal by Year | 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. | Up to 9 years |
| Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | 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. | Up to 9 years |
| Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit | 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. | Up to 9 years |
| Ciudad Autonoma de Buenos Aires |
| Buenos Aires |
| C1419AHN |
| Argentina |
| GSK Investigational Site | La Plata | Buenos Aires | B1904CFH, | Argentina |
| GSK Investigational Site | Rosario | Santa Fe Province | 2000 | Argentina |
| GSK Investigational Site | San Miguel de Tucumán | Tucumán Province | T4000AXL | Argentina |
| GSK Investigational Site | Buenos Aires | C1280AEB | Argentina |
| GSK Investigational Site | Buenos Aires | C1417EYG | Argentina |
| GSK Investigational Site | Ciudad Autonoma Buenos Aires | C1426AAL | Argentina |
| GSK Investigational Site | Vienna | A-1100 | Austria |
| GSK Investigational Site | Liège | 4000 | Belgium |
| GSK Investigational Site | Salvador | Estado de Bahia | 40.150-410 | Brazil |
| GSK Investigational Site | Goiânia | Goiás | 74110-120 | Brazil |
| GSK Investigational Site | Juiz de Fora | Minas Gerais | 36010-570 | Brazil |
| GSK Investigational Site | Recife | Pernambuco | 50670-420 | Brazil |
| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | 90610000 | Brazil |
| GSK Investigational Site | São Paulo | São Paulo | 04039-901 | Brazil |
| GSK Investigational Site | Campinas | 13083-888 | Brazil |
| GSK Investigational Site | Rio de Janeiro | 22411-001 | Brazil |
| GSK Investigational Site | São Paulo | 04032-060 | Brazil |
| GSK Investigational Site | São Paulo | 04266-010 | Brazil |
| GSK Investigational Site | Toronto | Ontario | M5T 2S8 | Canada |
| GSK Investigational Site | Montreal | Quebec | H3G 1A4 | Canada |
| GSK Investigational Site | Viña del Mar | Valparaiso | 2570017 | Chile |
| GSK Investigational Site | Santiago | 8431657 | Chile |
| GSK Investigational Site | Barranquilla | Colombia |
| GSK Investigational Site | Bogotá | Colombia |
| GSK Investigational Site | Bucaramanga | Colombia |
| GSK Investigational Site | MedellÃn | Colombia |
| GSK Investigational Site | Brno-Bohunice | 625 00 | Czechia |
| GSK Investigational Site | Hradec Králové | 500 05 | Czechia |
| GSK Investigational Site | Olomouc | 775 20 | Czechia |
| GSK Investigational Site | Prague | 128 50 | Czechia |
| GSK Investigational Site | Suresnes | 92150 | France |
| GSK Investigational Site | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| GSK Investigational Site | Erlangen | Bavaria | 91054 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60590 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30625 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04103 | Germany |
| GSK Investigational Site | Jena | Thuringia | 07743 | Germany |
| GSK Investigational Site | Berlin | 10117 | Germany |
| GSK Investigational Site | Berlin | 14059 | Germany |
| GSK Investigational Site | Kiel | 24105 | Germany |
| GSK Investigational Site | Chai Wan | Hong Kong |
| GSK Investigational Site | New Territories | Hong Kong |
| GSK Investigational Site | Bangalore | 560034 | India |
| GSK Investigational Site | Hyderabad, Andhra Pradesh | 500482 | India |
| GSK Investigational Site | Lucknow | 226003 | India |
| GSK Investigational Site | Secunderabad | 500003 | India |
| GSK Investigational Site | Trivandrum | 695029 | India |
| GSK Investigational Site | Beersheba | 84101 | Israel |
| GSK Investigational Site | Haifa | 31048 | Israel |
| GSK Investigational Site | Haifa | 31096 | Israel |
| GSK Investigational Site | Haifa | 34362 | Israel |
| GSK Investigational Site | Petah Tikva | 49100 | Israel |
| GSK Investigational Site | Ramat Gan | 52621 | Israel |
| GSK Investigational Site | Rehovot | 76100 | Israel |
| GSK Investigational Site | Roma | 00152 | Italy |
| GSK Investigational Site | Guadalajara | Jalisco | 44160 | Mexico |
| GSK Investigational Site | Guadalajara | Jalisco | 44280 | Mexico |
| GSK Investigational Site | México | 7760 | Mexico |
| GSK Investigational Site | San Luis Potosà City | 78240 | Mexico |
| GSK Investigational Site | Maastricht | 6229 HX | Netherlands |
| GSK Investigational Site | Rotterdam | 3015 CE | Netherlands |
| GSK Investigational Site | Rotterdam | 3083 AN | Netherlands |
| GSK Investigational Site | Surco | Lima region | Peru |
| GSK Investigational Site | Callao | Callao 2 | Peru |
| GSK Investigational Site | Lima | Lima 27 | Peru |
| GSK Investigational Site | Cebu City | 6000 | Philippines |
| GSK Investigational Site | Davao City | 8000 | Philippines |
| GSK Investigational Site | Las Piñas | 1740 | Philippines |
| GSK Investigational Site | Manila | 1000 | Philippines |
| GSK Investigational Site | Quezon City | 1102 | Philippines |
| GSK Investigational Site | Sampaloc Manila | 1008 | Philippines |
| GSK Investigational Site | Gmina Końskie | 26-200 | Poland |
| GSK Investigational Site | Ponce | 00716 | Puerto Rico |
| GSK Investigational Site | San Juan | 00936-5067 | Puerto Rico |
| GSK Investigational Site | Bucharest | 020125 | Romania |
| GSK Investigational Site | Bucharest | 020475 | Romania |
| GSK Investigational Site | Bucharest | 021392 | Romania |
| GSK Investigational Site | Cluj-Napoca | 400006 | Romania |
| GSK Investigational Site | Moscow | 115522 | Russia |
| GSK Investigational Site | Saint Petersburg | 190068 | Russia |
| GSK Investigational Site | Saint Petersburg | 191015 | Russia |
| GSK Investigational Site | Saint Petersburg | 194291 | Russia |
| GSK Investigational Site | Yaroslavl | 150003 | Russia |
| GSK Investigational Site | Yaroslavl | 150023 | Russia |
| GSK Investigational Site | Piešťany | 921 12 | Slovakia |
| GSK Investigational Site | Busan | 602-715 | South Korea |
| GSK Investigational Site | Daejeon | 302-799 | South Korea |
| GSK Investigational Site | Incheon | 400-711 | South Korea |
| GSK Investigational Site | Pusan | 602-739 | South Korea |
| GSK Investigational Site | Seoul | 137-701 | South Korea |
| GSK Investigational Site | Seoul | South Korea |
| GSK Investigational Site | Suwon, Kyonggi-do | 443-721 | South Korea |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Stockholm | SE-171 76 | Sweden |
| GSK Investigational Site | Dalin Township, Chiayi County | 662 | Taiwan |
| GSK Investigational Site | Gueishan Township,Taoyuan County | 333 | Taiwan |
| GSK Investigational Site | Hualien City | 970 | Taiwan |
| GSK Investigational Site | Kaohsiung City | 807 | Taiwan |
| GSK Investigational Site | Kaohsiung City | 813 | Taiwan |
| GSK Investigational Site | Kaohsiung City | 833 | Taiwan |
| GSK Investigational Site | Taichung | 402 | Taiwan |
| GSK Investigational Site | Taichung | 404 | Taiwan |
| GSK Investigational Site | Taichung | 40705 | Taiwan |
| GSK Investigational Site | Taipei | 100 | Taiwan |
| GSK Investigational Site | London | SE1 7EH | United Kingdom |
| GSK Investigational Site | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279. |
| 33051264 | Derived | Urowitz MB, Ohsfeldt RL, Wielage RC, Dever JJ, Zakerifar M, Asukai Y, Ramachandran S, Joshi AV. Comparative analysis of long-term organ damage in patients with systemic lupus erythematosus using belimumab versus standard therapy: a post hoc longitudinal study. Lupus Sci Med. 2020 Oct;7(1):e000412. doi: 10.1136/lupus-2020-000412. |
| COMPLETED |
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| NOT COMPLETED |
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Modified Intention to Treat (MITT) includes all participants who were enrolled in BEL112234 and were treated with at least one dose of belimumab in the continuation study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AE) | 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. | MITT Population | Posted | Number | Participants | Up to 9 years |
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| Primary | AE Rates by System Organ Class (SOC) During the Study | 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. | MITT Population | Posted | Number | Adverse events per 100 participant years | Up to 9 years | Subject years | Subject years |
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| Primary | Number of Participants With Serious Adverse Events (SAE) | 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. | MITT Population | Posted | Number | Participants | Up to 9 years |
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| Primary | SAE Rates by SOC During the Study | 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. | MITT Population | Posted | Number | Adverse events per 100 participant years | Up to 9 years | Subject years | Subject years |
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| Primary | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points | 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 | MITT Population | Posted | Mean | Standard Deviation | Seconds | Baseline and up to 9 years |
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| Primary | 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 | 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. | MITT Population | Posted | Mean | Standard Deviation | Billion cells per liter | Baseline and up to 9 years |
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| Primary | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points | 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. | MITT Population | Posted | Mean | Standard Deviation | Gram per liter (g/L) | Baseline and up to 9 years |
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| Primary | Change From Baseline in Hematocrit at the Indicated Time Points | 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. | MITT Population | Posted | Mean | Standard Deviation | Percentage of blood by volume | Baseline and up to 9 years |
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| Primary | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points | 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. | MITT Population | Posted | Mean | Standard Deviation | Trillions cells per liter | Baseline and up to 9 years |
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| Primary | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points | 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. | MITT Population | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Baseline and up to 9 years |
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| Primary | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points | 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. | MITT Population | Posted | Mean | Standard Deviation | Ratio | Baseline and up to 9 years |
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| Primary | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points | 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. | MITT Population | Posted | Mean | Standard Deviation | Grams per liter (g/L) | Baseline and up to 9 years |
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| Primary | Change From Baseline in BUN and Glucose at the Indicated Time Points | 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. | MITT Population | Posted | Mean | Standard Deviation | mmol/L | Baseline and up to 9 years |
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| Primary | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points | 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. | MITT Population | Posted | Mean | Standard Deviation | Micromoles per liter (µmol/L) | Baseline and up to 9 years |
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| Primary | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels | 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. | MITT Population | Posted | Mean | Standard Deviation | International Units/liter (IU/L) | Baseline and up to 9 years |
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| Primary | Change From Baseline in Bilirubin (Bili) Levels | 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. | MITT Population | Posted | Mean | Standard Deviation | µmol/L | Baseline and up to 9 years |
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| Primary | Change From Baseline in Immunoglobulin G (IgG) Levels | 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. | MITT Population | Posted | Mean | Standard Deviation | g/L | Baseline and up to 9 years |
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| Primary | Number of Participants With Immunogenic Response by Year | 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. | MITT Population | Posted | Number | Participants | Up to 9 years |
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| Primary | Number of Participants With IgG Values Below the Lower Limit of Normal by Year | 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. | MITT Population | Posted | Number | Participants | Up to 9 years |
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| Primary | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit | 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. | MITT Population | Posted | Number | Participants | Up to 9 years |
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| Primary | Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit | 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. | MITT Population | Posted | Number | Participants | Up to 9 years |
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On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
The MITT consisted of all randomized participants who received at least one dose of trial medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 11 | 735 | 231 | 735 | 614 | 735 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Lupus nephritis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Raynaud's phenomenon | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lupus vasculitis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bacterial pyelonephritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| SLE arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Systemic lupus erythematosus rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
| |
| Abscess soft tissue | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Wound infection bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abscess of salivary gland | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Acinetobacter bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Acinetobacter infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Amoebic dysentery | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Aortic valve sclerosis | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Benign neoplasm of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bladder diverticulum | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bursitis infective staphylococcal | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cellulitis staphylococcal | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cerebral thrombosis | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Cutaneous tuberculosis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gallbladder non-functioning | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrointestinal fungal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haemorrhagic disorder | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Herpes zoster cutaneous disseminated | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Intraductal papilloma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Joint abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Joint tuberculosis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Lacunar stroke | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Lower respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lupus enteritis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lupus hepatitis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lupus myocarditis | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lupus pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Maculopathy | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neuropsychiatric lupus | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Osteomyelitis chronic | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ovarian cyst torsion | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Parasitic gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Parovarian cyst | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pericarditis lupus | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Post procedural fistula | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary mycosis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Rectal ulcer | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Renal tubular acidosis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rhinitis hypertrophic | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Salmonella bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Skin candida | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Tubo-ovarian abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection fungal | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vulval cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pharyngitis bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C511911 | belimumab |
Not provided
Not provided
Not provided
| East Asian Heritage |
|
| South Asian Heritage |
|
| Southeast Asian Heritage |
|
| Middle East/North African Heritage |
|
| White/Caucasian/European Heritage |
|
|
| Year 1-2 ,n =701 |
|
|
| Year 2-3, n= 620 |
|
|
| Year 3-4,n= 514 |
|
|
| Year 4-5,n= 442 |
|
|
| Year 5-6, n =345 |
|
|
| Year 6-7, n= 219 |
|
|
| Year 7-8, n = 65 |
|
|
| Year 8 plus,n = 6 |
|
|
|
| Subject years |
|
|
|
|
| Subject years |
|
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| Participants |
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| Participants |
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| Units | Counts |
|---|---|
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|
Participants were receiving a daily dose of >7.5 to <=40 mg of prednisone and other steroids at Baseline.
| OG003 | Participants With Baseline Daily Dose of >40 mg | Participants were receiving a daily dose of >40 mg of prednisone and other steroids at Baseline. |
|
|
|
|