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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.
The purpose of this continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with Systemic Lupus Erythematosus (SLE), that completed study LBSL02 and benefitted from treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belimumab 10 mg/kg | Experimental | Belimumab 10 mg/kg IV over one hour every 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belimumab | Biological | Belimumab 10mg/kg IV over one hour every 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example [eg], increase in frequency or severity) of pre-existing conditions. An SAE is defined as an AE resulting in any of the following outcomes: death, is life threatening (that is, an immediate threat to life), inpatient hospitalization, prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, and is medically important. | Approximately up to 13 years |
| Adverse Event (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 treatmentemergent AEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate=100* number of events divided by participant years. Participant years were calculated as sum across all participants ([last visit of interval day minus first visit of interval day plus 1] divided by 365). | Approximately up to 13 years |
| SAE Rates by System Organ Class (SOC) During the Study | SAE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatmentemergent SAEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pretreatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate=100* number of events divided by participant years. Participant years were calculated as sum across all participants ([last visit of interval day minus first visit of interval day plus 1] divided by 365). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points | SRI response was assessed at Week 16, 32, and 48 during Year 1 to 12 and Week 16 and 32 during Year 13. Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. SRI response is defined as:>=4 point reduction from the Baseline in safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of <0.30 points from the Baseline) in Physician's Global Assessment (PGA), and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with the Baseline at the time of assessment. |
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Primary Inclusion Criteria
1. Have completed the LBSL02 trial and achieved a satisfactory response.
Primary Exclusion Criteria
Required more than 2 courses of corticosteroids for treatment of severe SLE flares in the last 5 months of LBSL02.
Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99.
Used any of the following prohibited medications during their participation in LBSL02:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24187095 | Derived | Ginzler EM, Wallace DJ, Merrill JT, Furie RA, Stohl W, Chatham WW, Weinstein A, McKay JD, McCune WJ, Zhong ZJ, Freimuth WW, Petri MA; LBSL02/99 Study Group. Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus. J Rheumatol. 2014 Feb;41(2):300-9. doi: 10.3899/jrheum.121368. Epub 2013 Nov 1. | |
| 22674457 |
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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.
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Participants who completed the parent study LBSL02 (NCT00071487) through the 24-week extension period, who received belimumab 1 milligram (mg)/kilogram (kg), 4 mg/kg, 10 mg/kg or placebo in the parent study and achieved a satisfactory response were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Belimumab 10 mg/kg IV | Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Approximately up to 13 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 8, 16, 24, 40, and 48 during Year 1 to 8; Week 8, 16, 24, and 40 during Year 9; Week 24 and 40 during Year 10; Week 48 during Year 11; Week 32 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | Baseline and approximately up to 13 years |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points | Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils segmented and platelets is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | Baseline and approximately up to 13 years |
| Change From Baseline in Erythrocytes at the Indicated Time Points | Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | Baseline and approximately up to 13 years |
| Change From Baseline in Hematocrit at the Indicated Time Points | Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | Baseline and approximately up to 13 years |
| Change From Baseline in Hemoglobin at the Indicated Time Points | Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | Baseline and approximately up to 13 years |
| Change From Baseline in Albumin and Protein at the Indicated Time Points | Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | Baseline and approximately up to 13 years |
| Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | Baseline and approximately up to 13 years |
| Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in creatinine, urate, and bilirubin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. | Baseline and approximately up to 13 years |
| Change From Baseline in BUN/Creatinine at the Indicated Time Points | Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | Baseline and approximately up to 13 years |
| Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points | Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in ALT, AP, AST, GGT and LD are summarized. Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | Baseline and approximately up to 13 years |
| Approximately up to 13 years |
| Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points | Anti-double stranded DNA levels in participants positive at Baseline were assessed at Baseline, Week 16, 32, and 48 during Year 1 to 11, Week 16 and 32 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. | Approximately up to 13 years |
| Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points | Anti-double stranded DNA levels for participants positive at Baseline were assessed at Baseline, Week 16, 32, and 48 during Year 1 to 11, Week 16 and 32 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value. | Baseline and approximately up to 13 years |
| Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points | Complement C3 and C4 levels were assessed in participants low at Baseline at Baseline, Week 16, 32, and 48 during Year 1 to 12, Week 16 and 32 during Year 13, and Exit visit. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. | Approximately up to 13 years |
| Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points | Complement C3 and C4 levels were assessed in participants low at Baseline at Baseline, Week 16, 32, and 48 during Year 1 to 12, Week 16 and 32 during Year 13, and Exit visit. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value. | Baseline and approximately up to 13 years |
| Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points | Daily prednisone dose reduction was assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13. Percentage of participants with daily prednisone dose reduced to <=7.5 mg/day from >7.5 mg/kg at the Baseline are summarized. Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. | Approximately up to 13 years |
| Absolute Serum Immunoglobulin G Values at Indicated Time Points | Serum immunoglobulin G values were assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. | Approximately up to 13 years |
| Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points | Serum immunoglobulin G values were assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value. | Baseline and approximately up to 13 years |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| GSK Investigational Site | Tucson | Arizona | 85724 | United States |
| GSK Investigational Site | La Jolla | California | 92037 | United States |
| GSK Investigational Site | Los Angeles | California | 90033 | United States |
| GSK Investigational Site | Los Angeles | California | 90048 | United States |
| GSK Investigational Site | Sacramento | California | 95817 | United States |
| GSK Investigational Site | San Jose | California | 95124 | United States |
| GSK Investigational Site | Upland | California | 91786 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80920 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20010 | United States |
| GSK Investigational Site | Aventura | Florida | 33180 | United States |
| GSK Investigational Site | Orlando | Florida | 32806-6264 | United States |
| GSK Investigational Site | Tampa | Florida | 33614 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30303 | United States |
| GSK Investigational Site | Boise | Idaho | 83704 | United States |
| GSK Investigational Site | Idaho Falls | Idaho | 83401 | United States |
| GSK Investigational Site | Chicago | Illinois | 60611 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Munster | Indiana | 46321 | United States |
| GSK Investigational Site | Kansas City | Kansas | 66160 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40202 | United States |
| GSK Investigational Site | Baton Rouge | Louisiana | 70809 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70121 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21201 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21287 | United States |
| GSK Investigational Site | Cumberland | Maryland | 21502 | United States |
| GSK Investigational Site | Wheaton | Maryland | 20902 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02111 | United States |
| GSK Investigational Site | Ann Arbor | Michigan | 48109-5542 | United States |
| GSK Investigational Site | St Louis | Missouri | 63110 | United States |
| GSK Investigational Site | Lincoln | Nebraska | 68516 | United States |
| GSK Investigational Site | Concord | New Hampshire | 03301 | United States |
| GSK Investigational Site | Dover | New Hampshire | 03820 | United States |
| GSK Investigational Site | Albany | New York | 12206 | United States |
| GSK Investigational Site | Brooklyn | New York | 11203 | United States |
| GSK Investigational Site | Great Neck | New York | 11021 | United States |
| GSK Investigational Site | Manhasset | New York | 11030 | United States |
| GSK Investigational Site | Rochester | New York | 14618 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28210 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27157 | United States |
| GSK Investigational Site | Dayton | Ohio | 45417 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| GSK Investigational Site | Tulsa | Oklahoma | 74104 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15217 | United States |
| GSK Investigational Site | Willow Grove | Pennsylvania | 19090 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Dallas | Texas | 75390-8550 | United States |
| GSK Investigational Site | Houston | Texas | 77074 | United States |
| GSK Investigational Site | Sugar Land | Texas | 77479 | United States |
| GSK Investigational Site | Arlington | Virginia | 22205-3606 | United States |
| GSK Investigational Site | Seattle | Washington | 98133 | United States |
| GSK Investigational Site | Spokane | Washington | 99204 | United States |
| GSK Investigational Site | Milwaukee | Wisconsin | 53226 | United States |
| GSK Investigational Site | Onalaska | Wisconsin | 54650 | United States |
| GSK Investigational Site | Montreal | Quebec | H3G 1A4 | Canada |
| Merrill JT, Ginzler EM, Wallace DJ, McKay JD, Lisse JR, Aranow C, Wellborne FR, Burnette M, Condemi J, Zhong ZJ, Pineda L, Klein J, Freimuth WW; LBSL02/99 Study Group. Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 Oct;64(10):3364-73. doi: 10.1002/art.34564. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Belimumab 10 mg/kg IV | Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation. |
| 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 | Modified Intent to Treat (MITT) Population: All participants who were enrolled in the study and were treated with at least one dose of belimumab in the study. | Mean | Standard Deviation | Years |
| |||||||||||||||||||||
| Sex: Female, Male | MITT Population | Count of Participants | Participants |
| ||||||||||||||||||||||
| Race/Ethnicity, Customized | MITT Population | Number | Participants |
|
| 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 the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) | An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example [eg], increase in frequency or severity) of pre-existing conditions. An SAE is defined as an AE resulting in any of the following outcomes: death, is life threatening (that is, an immediate threat to life), inpatient hospitalization, prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, and is medically important. | MITT Population. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed. | Posted | Number | Participants | Approximately up to 13 years |
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| Primary | Adverse Event (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 treatmentemergent AEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate=100* number of events divided by participant years. Participant years were calculated as sum across all participants ([last visit of interval day minus first visit of interval day plus 1] divided by 365). | MITT Population | Posted | Number | Events per 100 participant years | Approximately up to 13 years |
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| Primary | SAE Rates by System Organ Class (SOC) During the Study | SAE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatmentemergent SAEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pretreatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate=100* number of events divided by participant years. Participant years were calculated as sum across all participants ([last visit of interval day minus first visit of interval day plus 1] divided by 365). | MITT population | Posted | Number | Events per 100 participant years | Approximately up to 13 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 8, 16, 24, 40, and 48 during Year 1 to 8; Week 8, 16, 24, and 40 during Year 9; Week 24 and 40 during Year 10; Week 48 during Year 11; Week 32 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Mean | Standard Deviation | Seconds | Baseline and approximately up to 13 years |
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| Primary | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points | Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils segmented and platelets is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Mean | Standard Deviation | 10^9 per liter | Baseline and approximately up to 13 years |
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| Primary | Change From Baseline in Erythrocytes at the Indicated Time Points | Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Mean | Standard Deviation | 10^12 per liter | Baseline and approximately up to 13 years |
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| Primary | Change From Baseline in Hematocrit at the Indicated Time Points | Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Mean | Standard Deviation | Percentage of blood by volume | Baseline and approximately up to 13 years |
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| Primary | Change From Baseline in Hemoglobin at the Indicated Time Points | Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Mean | Standard Deviation | grams per liter | Baseline and approximately up to 13 years |
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| Primary | Change From Baseline in Albumin and Protein at the Indicated Time Points | Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Mean | Standard Deviation | grams/liter | Baseline and approximately up to 13 years |
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| Primary | Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points | Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Mean | Standard Deviation | millimoles per liter | Baseline and approximately up to 13 years |
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| Primary | Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points | Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in creatinine, urate, and bilirubin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. | MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Mean | Standard Deviation | micromoles per liter | Baseline and approximately up to 13 years |
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| Primary | Change From Baseline in BUN/Creatinine at the Indicated Time Points | Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Mean | Standard Deviation | Ratio | Baseline and approximately up to 13 years |
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| Primary | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points | Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in ALT, AP, AST, GGT and LD are summarized. Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. | MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Mean | Standard Deviation | International units per liter | Baseline and approximately up to 13 years |
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| Secondary | Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points | SRI response was assessed at Week 16, 32, and 48 during Year 1 to 12 and Week 16 and 32 during Year 13. Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. SRI response is defined as:>=4 point reduction from the Baseline in safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of <0.30 points from the Baseline) in Physician's Global Assessment (PGA), and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with the Baseline at the time of assessment. | MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Number | Percentage of participants | Approximately up to 13 years |
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| Secondary | Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points | Anti-double stranded DNA levels in participants positive at Baseline were assessed at Baseline, Week 16, 32, and 48 during Year 1 to 11, Week 16 and 32 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. | MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Median | Full Range | International units (IU)/milliliter (mL) | Approximately up to 13 years |
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| Secondary | Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points | Anti-double stranded DNA levels for participants positive at Baseline were assessed at Baseline, Week 16, 32, and 48 during Year 1 to 11, Week 16 and 32 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value. | MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Median | Full Range | Percent change | Baseline and approximately up to 13 years |
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| Secondary | Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points | Complement C3 and C4 levels were assessed in participants low at Baseline at Baseline, Week 16, 32, and 48 during Year 1 to 12, Week 16 and 32 during Year 13, and Exit visit. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. | MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Median | Full Range | grams per liter | Approximately up to 13 years |
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| Secondary | Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points | Complement C3 and C4 levels were assessed in participants low at Baseline at Baseline, Week 16, 32, and 48 during Year 1 to 12, Week 16 and 32 during Year 13, and Exit visit. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value. | MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Median | Full Range | Percent change | Baseline and approximately up to 13 years |
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| Secondary | Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points | Daily prednisone dose reduction was assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13. Percentage of participants with daily prednisone dose reduced to <=7.5 mg/day from >7.5 mg/kg at the Baseline are summarized. Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. | MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Number | Percentage of participants | Approximately up to 13 years |
|
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| Secondary | Absolute Serum Immunoglobulin G Values at Indicated Time Points | Serum immunoglobulin G values were assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. | MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Median | Full Range | grams per liter | Approximately up to 13 years |
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| Secondary | Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points | Serum immunoglobulin G values were assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value. | MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Posted | Median | Full Range | Percent change | Baseline and approximately up to 13 years |
|
On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).
SAEs and non-serious AEs were collected in the MITT Population.
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 10 mg/kg IV | Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation. | 182 | 296 | 293 | 296 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lupus nephritis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pericarditis lupus | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Systemic lupus erythematosus rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pelvic adhesions | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Adnexa uteri mass | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anaesthetic complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Appendicitis noninfective | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Benign intracranial hypertension | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood pressure fluctuation | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Catheter site cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cauda equina syndrome | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Central nervous system lupus | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cervical myelopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Colon cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Colpocele | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Contrast media reaction | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Cutaneous vasculitis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dry gangrene | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyskinesia oesophageal | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Endometrial cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Endometritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Extradural abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastrointestinal hypomotility | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Horner's syndrome | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertensive encephalopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Idiopathic orbital inflammation | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Implant site infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Incarcerated umbilical hernia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Lung infection pseudomonal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Lupus enteritis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Megacolon | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Microvascular coronary artery disease | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Mouth swelling | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Necrosis ischaemic | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oesophageal mass | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oesophagitis ulcerative | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Peptic ulcer perforation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Polycystic ovaries | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Restrictive cardiomyopathy | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| SLE arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Serositis | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Spinal epidural haemorrhage | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Stress at work | Social circumstances | MedDRA 18.1 | Systematic Assessment |
| |
| Stress urinary incontinence | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Suicidal behaviour | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Surgical failure | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Uterine pain | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Volvulus of small bowel | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vulvar dysplasia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| West Nile viral infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Chest X-ray | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Colonoscopy | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Nuclear magnetic resonance imaging | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| X-ray limb | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Electrocardiogram | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Butterfly rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| SLE arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bone densitometry | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Systemic lupus erythematosus rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Raynaud's phenomenon | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Computerised tomogram | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Cutaneous lupus erythematosus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Mammogram | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| X-ray of pelvis and hip | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Computerised tomogram abdomen | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nuclear magnetic resonance imaging spinal | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Spinal X-ray | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Computerised tomogram head | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 18.1 | 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 |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C511911 | belimumab |
Not provided
Not provided
Not provided
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Title | Measurements |
|---|---|
|
| AE, Year 2-3, n=276 |
|
| AE, Year 3-4, n=250 |
|
| AE, Year 4-5, n=223 |
|
| AE, Year 5-6, n=209 |
|
| AE, Year 6-7, n=192 |
|
| AE, Year 7-8, n=178 |
|
| AE, Year 8-9, n=169 |
|
| AE, Year 9-10, n=152 |
|
| AE, Year 10-11, n=131 |
|
| AE, Year 11 plus, n=88 |
|
| SAE, Any time post baseline, n=296 |
|
| SAE, Year 0-1, n=296 |
|
| SAE, Year 1-2, n=294 |
|
| SAE, Year 2-3, n=276 |
|
| SAE, Year 3-4, n=250 |
|
| SAE, Year 4-5, n=223 |
|
| SAE, Year 5-6, n=209 |
|
| SAE, Year 6-7, n=192 |
|
| SAE, Year 7-8, n=178 |
|
| SAE, Year 8-9, n=169 |
|
| SAE, Year 9-10, n=152 |
|
| SAE, Year 10-11, n=131 |
|
| SAE, Year 11 plus, n=88 |
|
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