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| ID | Type | Description | Link |
|---|---|---|---|
| HGS1006-C1124 | Other Identifier | Human Genome Sciences Inc. |
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The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and without BENLYSTA (belimumab). Participants will be enrolled into 1 of 2 cohorts: (1) BENLYSTA cohort: participants receiving or initiating BENLYSTA plus standard of care (SOC) at Baseline; (2) comparison cohort: participants not receiving BENLYSTA but receiving SOC at Baseline. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all participants will continue to be followed regardless of changes in their lupus medicines until study completion. All participants will be assessed for AESI including serious infections, opportunistic infections and other infections of interest, malignancies, selected serious psychiatric events and mortality. Data will be collected at enrollment and at 6 month intervals for 5 years. BENLYSTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benlysta | Participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who were receiving or initiated Benlysta intravenously/subcutaneously along with standard of care (SoC) therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated Benlysta within 2 months prior to enrollment) or current users (receiving Benlysta for greater than or equal to [>=2] months at enrollment) of Benlysta. |
| |
| Non-Benlysta | Participants with active, autoantibody-positive SLE who did not receive Benlysta but were receiving only SoC therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated SoC therapy within 2 months prior to enrollment) or current users (receiving SoC therapy for >=2 months at enrollment) of SoC therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benlysta | Biological | As prescribed. Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy | An adverse event (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. AESIs included mortality, malignancies (excluding non-melanoma skin cancers [NMSC]), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events. Initial exposure ITT strategy assigned exposure status of participants based on SLE medication (Benlysta or Non-Benlysta) at enrollment (Day 0). This exposure strategy analyzed all accrued AESI data during the whole follow-up period irrespective of treatment switching from Benlysta to Non-Benlysta or vice-versa. | Up to 63 Months |
| Incidence Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy | 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. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events divided by (/) Total participant-years at risk of event expressed per 100 participant-years. | Up to 12 Months |
| Incidence Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy | 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. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with active autoantibody-positive SLE.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294 | United States | ||
| GSK Investigational Site |
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A total of 171 participants from Enrolled Population (87 participants due to an inclusion or exclusion violation identified after study enrollment, and additional 74 participants who were on combination of medications that include both anti-malarials and corticosteroids [without immunosuppressant] at enrollment, 5 participants due to the lack of baseline treatment information, and 5 participants due to loss of informed consent form) were not included in Eligible Population.
As a non-interventional study, no treatments were given in this study. Data were collected during participants' routine clinical visits. A total of 3138 participants were enrolled in the study (Enrolled Population: All participants who were enrolled irrespective of whether they met the inclusion or exclusion criteria). Of these, 2967 participants were included in Eligible Population. Eligible Population included participants from the Enrolled Population who met inclusion or exclusion criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Benlysta | Participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who were receiving or initiated Benlysta intravenously/subcutaneously along with standard of care (SoC) therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated Benlysta within 2 months prior to enrollment) or current users (receiving Benlysta for greater than or equal to [>=2] months at enrollment) of Benlysta. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2022 | Feb 26, 2026 |
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| Standard of Care (SoC) Therapy | Other | As prescribed. At baseline, SoC therapy must have included an immunosuppressant. During the registry, SoC therapy could include any of the following (alone or in combination): immunosuppressants, corticosteroids, antimalarials, other biologics, investigational agents for SLE, as clinically indicated. |
|
| Up to 24 Months |
| Incidence Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy | 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. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years. | Up to 36 Months |
| Incidence Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy | 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. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years. | Up to 48 Months |
| Incidence Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy | 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. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years. | Up to 63 Months |
| Event Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. | Up to 12 Months |
| Event Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. | Up to 24 Months |
| Event Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. | Up to 36 Months |
| Event Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. | Up to 48 Months |
| Event Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. | Up to 63 Months |
| Glendale |
| Arizona |
| 85304 |
| United States |
| GSK Investigational Site | Goodyear | Arizona | 85395 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85032 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85037 | United States |
| GSK Investigational Site | Prescott | Arizona | 86305 | United States |
| GSK Investigational Site | Sun City | Arizona | 85351 | United States |
| GSK Investigational Site | Tucson | Arizona | 85704 | United States |
| GSK Investigational Site | Tucson | Arizona | 85712 | United States |
| GSK Investigational Site | Bakersfield | California | 93301 | United States |
| GSK Investigational Site | La Mesa | California | 92020 | United States |
| GSK Investigational Site | Lakewood | California | 90712 | United States |
| GSK Investigational Site | Loma Linda | California | 92354 | United States |
| GSK Investigational Site | Los Angeles | California | 90033 | United States |
| GSK Investigational Site | Los Angeles | California | 90048 | United States |
| GSK Investigational Site | Los Angeles | California | 90095 | United States |
| GSK Investigational Site | Murrieta | California | 92563 | United States |
| GSK Investigational Site | Pomona | California | 91767 | United States |
| GSK Investigational Site | Upland | California | 91786 | United States |
| GSK Investigational Site | West Hills | California | 91307 | United States |
| GSK Investigational Site | Danbury | Connecticut | 06810 | United States |
| GSK Investigational Site | New Haven | Connecticut | 06520 | United States |
| GSK Investigational Site | Orangeburg | Connecticut | 06518 | United States |
| GSK Investigational Site | Brandon | Florida | 33511 | United States |
| GSK Investigational Site | Clearwater | Florida | 33759 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33309 | United States |
| GSK Investigational Site | Jupiter | Florida | 33458 | United States |
| GSK Investigational Site | Largo | Florida | 33770 | United States |
| GSK Investigational Site | Miami | Florida | 33126 | United States |
| GSK Investigational Site | Miami | Florida | 33136 | United States |
| GSK Investigational Site | Palm Harbor | Florida | 34684 | United States |
| GSK Investigational Site | Pembroke Pines | Florida | 33026 | United States |
| GSK Investigational Site | Pensacola | Florida | 32514 | United States |
| GSK Investigational Site | Plantation | Florida | 33324 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30303 | United States |
| GSK Investigational Site | Gainesville | Georgia | 30501 | United States |
| GSK Investigational Site | Meridian | Idaho | 83642 | United States |
| GSK Investigational Site | Chicago | Illinois | 60611 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Morton Grove | Illinois | 60053 | United States |
| GSK Investigational Site | South Bend | Indiana | 46601 | United States |
| GSK Investigational Site | Baton Rouge | Louisiana | 70809 | United States |
| GSK Investigational Site | Shreveport | Louisiana | 71103 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21286 | United States |
| GSK Investigational Site | Springfield | Massachusetts | 01107 | United States |
| GSK Investigational Site | Ann Arbor | Michigan | 48109-5542 | United States |
| GSK Investigational Site | Ann Arbor | Michigan | 48917 | United States |
| GSK Investigational Site | Detroit | Michigan | 48202 | United States |
| GSK Investigational Site | Eagan | Minnesota | 55121 | United States |
| GSK Investigational Site | Edina | Minnesota | 55435 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39216 | United States |
| GSK Investigational Site | Tupelo | Mississippi | 38801 | United States |
| GSK Investigational Site | St Louis | Missouri | 63110 | United States |
| GSK Investigational Site | St Louis | Missouri | 63117 | United States |
| GSK Investigational Site | St Louis | Missouri | 63132 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68198-7680 | United States |
| GSK Investigational Site | Henderson | Nevada | 89052 | United States |
| GSK Investigational Site | Summit | New Jersey | 07901 | United States |
| GSK Investigational Site | Teaneck | New Jersey | 07666 | United States |
| GSK Investigational Site | Voorhees Township | New Jersey | 08103 | United States |
| GSK Investigational Site | Manhasset | New York | 11030 | United States |
| GSK Investigational Site | Mineola | New York | 11501 | United States |
| GSK Investigational Site | New York | New York | 10016 | United States |
| GSK Investigational Site | New York | New York | 10021 | United States |
| GSK Investigational Site | Roslyn | New York | 11576 | United States |
| GSK Investigational Site | Smithtown | New York | 11787 | United States |
| GSK Investigational Site | The Bronx | New York | 10461 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28204 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | United States |
| GSK Investigational Site | Greensboro | North Carolina | 27405 | United States |
| GSK Investigational Site | New Bern | North Carolina | 28562 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27617 | United States |
| GSK Investigational Site | Rocky Mount | North Carolina | 27804 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27157 | United States |
| GSK Investigational Site | Columbus | Ohio | 43203 | United States |
| GSK Investigational Site | Toledo | Ohio | 43614 | United States |
| GSK Investigational Site | Edmond | Oklahoma | 73013 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| GSK Investigational Site | Oklahoma City6 | Oklahoma | 73103 | United States |
| GSK Investigational Site | Tulsa | Oklahoma | 74104 | United States |
| GSK Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15224 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29406 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29425 | United States |
| GSK Investigational Site | Hixson | Tennessee | 37343-7908 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | Allen | Texas | 75013 | United States |
| GSK Investigational Site | Arlington | Texas | 22205-3606 | United States |
| GSK Investigational Site | Houston | Texas | 77004 | United States |
| GSK Investigational Site | Houston | Texas | 77034 | United States |
| GSK Investigational Site | Nassau Bay | Texas | 77058 | United States |
| GSK Investigational Site | Round Rock | Texas | 78665 | United States |
| GSK Investigational Site | San Marcos | Texas | 78666 | United States |
| GSK Investigational Site | The Woodlands | Texas | 77382 | United States |
| GSK Investigational Site | Danville | Virginia | 24541 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23502 | United States |
| GSK Investigational Site | Roanoke | Virginia | 24016 | United States |
| GSK Investigational Site | Seattle | Washington | 98133 | United States |
| GSK Investigational Site | Glendale | Wisconsin | 91204 | United States |
| GSK Investigational Site | Manitowoc | Wisconsin | 54221-1450 | United States |
| GSK Investigational Site | Buenos Aires | C1280AEB | Argentina |
| GSK Investigational Site | Ciudad autOnoma de Bueno | C1426AAL | Argentina |
| GSK Investigational Site | Paraná | 3103 | Argentina |
| GSK Investigational Site | Graz | 8036 | Austria |
| GSK Investigational Site | Linz | 4021 | Austria |
| GSK Investigational Site | Salzburg | A-5020 | Austria |
| GSK Investigational Site | Vienna | A-1100 | Austria |
| GSK Investigational Site | Leuven | 3000 | Belgium |
| GSK Investigational Site | Mississauga | Ontario | L5M 2V8 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5T 2S8 | Canada |
| GSK Investigational Site | Montreal | Quebec | H3G 1A4 | Canada |
| GSK Investigational Site | Québec | Quebec | G1V 2L9 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1G 2E8 | Canada |
| GSK Investigational Site | Bondy | 93140 | France |
| GSK Investigational Site | Lille | 59037 | France |
| GSK Investigational Site | Paris | 75571 | France |
| GSK Investigational Site | Strasbourg | 67098 | France |
| GSK Investigational Site | Bad Bramstedt | 24576 | Germany |
| GSK Investigational Site | Bad Nauheim | 61231 | Germany |
| GSK Investigational Site | Cologne | 51149 | Germany |
| GSK Investigational Site | Dresden | 01067 | Germany |
| GSK Investigational Site | Düsseldorf | 40225 | Germany |
| GSK Investigational Site | Elmshorn | 25335 | Germany |
| GSK Investigational Site | Halle | 06120 | Germany |
| GSK Investigational Site | Hamburg | 22767 | Germany |
| GSK Investigational Site | Heidelberg | 69121 | Germany |
| GSK Investigational Site | Jena | 07740 | Germany |
| GSK Investigational Site | Kiel | 23538 | Germany |
| GSK Investigational Site | Kiel | 24105 | Germany |
| GSK Investigational Site | Leipzig | 04129 | Germany |
| GSK Investigational Site | Mainz | 55131 | Germany |
| GSK Investigational Site | Püttlingen | 66346 | Germany |
| GSK Investigational Site | Stuttgart | 70376 | Germany |
| GSK Investigational Site | Ashkelon | 78278 | Israel |
| GSK Investigational Site | Haifa | 31048 | Israel |
| GSK Investigational Site | Haifa | 31096 | Israel |
| GSK Investigational Site | Jerusalem | 91120 | Israel |
| GSK Investigational Site | Nahariya | 22100 | Israel |
| GSK Investigational Site | Petah Tikva | 49100 | Israel |
| GSK Investigational Site | Ramat Gan | 52621 | Israel |
| GSK Investigational Site | Rehovot | 76100 | Israel |
| GSK Investigational Site | Tel Aviv | 64239 | Israel |
| GSK Investigational Site | Brescia | 25125 | Italy |
| GSK Investigational Site | Milan | 20122 | Italy |
| GSK Investigational Site | Milan | 20132 | Italy |
| GSK Investigational Site | Milan | 20157 | Italy |
| GSK Investigational Site | Padova | 35128 | Italy |
| GSK Investigational Site | Pisa | 56126 | Italy |
| GSK Investigational Site | Roma | 00161 | Italy |
| GSK Investigational Site | Roma | 00168 | Italy |
| GSK Investigational Site | Siena | 53100 | Italy |
| GSK Investigational Site | Udine | 33100 | Italy |
| GSK Investigational Site | Lisbon | 1069-166 | Portugal |
| GSK Investigational Site | Bratislava | 826 06 | Slovakia |
| GSK Investigational Site | Košice | 040 11 | Slovakia |
| GSK Investigational Site | Košice | 97401 | Slovakia |
| GSK Investigational Site | Piešťany | 921 01 | Slovakia |
| GSK Investigational Site | Piešťany | 921 12 | Slovakia |
| GSK Investigational Site | A Coruña | 15006 | Spain |
| GSK Investigational Site | Alicante | 03010 | Spain |
| GSK Investigational Site | BaracaldoVizcaya | 48903 | Spain |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Barcelona | 08907 | Spain |
| GSK Investigational Site | Getafe | 28905 | Spain |
| GSK Investigational Site | Las Palmas | 35020 | Spain |
| GSK Investigational Site | Madrid | 28007 | Spain |
| GSK Investigational Site | Madrid | 28041 | Spain |
| GSK Investigational Site | Madrid | 28222 | Spain |
| GSK Investigational Site | Murcia | 30120 | Spain |
| GSK Investigational Site | Santander | 39008 | Spain |
| GSK Investigational Site | Toledo | 45111 | Spain |
| GSK Investigational Site | Valencia | 46017 | Spain |
| GSK Investigational Site | Valencia | 46026 | Spain |
| GSK Investigational Site | Valladolid | 47012 | Spain |
| GSK Investigational Site | VigoPontevedra | 36200 | Spain |
| GSK Investigational Site | Villajoyosa | 3570 | Spain |
| GSK Investigational Site | Stockholm | SE-171 76 | Sweden |
| FG001 | Non-Benlysta | Participants with active, autoantibody-positive SLE who did not receive Benlysta but were receiving only SoC therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated SoC therapy within 2 months prior to enrollment) or current users (receiving SoC therapy for >=2 months at enrollment) of SoC therapy. |
|
| Evaluable Population | Evaluable Population included participants in the Eligible Population with a collection of enrollment data and at least one post-baseline assessment. |
|
| Participants With Missing End-of-Study (EOS) Forms |
|
| COMPLETED | Participants with missing EOS forms were considered in 'Completed' because they contributed to all analyses presented. |
|
| NOT COMPLETED |
|
|
Eligible Population included participants in the Enrolled Population who met inclusion or exclusion criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Benlysta | Participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who were receiving or initiated Benlysta intravenously/subcutaneously along with standard of care (SoC) therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated Benlysta within 2 months prior to enrollment) or current users (receiving Benlysta for greater than or equal to [>=2] months at enrollment) of Benlysta. |
| BG001 | Non-Benlysta | Participants with active, autoantibody-positive SLE who did not receive Benlysta but were receiving only SoC therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated SoC therapy within 2 months prior to enrollment) or current users (receiving SoC therapy for >=2 months at enrollment) of SoC therapy. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | YEARS |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | 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 Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy | An adverse event (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. AESIs included mortality, malignancies (excluding non-melanoma skin cancers [NMSC]), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events. Initial exposure ITT strategy assigned exposure status of participants based on SLE medication (Benlysta or Non-Benlysta) at enrollment (Day 0). This exposure strategy analyzed all accrued AESI data during the whole follow-up period irrespective of treatment switching from Benlysta to Non-Benlysta or vice-versa. | Evaluable Population included participants in the Eligible Population with a collection of enrollment data and at least one post-baseline assessment. | Posted | Count of Participants | Participants | Up to 63 Months |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Incidence Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy | 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. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events divided by (/) Total participant-years at risk of event expressed per 100 participant-years. | Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0). | Posted | Number | 95% Confidence Interval | Events per 100 participant-years | Up to 12 Months |
| |||||||||||||||||||||||||||||||||||||
| Primary | Incidence Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy | 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. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years. | Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0). | Posted | Number | 95% Confidence Interval | Events per 100 participant-years | Up to 24 Months |
| |||||||||||||||||||||||||||||||||||||
| Primary | Incidence Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy | 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. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years. | Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0). | Posted | Number | 95% Confidence Interval | Events per 100 participant-years | Up to 36 Months |
| |||||||||||||||||||||||||||||||||||||
| Primary | Incidence Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy | 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. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years. | Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0). | Posted | Number | 95% Confidence Interval | Events per 100 participant-years | Up to 48 Months |
| |||||||||||||||||||||||||||||||||||||
| Primary | Incidence Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy | 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. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years. | Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0). | Posted | Number | 95% Confidence Interval | Events per 100 participant-years | Up to 63 Months |
| |||||||||||||||||||||||||||||||||||||
| Primary | Event Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. | Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0). | Posted | Number | 95% Confidence Interval | Events per 100 participant-years | Up to 12 Months |
| |||||||||||||||||||||||||||||||||||||
| Primary | Event Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. | Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0). | Posted | Number | 95% Confidence Interval | Events per 100 participant-years | Up to 24 Months |
| |||||||||||||||||||||||||||||||||||||
| Primary | Event Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. | Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0). | Posted | Number | 95% Confidence Interval | Events per 100 participant-years | Up to 36 Months |
| |||||||||||||||||||||||||||||||||||||
| Primary | Event Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. | Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0). | Posted | Number | 95% Confidence Interval | Events per 100 participant-years | Up to 48 Months |
| |||||||||||||||||||||||||||||||||||||
| Primary | Event Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. | Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0). | Posted | Number | 95% Confidence Interval | Events per 100 participant-years | Up to 63 Months |
|
From enrollment (Day 0) up to 63 Months
Evaluable Population included participants in the Eligible Population with a collection of enrollment data and at least one post-baseline assessment.
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 | Benlysta | Participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who were receiving or initiated Benlysta intravenously/subcutaneously along with standard of care (SoC) therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated Benlysta within 2 months prior to enrollment) or current users (receiving Benlysta for greater than or equal to [>=2] months at enrollment) of Benlysta. | 48 | 1,924 | 248 | 1,924 | 81 | 1,924 |
| EG001 | Non-Benlysta | Participants with active, autoantibody-positive SLE who did not receive Benlysta but were receiving only SoC therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated SoC therapy within 2 months prior to enrollment) or current users (receiving SoC therapy for >=2 months at enrollment) of SoC therapy. | 29 | 881 | 108 | 881 | 32 | 881 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Anal cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Breast cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Colon cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Epstein-Barr virus associated lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Extranodal marginal zone B-cell lymphoma (MALT type) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Fallopian tube cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Glioblastoma multiforme | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Large granular lymphocytosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Marginal zone lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Paget's disease of the vulva | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Triple negative breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Candida sepsis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Cutaneous nocardiosis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Disseminated mycobacterium avium complex infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Herpes zoster cutaneous disseminated | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Herpes zoster meningitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Herpes zoster meningoencephalitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Mycobacterium fortuitum infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Nocardia sepsis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Osteomyelitis bacterial | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Acute hepatitis B | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Genital herpes zoster | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Abscess jaw | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Avian influenza | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Babesiosis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Bacterial colitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Blister infected | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Breast cellulitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Cellulitis staphylococcal | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Corneal abscess | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Dermo-hypodermitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Endometritis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Enterobacter infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Enterobacter pneumonia | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Escherichia pyelonephritis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Gastroenteritis bacterial | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Herpes simplex meningitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Infected lymphocele | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Otitis externa fungal | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Perihepatitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Pilonidal disease | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Plasmodium falciparum infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Retroperitoneal abscess | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Tubo-ovarian abscess | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Vulval abscess | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Traumatic ulcer | Injury, poisoning and procedural complications | MedDRA v27.1 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v27.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA v27.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA v27.1 | Systematic Assessment |
| |
| Adjustment disorder with mixed anxiety and depressed mood | Psychiatric disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Generalised anxiety disorder | Psychiatric disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Suicidal behaviour | Psychiatric disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Acute right ventricular failure | Cardiac disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Intestinal infarction | Gastrointestinal disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA v27.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA v27.1 | Systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic lesion | Hepatobiliary disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Gastroenteritis Escherichia coli | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Herpes zoster cutaneous disseminated | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Listeriosis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Mycobacterium kansasii infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
| |
| Atypical fibroxanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Extranodal marginal zone B-cell lymphoma (MALT type) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Malignant melanoma stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
| |
| Tubular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Systematic Assessment |
|
EOS forms were missing for 13 participants from the Eligible Population. However, as these participants contributed data to all analyses presented, they were included under 'Completed' participants.
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 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2025 | Feb 27, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C511911 | belimumab |
| D059039 | Standard of Care |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black-African American or African Heritage |
|
| Alaska Native or American Indian from North/Central/South America |
|
| Native Hawaiian or Other Pacific Islander |
|
| Multiracial |
|
| Unknown |
|
| Serious infections |
|
| Opportunistic infections |
|
| Other infections of special interest |
|
| NMSC |
|
| Serious psychiatric events |
|
| OG001 | Non-Benlysta | Participants with active, autoantibody-positive SLE who did not receive Benlysta but were receiving only SoC therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated SoC therapy within 2 months prior to enrollment) or current users (receiving SoC therapy for >=2 months at enrollment) of SoC therapy. |
|
|
| OG001 | Non-Benlysta | Participants with active, autoantibody-positive SLE who did not receive Benlysta but were receiving only SoC therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated SoC therapy within 2 months prior to enrollment) or current users (receiving SoC therapy for >=2 months at enrollment) of SoC therapy. |
|
|
| OG001 | Non-Benlysta | Participants with active, autoantibody-positive SLE who did not receive Benlysta but were receiving only SoC therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated SoC therapy within 2 months prior to enrollment) or current users (receiving SoC therapy for >=2 months at enrollment) of SoC therapy. |
|
|
| OG001 | Non-Benlysta | Participants with active, autoantibody-positive SLE who did not receive Benlysta but were receiving only SoC therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated SoC therapy within 2 months prior to enrollment) or current users (receiving SoC therapy for >=2 months at enrollment) of SoC therapy. |
|
|
| OG001 | Non-Benlysta | Participants with active, autoantibody-positive SLE who did not receive Benlysta but were receiving only SoC therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated SoC therapy within 2 months prior to enrollment) or current users (receiving SoC therapy for >=2 months at enrollment) of SoC therapy. |
|
|
| OG001 | Non-Benlysta | Participants with active, autoantibody-positive SLE who did not receive Benlysta but were receiving only SoC therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated SoC therapy within 2 months prior to enrollment) or current users (receiving SoC therapy for >=2 months at enrollment) of SoC therapy. |
|
|
| OG001 | Non-Benlysta | Participants with active, autoantibody-positive SLE who did not receive Benlysta but were receiving only SoC therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated SoC therapy within 2 months prior to enrollment) or current users (receiving SoC therapy for >=2 months at enrollment) of SoC therapy. |
|
|
| OG001 | Non-Benlysta | Participants with active, autoantibody-positive SLE who did not receive Benlysta but were receiving only SoC therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated SoC therapy within 2 months prior to enrollment) or current users (receiving SoC therapy for >=2 months at enrollment) of SoC therapy. |
|
|
| OG001 | Non-Benlysta | Participants with active, autoantibody-positive SLE who did not receive Benlysta but were receiving only SoC therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated SoC therapy within 2 months prior to enrollment) or current users (receiving SoC therapy for >=2 months at enrollment) of SoC therapy. |
|
|
| OG001 | Non-Benlysta | Participants with active, autoantibody-positive SLE who did not receive Benlysta but were receiving only SoC therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated SoC therapy within 2 months prior to enrollment) or current users (receiving SoC therapy for >=2 months at enrollment) of SoC therapy. |
|
|