Trial Outcomes & Findings for Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry (NCT NCT01729455)

Last Updated: 2026-03-20

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

3138 participants

Primary outcome timeframe

Up to 63 Months

Results posted on

2026-03-20

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	2030	937
Overall Study Evaluable Population	1924	881
Overall Study Participants With Missing End-of-Study (EOS) Forms	10	3
Overall Study COMPLETED	1023	485
Overall Study NOT COMPLETED	1007	452

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	8	0
Overall Study Death	48	29
Overall Study Lost to Follow-up	531	233
Overall Study Physician Decision	175	79
Overall Study Withdrawal by Subject	166	54
Overall Study Site Closed/Terminated	79	57

Baseline Characteristics

Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Benlysta n=2030 Participants 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 n=937 Participants 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.	Total n=2967 Participants Total of all reporting groups
Age, Continuous	44.4 YEARS STANDARD_DEVIATION 12.93 • n=154 Participants	44.1 YEARS STANDARD_DEVIATION 14.78 • n=151 Participants	44.3 YEARS STANDARD_DEVIATION 13.54 • n=305 Participants
Sex: Female, Male Female	1899 Participants n=154 Participants	841 Participants n=151 Participants	2740 Participants n=305 Participants
Sex: Female, Male Male	131 Participants n=154 Participants	96 Participants n=151 Participants	227 Participants n=305 Participants
Race/Ethnicity, Customized White	1543 Participants n=154 Participants	645 Participants n=151 Participants	2188 Participants n=305 Participants
Race/Ethnicity, Customized Asian	63 Participants n=154 Participants	64 Participants n=151 Participants	127 Participants n=305 Participants
Race/Ethnicity, Customized Black-African American or African Heritage	342 Participants n=154 Participants	190 Participants n=151 Participants	532 Participants n=305 Participants
Race/Ethnicity, Customized Alaska Native or American Indian from North/Central/South America	42 Participants n=154 Participants	21 Participants n=151 Participants	63 Participants n=305 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	5 Participants n=154 Participants	2 Participants n=151 Participants	7 Participants n=305 Participants
Race/Ethnicity, Customized Multiracial	28 Participants n=154 Participants	11 Participants n=151 Participants	39 Participants n=305 Participants
Race/Ethnicity, Customized Unknown	7 Participants n=154 Participants	4 Participants n=151 Participants	11 Participants n=305 Participants

PRIMARY outcome

Timeframe: Up to 63 Months

Population: Evaluable Population included participants in the Eligible Population with a collection of enrollment data and at least one post-baseline assessment.

Outcome measures

Outcome measures
Measure	Benlysta n=1924 Participants 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 n=881 Participants 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.
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy Mortality	48 Participants	29 Participants
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy Malignancies (excluding NMSC)	44 Participants	24 Participants
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy Serious infections	167 Participants	65 Participants
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy Opportunistic infections	38 Participants	21 Participants
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy Other infections of special interest	44 Participants	19 Participants
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy NMSC	10 Participants	4 Participants
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy Serious psychiatric events	26 Participants	5 Participants

PRIMARY outcome

Timeframe: Up to 12 Months

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Benlysta n=1924 Participants 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 n=881 Participants 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.
Incidence Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy Mortality	0.50 Events per 100 participant-years Interval 0.23 to 0.95	0.88 Events per 100 participant-years Interval 0.38 to 1.73
Incidence Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy Malignancies	0.55 Events per 100 participant-years Interval 0.27 to 1.02	0.66 Events per 100 participant-years Interval 0.24 to 1.44
Incidence Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy Serious infections	2.86 Events per 100 participant-years Interval 2.13 to 3.76	2.33 Events per 100 participant-years Interval 1.44 to 3.56
Incidence Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy Opportunistic infections	0.56 Events per 100 participant-years Interval 0.27 to 1.02	0.66 Events per 100 participant-years Interval 0.24 to 1.44
Incidence Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy Other infections of special interest	0.95 Events per 100 participant-years Interval 0.55 to 1.51	0.88 Events per 100 participant-years Interval 0.38 to 1.74
Incidence Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy NMSC	0.17 Events per 100 participant-years Interval 0.03 to 0.49	NA Events per 100 participant-years As no NMSC events were observed up to 12 months, the incidence rate could not be estimated.
Incidence Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy Serious psychiatric events	0.44 Events per 100 participant-years Interval 0.19 to 0.87	0.11 Events per 100 participant-years Interval 0.0 to 0.61

PRIMARY outcome

Timeframe: Up to 24 Months

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.

Outcome measures

Outcome measures
Measure	Benlysta n=1924 Participants 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 n=881 Participants 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.
Incidence Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy Mortality	0.68 Events per 100 participant-years Interval 0.43 to 1.04	0.84 Events per 100 participant-years Interval 0.48 to 1.37
Incidence Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy Malignancies	0.53 Events per 100 participant-years Interval 0.31 to 0.85	0.90 Events per 100 participant-years Interval 0.53 to 1.44
Incidence Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy Serious infections	2.63 Events per 100 participant-years Interval 2.09 to 3.26	2.52 Events per 100 participant-years Interval 1.85 to 3.35
Incidence Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy Opportunistic infections	0.56 Events per 100 participant-years Interval 0.33 to 0.89	0.53 Events per 100 participant-years Interval 0.25 to 0.97
Incidence Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy Other infections of special interest	0.78 Events per 100 participant-years Interval 0.51 to 1.15	0.64 Events per 100 participant-years Interval 0.33 to 1.11
Incidence Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy NMSC	0.19 Events per 100 participant-years Interval 0.07 to 0.41	0.05 Events per 100 participant-years Interval 0.0 to 0.29
Incidence Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy Serious psychiatric events	0.37 Events per 100 participant-years Interval 0.19 to 0.65	0.32 Events per 100 participant-years Interval 0.12 to 0.69

PRIMARY outcome

Timeframe: Up to 36 Months

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.

Outcome measures

Outcome measures
Measure	Benlysta n=1924 Participants 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 n=881 Participants 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.
Incidence Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy Mortality	0.66 Events per 100 participant-years Interval 0.44 to 0.94	0.88 Events per 100 participant-years Interval 0.57 to 1.3
Incidence Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy Malignancies	0.48 Events per 100 participant-years Interval 0.3 to 0.73	0.71 Events per 100 participant-years Interval 0.43 to 1.09
Incidence Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy Serious infections	2.30 Events per 100 participant-years Interval 1.87 to 2.8	2.59 Events per 100 participant-years Interval 2.03 to 3.27
Incidence Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy Opportunistic infections	0.52 Events per 100 participant-years Interval 0.33 to 0.79	0.74 Events per 100 participant-years Interval 0.46 to 1.14
Incidence Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy Other infections of special interest	0.69 Events per 100 participant-years Interval 0.46 to 0.98	0.67 Events per 100 participant-years Interval 0.4 to 1.05
Incidence Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy NMSC	0.16 Events per 100 participant-years Interval 0.06 to 0.33	0.07 Events per 100 participant-years Interval 0.01 to 0.25
Incidence Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy Serious psychiatric events	0.39 Events per 100 participant-years Interval 0.23 to 0.62	0.28 Events per 100 participant-years Interval 0.12 to 0.56

PRIMARY outcome

Timeframe: Up to 48 Months

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.

Outcome measures

Outcome measures
Measure	Benlysta n=1924 Participants 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 n=881 Participants 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.
Incidence Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy Mortality	0.62 Events per 100 participant-years Interval 0.43 to 0.87	0.94 Events per 100 participant-years Interval 0.65 to 1.3
Incidence Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy Malignancies	0.50 Events per 100 participant-years Interval 0.33 to 0.72	0.68 Events per 100 participant-years Interval 0.44 to 1.0
Incidence Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy Serious infections	2.30 Events per 100 participant-years Interval 1.91 to 2.75	2.38 Events per 100 participant-years Interval 1.91 to 2.94
Incidence Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy Opportunistic infections	0.53 Events per 100 participant-years Interval 0.36 to 0.77	0.79 Events per 100 participant-years Interval 0.53 to 1.13
Incidence Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy Other infections of special interest	0.63 Events per 100 participant-years Interval 0.43 to 0.88	0.65 Events per 100 participant-years Interval 0.42 to 0.97
Incidence Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy NMSC	0.15 Events per 100 participant-years Interval 0.06 to 0.29	0.08 Events per 100 participant-years Interval 0.02 to 0.24
Incidence Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy Serious psychiatric events	0.33 Events per 100 participant-years Interval 0.2 to 0.52	0.27 Events per 100 participant-years Interval 0.13 to 0.5

PRIMARY outcome

Timeframe: Up to 63 Months

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.

Outcome measures

Outcome measures
Measure	Benlysta n=1924 Participants 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 n=881 Participants 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.
Incidence Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy Mortality	0.58 Events per 100 participant-years Interval 0.41 to 0.8	0.89 Events per 100 participant-years Interval 0.63 to 1.21
Incidence Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy Malignancies	0.60 Events per 100 participant-years Interval 0.42 to 0.82	0.67 Events per 100 participant-years Interval 0.45 to 0.96
Incidence Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy Serious infections	2.22 Events per 100 participant-years Interval 1.87 to 2.63	2.45 Events per 100 participant-years Interval 2.0 to 2.96
Incidence Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy Opportunistic infections	0.46 Events per 100 participant-years Interval 0.31 to 0.66	0.72 Events per 100 participant-years Interval 0.49 to 1.02
Incidence Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy Other infections of special interest	0.57 Events per 100 participant-years Interval 0.4 to 0.79	0.63 Events per 100 participant-years Interval 0.42 to 0.91
Incidence Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy NMSC	0.13 Events per 100 participant-years Interval 0.05 to 0.25	0.13 Events per 100 participant-years Interval 0.05 to 0.29
Incidence Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy Serious psychiatric events	0.31 Events per 100 participant-years Interval 0.19 to 0.48	0.27 Events per 100 participant-years Interval 0.14 to 0.47

PRIMARY outcome

Timeframe: Up to 12 Months

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.

Outcome measures

Outcome measures
Measure	Benlysta n=1924 Participants 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 n=881 Participants 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.
Event Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy Malignancies	0.55 Events per 100 participant-years Interval 0.27 to 1.02	0.66 Events per 100 participant-years Interval 0.24 to 1.44
Event Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy Serious infections	3.21 Events per 100 participant-years Interval 2.44 to 4.15	2.64 Events per 100 participant-years Interval 1.69 to 3.92
Event Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy Opportunistic infections	0.55 Events per 100 participant-years Interval 0.27 to 1.02	0.88 Events per 100 participant-years Interval 0.38 to 1.73
Event Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy Other infections of special interest	1.05 Events per 100 participant-years Interval 0.63 to 1.64	0.88 Events per 100 participant-years Interval 0.38 to 1.73
Event Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy NMSC	0.22 Events per 100 participant-years Interval 0.06 to 0.57	NA Events per 100 participant-years As no NMSC events were observed up to 12 months, the event rate could not be estimated.
Event Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy Serious psychiatric events	0.44 Events per 100 participant-years Interval 0.19 to 0.87	0.11 Events per 100 participant-years Interval 0.0 to 0.61

PRIMARY outcome

Timeframe: Up to 24 Months

Outcome measures

Outcome measures
Measure	Benlysta n=1924 Participants 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 n=881 Participants 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.
Event Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy Malignancies	0.53 Events per 100 participant-years Interval 0.31 to 0.85	0.90 Events per 100 participant-years Interval 0.52 to 1.43
Event Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy Serious infections	3.01 Events per 100 participant-years Interval 2.44 to 3.68	2.90 Events per 100 participant-years Interval 2.18 to 3.77
Event Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy Opportunistic infections	0.56 Events per 100 participant-years Interval 0.33 to 0.88	0.63 Events per 100 participant-years Interval 0.33 to 1.1
Event Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy Other infections of special interest	0.84 Events per 100 participant-years Interval 0.55 to 1.22	0.63 Events per 100 participant-years Interval 0.33 to 1.1
Event Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy NMSC	0.22 Events per 100 participant-years Interval 0.09 to 0.45	0.05 Events per 100 participant-years Interval 0.0 to 0.29
Event Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy Serious psychiatric events	0.37 Events per 100 participant-years Interval 0.19 to 0.65	0.37 Events per 100 participant-years Interval 0.15 to 0.76

PRIMARY outcome

Timeframe: Up to 36 Months

Outcome measures

Outcome measures
Measure	Benlysta n=1924 Participants 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 n=881 Participants 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.
Event Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy Malignancies	0.48 Events per 100 participant-years Interval 0.29 to 0.73	0.74 Events per 100 participant-years Interval 0.46 to 1.13
Event Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy Serious infections	2.81 Events per 100 participant-years Interval 2.34 to 3.35	3.23 Events per 100 participant-years Interval 2.6 to 3.96
Event Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy Opportunistic infections	0.54 Events per 100 participant-years Interval 0.35 to 0.81	0.81 Events per 100 participant-years Interval 0.51 to 1.21
Event Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy Other infections of special interest	0.72 Events per 100 participant-years Interval 0.5 to 1.02	0.67 Events per 100 participant-years Interval 0.4 to 1.04
Event Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy NMSC	0.20 Events per 100 participant-years Interval 0.09 to 0.39	0.07 Events per 100 participant-years Interval 0.01 to 0.25
Event Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy Serious psychiatric events	0.43 Events per 100 participant-years Interval 0.26 to 0.67	0.35 Events per 100 participant-years Interval 0.17 to 0.65

PRIMARY outcome

Timeframe: Up to 48 Months

Outcome measures

Outcome measures
Measure	Benlysta n=1924 Participants 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 n=881 Participants 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.
Event Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy Malignancies	0.51 Events per 100 participant-years Interval 0.34 to 0.74	0.70 Events per 100 participant-years Interval 0.46 to 1.02
Event Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy Serious infections	2.80 Events per 100 participant-years Interval 2.37 to 3.28	3.08 Events per 100 participant-years Interval 2.54 to 3.7
Event Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy Opportunistic infections	0.57 Events per 100 participant-years Interval 0.38 to 0.8	0.86 Events per 100 participant-years Interval 0.59 to 1.21
Event Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy Other infections of special interest	0.66 Events per 100 participant-years Interval 0.46 to 0.91	0.67 Events per 100 participant-years Interval 0.43 to 0.99
Event Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy NMSC	0.18 Events per 100 participant-years Interval 0.09 to 0.34	0.08 Events per 100 participant-years Interval 0.02 to 0.23
Event Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy Serious psychiatric events	0.38 Events per 100 participant-years Interval 0.24 to 0.59	0.38 Events per 100 participant-years Interval 0.21 to 0.63

PRIMARY outcome

Timeframe: Up to 63 Months

Outcome measures

Outcome measures
Measure	Benlysta n=1924 Participants 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 n=881 Participants 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.
Event Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy Malignancies	0.61 Events per 100 participant-years Interval 0.43 to 0.83	0.69 Events per 100 participant-years Interval 0.47 to 0.98
Event Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy Serious infections	2.70 Events per 100 participant-years Interval 2.31 to 3.13	3.44 Events per 100 participant-years Interval 2.92 to 4.02
Event Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy Opportunistic infections	0.50 Events per 100 participant-years Interval 0.34 to 0.71	0.87 Events per 100 participant-years Interval 0.62 to 1.18
Event Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy Other infections of special interest	0.59 Events per 100 participant-years Interval 0.42 to 0.81	0.64 Events per 100 participant-years Interval 0.43 to 0.92
Event Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy NMSC	0.17 Events per 100 participant-years Interval 0.09 to 0.31	0.13 Events per 100 participant-years Interval 0.05 to 0.29
Event Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy Serious psychiatric events	0.36 Events per 100 participant-years Interval 0.23 to 0.54	0.35 Events per 100 participant-years Interval 0.2 to 0.58

Adverse Events

Benlysta

Serious events: 248 serious events

Other events: 81 other events

Deaths: 48 deaths

Non-Benlysta

Serious events: 108 serious events

Other events: 32 other events

Deaths: 29 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Benlysta n=1924 participants at risk 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 n=881 participants at risk 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.
Infections and infestations Latent tuberculosis	0.05% 1/1924 • 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.	0.11% 1/881 • 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.
Infections and infestations Listeriosis	0.05% 1/1924 • 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.	0.00% 0/881 • 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.
Infections and infestations Mycobacterium kansasii infection	0.05% 1/1924 • 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.	0.00% 0/881 • 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.
Infections and infestations Oesophageal candidiasis	0.10% 2/1924 • 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.	0.11% 1/881 • 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.
Infections and infestations Ophthalmic herpes zoster	0.05% 1/1924 • 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.	0.00% 0/881 • 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.
Hepatobiliary disorders Hepatic lesion	0.05% 1/1924 • 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.	0.00% 0/881 • 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.
Infections and infestations Cytomegalovirus colitis	0.05% 1/1924 • 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.	0.00% 0/881 • 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.
Infections and infestations Cytomegalovirus viraemia	0.10% 2/1924 • 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.	0.00% 0/881 • 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.
Infections and infestations Gastroenteritis Escherichia coli	0.00% 0/1924 • 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.	0.11% 1/881 • 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.
Infections and infestations Herpes zoster	2.2% 42/1924 • 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.	2.6% 23/881 • 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.
Infections and infestations Herpes zoster cutaneous disseminated	0.10% 2/1924 • 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.	0.11% 1/881 • 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.
Infections and infestations Herpes zoster disseminated	0.10% 2/1924 • 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.	0.11% 1/881 • 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.
Infections and infestations Varicella zoster virus infection	0.05% 1/1924 • 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.	0.00% 0/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Atypical fibroxanthoma	0.05% 1/1924 • 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.	0.00% 0/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.26% 5/1924 • 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.	0.11% 1/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.16% 3/1924 • 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.	0.00% 0/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.05% 1/1924 • 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.	0.00% 0/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.05% 1/1924 • 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.	0.00% 0/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extranodal marginal zone B-cell lymphoma (MALT type)	0.00% 0/1924 • 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.	0.11% 1/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.05% 1/1924 • 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.	0.00% 0/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.10% 2/1924 • 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.	0.00% 0/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.05% 1/1924 • 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.	0.00% 0/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.05% 1/1924 • 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.	0.00% 0/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma stage I	0.05% 1/1924 • 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.	0.00% 0/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.05% 1/1924 • 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.	0.00% 0/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.10% 2/1924 • 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.	0.00% 0/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.05% 1/1924 • 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.	0.00% 0/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.05% 1/1924 • 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.	0.00% 0/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.16% 3/1924 • 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.	0.23% 2/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/1924 • 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.	0.11% 1/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.05% 1/1924 • 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.	0.00% 0/881 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tubular breast carcinoma	0.05% 1/1924 • 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.	0.00% 0/881 • 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.