Trial Outcomes & Findings for Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE) (NCT NCT04908865)

Last Updated: 2025-07-23

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs included malignancies, post-infusion systemic or hypersensitivity reactions, infections (including serious infections of special interest), and depression, suicide, or self-injury. Infections of special interest included opportunistic infections (OI), herpes zoster (HZ), tuberculosis (TB), and sepsis. Number of participants with AESIs as identified by custom Medical Dictionary for Regulatory Activities (MedDRA) query has been reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

67 participants

Primary outcome timeframe

Up to Week 52

Results posted on

2025-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	Belimumab Participants with active systemic lupus erythematosus (SLE) received belimumab at 10 milligrams per kilogram (mg/kg) body weight by intravenous (IV) infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.
Overall Study STARTED	67
Overall Study Pharmacokinetic (PK) Population	26
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Belimumab Participants with active systemic lupus erythematosus (SLE) received belimumab at 10 milligrams per kilogram (mg/kg) body weight by intravenous (IV) infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.
Overall Study Adverse Event	2
Overall Study Lack of Efficacy	5
Overall Study Lost to Follow-up	1

Baseline Characteristics

Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belimumab n=67 Participants Participants with active SLE received belimumab at 10 mg/kg body weight by IV infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.
Age, Continuous	13.0 YEARS STANDARD_DEVIATION 2.22 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race/Ethnicity, Customized Asian	67 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 52

Population: Intent-to-Treat (ITT) population consisted of all participants who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Belimumab n=67 Participants Participants with active SLE received belimumab at 10 mg/kg body weight by IV infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.
Number of Participants With Adverse Events of Special Interest (AESIs) Through Week 52 All malignancies	0 Participants
Number of Participants With Adverse Events of Special Interest (AESIs) Through Week 52 Post-infusion systemic reactions (PISR)	0 Participants
Number of Participants With Adverse Events of Special Interest (AESIs) Through Week 52 All infections of special interest (OI, HZ, TB, sepsis)	2 Participants
Number of Participants With Adverse Events of Special Interest (AESIs) Through Week 52 Depression (including mood disorders and anxiety)/suicide/self-injury	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0) and Week 52

Population: ITT population consisted of all participants who received at least one dose of study treatment. One participant with Baseline SELENA-SLEDAI score less than 4 was excluded from the analysis.

The SELENA-SLEDAI score is a cumulative and weighted index for assessing SLE disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with a decrease of 4 points or more in the score at Week 52 compared to their Baseline score is presented.

Outcome measures

Outcome measures
Measure	Belimumab n=66 Participants Participants with active SLE received belimumab at 10 mg/kg body weight by IV infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.
Number of Participants With Greater Than Equal to (>=) 4 Points Reduction From Baseline to Week 52 in Safety of Estrogen in Lupus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Score	44 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: ITT population consisted of all participants who received at least one dose of study treatment.

An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a birth defect or congenital anomaly, or other situations as per the medical or scientific judgment of the investigator. Number of participants with AEs and SAEs has been reported.

Outcome measures

Outcome measures
Measure	Belimumab n=67 Participants Participants with active SLE received belimumab at 10 mg/kg body weight by IV infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.
Number of Participants With AEs and Serious Adverse Events (SAEs) Through Week 52 AEs	56 Participants
Number of Participants With AEs and Serious Adverse Events (SAEs) Through Week 52 SAEs	19 Participants

SECONDARY outcome

Timeframe: Baseline (Day 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

Population: ITT population. 1 participant with Baseline SELENA-SLEDAI score below 4 was excluded. All 66 participants served as denominator to calculate percentages at each visit. For all visits except Week 52 (where percentage value was rounded off as no data was missing), missing data from missed visits were handled by multiple imputation. Estimates generated for every imputed dataset were combined by Rubin's rules to obtain percentages. So reported percentages may not yield whole number of participants.

The SELENA-SLEDAI score is a cumulative and weighted index for assessing SLE disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage of participants with a decrease of 4 points or more in the score at each visit compared to their Baseline score is presented.

Outcome measures

Outcome measures
Measure	Belimumab n=66 Participants Participants with active SLE received belimumab at 10 mg/kg body weight by IV infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.
Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each Visit Week 4	39.8 Percentage of Participants
Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each Visit Week 8	51.8 Percentage of Participants
Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each Visit Week 12	68.9 Percentage of Participants
Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each Visit Week 16	69.0 Percentage of Participants
Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each Visit Week 20	65.4 Percentage of Participants
Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each Visit Week 24	68.1 Percentage of Participants
Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each Visit Week 28	65.7 Percentage of Participants
Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each Visit Week 32	67.7 Percentage of Participants
Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each Visit Week 36	69.1 Percentage of Participants
Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each Visit Week 40	75.1 Percentage of Participants
Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each Visit Week 44	74.2 Percentage of Participants
Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each Visit Week 48	71.3 Percentage of Participants
Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each Visit Week 52	66.7 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline (Day 0) and Week 52

Population: ITT population consisted of all participants who received at least one dose of study treatment.

The PGA is used to assess the participant's current disease activity by investigator. It is collected on a 10 centimeter (cm) visual analogue scale. The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Belimumab n=67 Participants Participants with active SLE received belimumab at 10 mg/kg body weight by IV infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.
Change From Baseline to Week 52 in Physician Global Assessment (PGA)	-0.931 Scores on scale Standard Deviation 0.6046

SECONDARY outcome

Timeframe: Baseline (Day 0) and Week 52

Population: ITT population consisted of all participants who received at least one dose of study treatment.

The ParentGA is used to assess the participant's overall well-being at the moment rated on a 21-numbered circle visual analog scale by the parent. The score ranges from 0 (very well) to 10 (very poorly). Higher score indicates worse effect of the illness on the child. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Belimumab n=67 Participants Participants with active SLE received belimumab at 10 mg/kg body weight by IV infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.
Change From Baseline to Week 52 in Parent Global Assessment (ParentGA)	-2.71 Scores on scale Standard Deviation 2.713

SECONDARY outcome

Timeframe: Baseline (Day 0) and Week 52

Population: ITT population consisted of all participants who received at least one dose of study treatment. 'Overall Number of Participants Analyzed' included only those participants who were analyzed (i.e., contributed data reported in table).

The average daily prednisone equivalent dose accounted for all steroids taken IV, intramuscularly (IM), subcutaneously (SC), intradermally, and orally for both SLE and non-SLE reasons. All steroid dosages were converted to a prednisone equivalent in mg at each visit. The daily prednisone equivalent dose for a steroid was calculated as follows: collected dose of the steroid in mg multiplied by (\*) conversion factor \* frequency factor. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. At Baseline, the average daily prednisone equivalent dose was the sum of all prednisone doses over 7 consecutive days up to but not including Day 0, divided by 7. The average daily prednisone dose at Week 52 visit was the sum of all prednisone doses over 7 consecutive days up to and including the Week 52 visit, divided by 7. Average daily prednisone equivalent dose was expressed in milligrams per day.

Outcome measures

Outcome measures
Measure	Belimumab n=59 Participants Participants with active SLE received belimumab at 10 mg/kg body weight by IV infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.
Change From Baseline in Average Daily Prednisone Equivalent Dose at Week 52	-6.020 milligrams per day Standard Deviation 9.2970

SECONDARY outcome

Timeframe: Up to Week 52

Population: ITT population consisted of all participants who received at least one dose of study treatment. 'Overall number of participants analyzed' included those participants who experienced a post-baseline SFI flare over 52 weeks.

The SLE flare index (SFI) is used to categorize SLE flares as mild/moderate or severe. A mild/moderate SFI flare involves: a SELENA-SLEDAI score increase of 3 to 12 points (higher score means greater disease activity); SLE symptom development; prednisone dose increase (but not above 0.5 milligrams per kilogram per day \[mg/kg/day\]); non-steroidal anti-inflammatory drugs (NSAIDs)/hydroxychloroquine addition; or PGA score increase by 1 or more, but not to more than 2.5 (higher score means greater disease activity). A severe SFI flare involves: SELENA-SLEDAI score increase over 12 points; onset or worsening of severe SLE symptoms; prednisone dose increase above 0.5 mg/kg/day; introduction of potent immunosuppressants; hospitalization; or PGA score reaching 2.5 or higher. Time to first SLE flare (mild/moderate or severe) was the number of days from treatment start date until the participant met an event. Time to first flare was defined as event date minus treatment start date plus 1.

Outcome measures

Outcome measures
Measure	Belimumab n=50 Participants Participants with active SLE received belimumab at 10 mg/kg body weight by IV infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.
Time to First Flare Over 52 Weeks	141.0 days Interval 58.0 to 333.0

SECONDARY outcome

Timeframe: Up to Week 52

The SFI is used to categorize SLE flares as mild/moderate or severe. A severe SFI flare involves SELENA-SLEDAI score increase over 12 points (higher score means greater disease activity), onset or worsening of severe SLE symptoms, prednisone dose increase above 0.5 mg/kg/day, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher (higher score means higher disease activity). Time to first severe SLE flare was the number of days from treatment start date until the participant met an event. Time to first severe flare was defined as event date minus treatment start date plus 1.

Outcome measures

Outcome measures
Measure	Belimumab n=18 Participants Participants with active SLE received belimumab at 10 mg/kg body weight by IV infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.
Time to First Severe Flare Over 52 Weeks	NA days Interval 289.0 to 'NA' indicates that the median time and/or interquartile range could not be estimated due to low number of events in the participants.

SECONDARY outcome

Timeframe: Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84

Population: Pharmacokinetic (PK) population consisted of all the participants who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed. 'Overall number of participants analyzed' included only those participants who were analyzed (i.e., contributed data reported in table). 'Number analyzed' included participants evaluable for specified time points.

Blood samples were collected at indicated time points for measurement of plasma concentrations of belimumab.

Outcome measures

Outcome measures
Measure	Belimumab n=26 Participants Participants with active SLE received belimumab at 10 mg/kg body weight by IV infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.
Median Belimumab Concentration Levels at Day 0, 7, and 14 Days Post First Dose, and Pre-infusion and Post-infusion at Day 84 Day 0	197.1173 Micrograms per milliliter Interval 141.9326 to 257.3748
Median Belimumab Concentration Levels at Day 0, 7, and 14 Days Post First Dose, and Pre-infusion and Post-infusion at Day 84 Day 7	71.3616 Micrograms per milliliter Interval 35.9532 to 100.5913
Median Belimumab Concentration Levels at Day 0, 7, and 14 Days Post First Dose, and Pre-infusion and Post-infusion at Day 84 Day 14	37.8585 Micrograms per milliliter Interval 14.5944 to 74.1679
Median Belimumab Concentration Levels at Day 0, 7, and 14 Days Post First Dose, and Pre-infusion and Post-infusion at Day 84 Day 84, pre-infusion	28.2415 Micrograms per milliliter Interval 2.3467 to 89.0718
Median Belimumab Concentration Levels at Day 0, 7, and 14 Days Post First Dose, and Pre-infusion and Post-infusion at Day 84 Day 84, post-infusion	238.5688 Micrograms per milliliter Interval 139.1862 to 357.0316

Serious events: 20 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Belimumab n=67 participants at risk Participants with active SLE received belimumab at 10 mg/kg body weight by IV infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.
Infections and infestations Bronchitis	4.5% 3/67 • Number of events 3 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations COVID-19	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Gastroenteritis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations H1N1 influenza	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Pneumonia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Upper respiratory tract infection	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Urinary tract infection	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Nervous system disorders Headache	3.0% 2/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Nervous system disorders Cerebral infarction	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Rash	6.0% 4/67 • Number of events 4 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Alopecia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	4.5% 3/67 • Number of events 4 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
General disorders Pyrexia	3.0% 2/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	3.0% 2/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	1.5% 1/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Cardiac disorders Myocarditis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Eye disorders Eyelid oedema	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Hepatobiliary disorders Hepatic function abnormal	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Immune system disorders Hypogammaglobulinaemia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Nervous system disorders Neuromyelitis optica spectrum disorder	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Pancreatitis necrotising	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.

Other adverse events

Other adverse events
Measure	Belimumab n=67 participants at risk Participants with active SLE received belimumab at 10 mg/kg body weight by IV infusion over a minimum of 1 hour on Days 0, 14, 28, and then every 28 days through Week 48 in combination with standard therapy.
Infections and infestations Upper respiratory tract infection	46.3% 31/67 • Number of events 63 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations COVID-19	13.4% 9/67 • Number of events 9 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Coronavirus pneumonia	16.4% 11/67 • Number of events 11 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Bronchitis	6.0% 4/67 • Number of events 5 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	13.4% 9/67 • Number of events 13 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Hepatobiliary disorders Hepatic function abnormal	13.4% 9/67 • Number of events 13 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Investigations Lymphocyte count decreased	7.5% 5/67 • Number of events 9 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Investigations White blood cell count decreased	6.0% 4/67 • Number of events 11 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
General disorders Pyrexia	10.4% 7/67 • Number of events 9 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Rash	6.0% 4/67 • Number of events 4 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Renal and urinary disorders Renal failure	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Endocrine disorders Autoimmune thyroiditis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Ear and labyrinth disorders Cerumen impaction	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Gastroenteritis	4.5% 3/67 • Number of events 3 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Conjunctivitis	3.0% 2/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Infection	3.0% 2/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Influenza	3.0% 2/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Oral candidiasis	3.0% 2/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Pneumonia	3.0% 2/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Respiratory tract infection	3.0% 2/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Tinea versicolour	3.0% 2/67 • Number of events 3 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Urinary tract infection	3.0% 2/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Abscess soft tissue	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Adenovirus infection	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Gingivitis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Helicobacter infection	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Herpangina	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Mumps	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Nasopharyngitis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Oral herpes	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Otitis media	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Pharyngitis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Rhinovirus infection	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Sepsis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Sinusitis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Tinea pedis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Varicella	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Viral infection	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Viral upper respiratory tract infection	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Infections and infestations Gastroenteritis viral	1.5% 1/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	1.5% 1/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Gastritis	4.5% 3/67 • Number of events 3 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Functional gastrointestinal disorder	3.0% 2/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Mouth ulceration	3.0% 2/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal discomfort	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal pain	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Anal fissure	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Cheilitis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Constipation	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Diarrhoea	1.5% 1/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Dyspepsia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Faeces discoloured	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Gastrointestinal disorder	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Pancreatic pseudocyst	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Pancreatitis acute	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
General disorders Chest pain	3.0% 2/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
General disorders Face oedema	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
General disorders Fatigue	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
General disorders Peripheral swelling	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Hepatobiliary disorders Cholestasis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Hepatobiliary disorders Hepatic steatosis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Hepatobiliary disorders Hepatomegaly	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Hepatobiliary disorders Hepatic lesion	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Investigations Intraocular pressure increased	4.5% 3/67 • Number of events 3 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Investigations Neutrophil count increased	3.0% 2/67 • Number of events 3 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Investigations Blood bilirubin increased	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Investigations Blood immunoglobulin M decreased	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Investigations Blood phosphorus decreased	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Investigations Bone density decreased	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Investigations CD19 lymphocytes decreased	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Investigations Neutrophil count decreased	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Investigations Reticulocyte count increased	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Investigations White blood cell count increased	1.5% 1/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Alopecia	3.0% 2/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis allergic	3.0% 2/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Acne	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Cutaneous vasculitis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Urticaria	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	4.5% 3/67 • Number of events 4 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypercholesterolaemia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hyperlipidaemia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypertriglyceridaemia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hyperuricaemia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypocalcaemia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	1.5% 1/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypophosphataemia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypoproteinaemia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Anaemia	4.5% 3/67 • Number of events 3 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Iron deficiency anaemia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Leukocytosis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Neutropenia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Polycythaemia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Eye disorders Xerophthalmia	3.0% 2/67 • Number of events 2 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Eye disorders Conjunctivitis allergic	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Eye disorders Eyelid oedema	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Eye disorders Ocular hypertension	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Eye disorders Retinal haemorrhage	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Animal bite	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Arthropod bite	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Contusion	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Hand fracture	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Ligament sprain	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Cardiac disorders Arrhythmia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Cardiac disorders Myocardial injury	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Cardiac disorders Pericardial effusion	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Cardiac disorders Sinus bradycardia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Cardiac disorders Tachycardia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Arthritis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Osteonecrosis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Vascular disorders Endocrine hypertension	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Vascular disorders Hypertension	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Vascular disorders Venous thrombosis	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Immune system disorders Drug hypersensitivity	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Immune system disorders Hypogammaglobulinaemia	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Nervous system disorders Headache	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.
Nervous system disorders Seizure	1.5% 1/67 • Number of events 1 • All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64 All-cause mortality, SAEs, and non-SAEs were reported for ITT population that comprised of all participants who received at least 1 dose of study treatment.

Additional Information

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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.
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