Systemic Lupus Erythematosus
Conditions
Keywords
belimumab, Chinese, intravenous, subcutaneous, auto-injector
Brief summary
This is an open-label, randomized, parallel group, single dose study in healthy Chinese subjects. The purpose of this study is to characterize the pharmacokinetic profile and safety profile of 200 mg single dose of belimumab, administered either intravenously or subcutaneously via auto-injector. Each subject will be randomized in a 1:2 ratio to receive a single dose of either intravenous (IV) or subcutaneous (SC) administration of belimumab 200 mg. The total study duration will be approximately 13 weeks.
Interventions
DRUGBelimumab for IV
Belimumab will be available as white to off-white lyophilized cake at a unit dose strength of 400 mg to be reconstituted and diluted in normal saline to obtain 200 mg per dose.
DRUGBelimumab for SC
Belimumab will be available as clear to opalescent, colorless to pale yellow sterile solution at unit dose strength of 200 mg/milliliter (mg/mL) for SC injection in a single-use, prefilled syringe contained within an auto-injector device.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be randomized in a 1:2 ratio to receive one treatment of either IV or SC administration of belimumab 200 mg.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol. * Chinese healthy male or female between 18 and 45 years of age inclusive, at the time of signing the informed consent. * Healthy as defined as being free from clinically significant illness or disease as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital sign, laboratory tests and ECG. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
Exclusion criteria
, outside the reference range for the population being studied, may be included only if the investigator (in consultation with the GlaxoSmithKline (GSK) medical monitor if necessary) agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Non-smoker or ex-smoker having ceased smoking for at least 6 months. * Body weight \>=45.0 kilograms (kg) for females, \>=50.0 kg for males, and body mass index (BMI) within the range 19.0\<= to \<=26.0 kilograms per meter square (kg/m\^2). * Both male and female subjects are eligible to participate. * A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: i) Not a woman of childbearing potential (WOCBP) OR ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of belimumab.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentration of Belimumab Following Intravenous Administration | Pre-dose (prior to start of belimumab IV infusion), 30 minutes (after the start of infusion), 0 hour (end of infusion); at 1, 6, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344 and 1680 hours after end of infusion | Blood samples were collected at indicated time points for measurement of serum concentrations of belimumab following intravenous administration. Pharmacokinetic Population comprised of all safety participants (all randomized participants who received at least one dose of study treatment) for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. |
| Serum Concentration of Belimumab Following Subcutaneous Administration | Pre-dose and at 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 240 hours, 336 hours, 504 hours, 672 hours, 1008 hours, 1344 hours and 1680 hours post-dose | Blood samples were collected at indicated time points for measurement of serum concentrations of belimumab following subcutaneous administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormal Clinical Chemistry Parameters | Up to Day 71 | Blood samples were collected for the assessment of clinical chemistry parameters. The normal ranges were: alanine aminotransferase(7-40 international units per liter\[IU/L\]), albumin(40-55 grams per liter\[g/L\]), alkaline phosphatase(35-100 IU/L), amylase(25-125 units per liter), aspartate aminotransferase(13-35 IU/L), bilirubin(Bil.)(3.4-20.5 micromoles per liter \[µmol/L\]), calcium(2.1-2.55 millimoles per liter\[mmol/L\]), chloride(99-110 mmol/L), cholesterol(Chol.)(0-5.17 mmol/L), creatine kinase(29-168 IU/L), creatinine(41-73 µmol/L), direct Bil.(0-8.6 µmol/L), gamma glutamyl transferase(7-45 IU/L), glucose(3.9-6.1 mmol/L), high density Chol.(1.04-1.55 mmol/L), low density Chol.(2.59-4.11 mmol/L), lactate dehydrogenase(120-250 IU/L), phosphate(0.74-1.52 mmol/L), potassium(3.5-5.3 mmol/L), protein(65-85 g/L), sodium(137-147 mmol/L), triglycerides(0-1.69 mmol/L), urate(150-350 µmol/L), urea(2.6-7.5 mmol/L). Number of participants with abnormal clinical chemistry parameters are presented. |
| Number of Participants With Abnormal Hematology Parameters | Up to Day 71 | Blood samples were collected for the assessment of hematology parameters. The normal ranges for the parameters were: basophil count (\[0.00-0.06\]\*10\^9 cells per liter \[cells/L\]), eosinophil count (\[0.02-0.52\]\*10\^9 cells/L), erythrocyte count (\[3.8-5.1\]\*10\^12 cells/L), hematocrit (0.35-0.45 proportion of red blood cells in blood), hemoglobin (115-150 g/L), leukocyte count (\[3.5-9.5\]\*10\^9 cells/L), lymphocyte count (\[1.1-3.2\]\*10\^9 cells/L), monocyte count (\[0.1-0.6\]\*10\^9 cells/L), neutrophil count (\[1.8-6.3\]\*10\^9 cells/L), platelet count (\[125-350\]\*10\^9 cells/L). Number of participants with abnormal hematology parameters are presented. |
| Number of Participants With Abnormal Vital Signs | Up to Day 71 | Vital signs were measured in a semi-supine position after five minutes of rest and included tympanic temperature, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate. The normal ranges were: temperature (35.0-38.0 degrees celsius), SBP (85-160 millimeters of mercury \[mmHg\]), DBP (45-100 mmHg), heart rate (60-90 beats per minute). Number of participants with abnormality in any vital signs are presented. Safety Population comprised of all randomized participants who received at least one dose of study treatment. |
| Number of Participants With Injection Site Reaction | Up to Day 71 | Local tolerability as measured by injection site reaction example: induration, erythema, edema, rash, pruritis or pain. Number of participants with any injection site reaction are presented. |
| Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events | Up to Day 71 | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician. Number of participants who had SAEs and non-SAEs are presented. |
| Number of Participants With Abnormal Urinalysis Parameters | Up to Day 71 | Urine samples were analyzed for glucose, ketones, occult blood and protein by dipstick method. The dipstick test results are read as Negative, Trace, 1+, 2+, 3+, 4+ indicating proportional concentrations in the urine sample. Normal range for dipstick test results are 'negative' results. Urine potential of hydrogen (pH) and specific gravity were also analyzed. pH is measured on a numeric scale of 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Urine specific gravity is a measure of the concentration of solutes in the urine and indicated as ratio of urine density to water density. The normal ranges for pH: 4.8 to 7.4; and for specific gravity: 1.003 to 1.03. Number of participants with abnormal results in any urinalysis parameters are presented. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Up to Day 71 | Twelve-lead ECGs were recorded with the participants in a semi-supine position, after 5 minutes of rest using an ECG machine. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with clinically significant and not clinically significant abnormal ECG findings have been presented. |
Countries
China
Participant flow
Recruitment details
This was an open-label, randomized, parallel group, single dose study to evaluate safety and pharmacokinetics (PK) of belimumab, administered either intravenously (IV) or subcutaneously (SC) via an auto-injector in healthy Chinese participants.
Pre-assignment details
A total of 171 participants were screened and 36 participants were enrolled and randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| Belimumab 200 mg IV Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour. | 12 |
| Belimumab 200 mg SC Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device. | 24 |
| Total | 36 |
Baseline characteristics
| Characteristic | Belimumab 200 mg IV | Belimumab 200 mg SC | Total |
|---|---|---|---|
| Age, Continuous | 27.9 Years STANDARD_DEVIATION 3.99 | 29.1 Years STANDARD_DEVIATION 6.44 | 28.7 Years STANDARD_DEVIATION 5.71 |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 12 Participants | 24 Participants | 36 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 9 Participants | 20 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 24 |
| other Total, other adverse events | 11 / 12 | 24 / 24 |
| serious Total, serious adverse events | 0 / 12 | 0 / 24 |
Outcome results
Primary
Serum Concentration of Belimumab Following Intravenous Administration
Blood samples were collected at indicated time points for measurement of serum concentrations of belimumab following intravenous administration. Pharmacokinetic Population comprised of all safety participants (all randomized participants who received at least one dose of study treatment) for whom at least one evaluable pharmacokinetic sample was obtained and analyzed.
Time frame: Pre-dose (prior to start of belimumab IV infusion), 30 minutes (after the start of infusion), 0 hour (end of infusion); at 1, 6, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344 and 1680 hours after end of infusion
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Intravenous Administration | Pre-dose (prior to start of belimumab IV infusion) | 0.0 Nanograms per milliliter | Standard Deviation 0 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Intravenous Administration | 30 minutes (after the start of infusion) | 26567.4 Nanograms per milliliter | Standard Deviation 3602.68 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Intravenous Administration | 0 hour (end of infusion) | 63403.2 Nanograms per milliliter | Standard Deviation 6104.64 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Intravenous Administration | 1hour after end of infusion | 64474.6 Nanograms per milliliter | Standard Deviation 9167.16 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Intravenous Administration | 6 hours after end of infusion | 57450.1 Nanograms per milliliter | Standard Deviation 7804.49 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Intravenous Administration | 24 hours after end of infusion | 50284.8 Nanograms per milliliter | Standard Deviation 4898.92 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Intravenous Administration | 48 hours after end of infusion | 40738.2 Nanograms per milliliter | Standard Deviation 6858.36 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Intravenous Administration | 72 hours after end of infusion | 32845.9 Nanograms per milliliter | Standard Deviation 9835.93 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Intravenous Administration | 96 hours after end of infusion | 30995.0 Nanograms per milliliter | Standard Deviation 6472.1 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Intravenous Administration | 168 hours after end of infusion | 23850.3 Nanograms per milliliter | Standard Deviation 3898.42 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Intravenous Administration | 336 hours after end of infusion | 15930.7 Nanograms per milliliter | Standard Deviation 3859.5 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Intravenous Administration | 504 hours after end of infusion | 11291.5 Nanograms per milliliter | Standard Deviation 3860.41 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Intravenous Administration | 672 hours after end of infusion | 10115.7 Nanograms per milliliter | Standard Deviation 2289.97 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Intravenous Administration | 1008 hours after end of infusion | 5838.3 Nanograms per milliliter | Standard Deviation 1868.93 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Intravenous Administration | 1344 hours after end of infusion | 3146.7 Nanograms per milliliter | Standard Deviation 1275.16 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Intravenous Administration | 1680 hours after end of infusion | 1916.6 Nanograms per milliliter | Standard Deviation 936.49 |
Primary
Serum Concentration of Belimumab Following Subcutaneous Administration
Blood samples were collected at indicated time points for measurement of serum concentrations of belimumab following subcutaneous administration.
Time frame: Pre-dose and at 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 240 hours, 336 hours, 504 hours, 672 hours, 1008 hours, 1344 hours and 1680 hours post-dose
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Subcutaneous Administration | Pre-dose | 0.0 Nanograms per milliliter | Standard Deviation 0 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Subcutaneous Administration | 6 hours post-dose | 963.8 Nanograms per milliliter | Standard Deviation 875.47 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Subcutaneous Administration | 24 hours post-dose | 6255.4 Nanograms per milliliter | Standard Deviation 4255.21 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Subcutaneous Administration | 48 hours post-dose | 11838.9 Nanograms per milliliter | Standard Deviation 5838.53 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Subcutaneous Administration | 72 hours post-dose | 14501.9 Nanograms per milliliter | Standard Deviation 6105.54 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Subcutaneous Administration | 96 hours post-dose | 16682.3 Nanograms per milliliter | Standard Deviation 6038.3 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Subcutaneous Administration | 120 hours post-dose | 16131.3 Nanograms per milliliter | Standard Deviation 6055.17 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Subcutaneous Administration | 144 hours post-dose | 16752.1 Nanograms per milliliter | Standard Deviation 5184.15 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Subcutaneous Administration | 168 hours post-dose | 16825.5 Nanograms per milliliter | Standard Deviation 5095.95 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Subcutaneous Administration | 240 hours post-dose | 17262.9 Nanograms per milliliter | Standard Deviation 3702 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Subcutaneous Administration | 336 hours post-dose | 14724.2 Nanograms per milliliter | Standard Deviation 3519.94 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Subcutaneous Administration | 504 hours post-dose | 11235.9 Nanograms per milliliter | Standard Deviation 2928.08 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Subcutaneous Administration | 672 hours post-dose | 7551.1 Nanograms per milliliter | Standard Deviation 2836.06 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Subcutaneous Administration | 1008 hours post-dose | 4720.3 Nanograms per milliliter | Standard Deviation 1827.4 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Subcutaneous Administration | 1344 hours post-dose | 2651.6 Nanograms per milliliter | Standard Deviation 1345.36 |
| Belimumab 200 mg IV | Serum Concentration of Belimumab Following Subcutaneous Administration | 1680 hours post-dose | 1365.7 Nanograms per milliliter | Standard Deviation 931.47 |
Secondary
Number of Participants With Abnormal Clinical Chemistry Parameters
Blood samples were collected for the assessment of clinical chemistry parameters. The normal ranges were: alanine aminotransferase(7-40 international units per liter\[IU/L\]), albumin(40-55 grams per liter\[g/L\]), alkaline phosphatase(35-100 IU/L), amylase(25-125 units per liter), aspartate aminotransferase(13-35 IU/L), bilirubin(Bil.)(3.4-20.5 micromoles per liter \[µmol/L\]), calcium(2.1-2.55 millimoles per liter\[mmol/L\]), chloride(99-110 mmol/L), cholesterol(Chol.)(0-5.17 mmol/L), creatine kinase(29-168 IU/L), creatinine(41-73 µmol/L), direct Bil.(0-8.6 µmol/L), gamma glutamyl transferase(7-45 IU/L), glucose(3.9-6.1 mmol/L), high density Chol.(1.04-1.55 mmol/L), low density Chol.(2.59-4.11 mmol/L), lactate dehydrogenase(120-250 IU/L), phosphate(0.74-1.52 mmol/L), potassium(3.5-5.3 mmol/L), protein(65-85 g/L), sodium(137-147 mmol/L), triglycerides(0-1.69 mmol/L), urate(150-350 µmol/L), urea(2.6-7.5 mmol/L). Number of participants with abnormal clinical chemistry parameters are presented.
Time frame: Up to Day 71
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Belimumab 200 mg IV | Number of Participants With Abnormal Clinical Chemistry Parameters | 12 Participants |
| Belimumab 200 mg SC | Number of Participants With Abnormal Clinical Chemistry Parameters | 24 Participants |
Secondary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Twelve-lead ECGs were recorded with the participants in a semi-supine position, after 5 minutes of rest using an ECG machine. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with clinically significant and not clinically significant abnormal ECG findings have been presented.
Time frame: Up to Day 71
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Belimumab 200 mg IV | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal-Not Clinically significant | 3 Participants |
| Belimumab 200 mg IV | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal-Clinically significant | 0 Participants |
| Belimumab 200 mg SC | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal-Not Clinically significant | 7 Participants |
| Belimumab 200 mg SC | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal-Clinically significant | 2 Participants |
Secondary
Number of Participants With Abnormal Hematology Parameters
Blood samples were collected for the assessment of hematology parameters. The normal ranges for the parameters were: basophil count (\[0.00-0.06\]\*10\^9 cells per liter \[cells/L\]), eosinophil count (\[0.02-0.52\]\*10\^9 cells/L), erythrocyte count (\[3.8-5.1\]\*10\^12 cells/L), hematocrit (0.35-0.45 proportion of red blood cells in blood), hemoglobin (115-150 g/L), leukocyte count (\[3.5-9.5\]\*10\^9 cells/L), lymphocyte count (\[1.1-3.2\]\*10\^9 cells/L), monocyte count (\[0.1-0.6\]\*10\^9 cells/L), neutrophil count (\[1.8-6.3\]\*10\^9 cells/L), platelet count (\[125-350\]\*10\^9 cells/L). Number of participants with abnormal hematology parameters are presented.
Time frame: Up to Day 71
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Belimumab 200 mg IV | Number of Participants With Abnormal Hematology Parameters | 10 Participants |
| Belimumab 200 mg SC | Number of Participants With Abnormal Hematology Parameters | 15 Participants |
Secondary
Number of Participants With Abnormal Urinalysis Parameters
Urine samples were analyzed for glucose, ketones, occult blood and protein by dipstick method. The dipstick test results are read as Negative, Trace, 1+, 2+, 3+, 4+ indicating proportional concentrations in the urine sample. Normal range for dipstick test results are 'negative' results. Urine potential of hydrogen (pH) and specific gravity were also analyzed. pH is measured on a numeric scale of 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Urine specific gravity is a measure of the concentration of solutes in the urine and indicated as ratio of urine density to water density. The normal ranges for pH: 4.8 to 7.4; and for specific gravity: 1.003 to 1.03. Number of participants with abnormal results in any urinalysis parameters are presented.
Time frame: Up to Day 71
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Belimumab 200 mg IV | Number of Participants With Abnormal Urinalysis Parameters | 4 Participants |
| Belimumab 200 mg SC | Number of Participants With Abnormal Urinalysis Parameters | 11 Participants |
Secondary
Number of Participants With Abnormal Vital Signs
Vital signs were measured in a semi-supine position after five minutes of rest and included tympanic temperature, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate. The normal ranges were: temperature (35.0-38.0 degrees celsius), SBP (85-160 millimeters of mercury \[mmHg\]), DBP (45-100 mmHg), heart rate (60-90 beats per minute). Number of participants with abnormality in any vital signs are presented. Safety Population comprised of all randomized participants who received at least one dose of study treatment.
Time frame: Up to Day 71
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Belimumab 200 mg IV | Number of Participants With Abnormal Vital Signs | 0 Participants |
| Belimumab 200 mg SC | Number of Participants With Abnormal Vital Signs | 0 Participants |
Secondary
Number of Participants With Injection Site Reaction
Local tolerability as measured by injection site reaction example: induration, erythema, edema, rash, pruritis or pain. Number of participants with any injection site reaction are presented.
Time frame: Up to Day 71
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Belimumab 200 mg IV | Number of Participants With Injection Site Reaction | 0 Participants |
| Belimumab 200 mg SC | Number of Participants With Injection Site Reaction | 19 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician. Number of participants who had SAEs and non-SAEs are presented.
Time frame: Up to Day 71
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Belimumab 200 mg IV | Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events | SAEs | 0 Participants |
| Belimumab 200 mg IV | Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events | Non-SAEs | 11 Participants |
| Belimumab 200 mg SC | Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events | SAEs | 0 Participants |
| Belimumab 200 mg SC | Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events | Non-SAEs | 24 Participants |