Trial Outcomes & Findings for Study of Belimumab Administered Subcutaneously to Healthy Subjects (NCT NCT01583530)
NCT ID: NCT01583530
Last Updated: 2013-08-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
118 participants
Primary outcome timeframe
Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
Results posted on
2013-08-07
Participant Flow
Participant milestones
| Measure |
Belimumab IV 240 mg
Belimumab IV 240 mg administered on Day 0
|
Belimumab SC 2 x 120 mg
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
|
Belimumab SC 1 x 240 mg
Belimumab SC 240 mg x 1 injection on Day 0
|
Belimumab SC 1 x 200 mg
Belimumab SC 200 mg x 1 injection on Day 0
|
Belimumab SC 2 x 120 mg Weekly
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
|
Belimumab SC 1 x 200 mg Weekly
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
20
|
19
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
17
|
20
|
18
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
0
|
1
|
5
|
3
|
Reasons for withdrawal
| Measure |
Belimumab IV 240 mg
Belimumab IV 240 mg administered on Day 0
|
Belimumab SC 2 x 120 mg
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
|
Belimumab SC 1 x 240 mg
Belimumab SC 240 mg x 1 injection on Day 0
|
Belimumab SC 1 x 200 mg
Belimumab SC 200 mg x 1 injection on Day 0
|
Belimumab SC 2 x 120 mg Weekly
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
|
Belimumab SC 1 x 200 mg Weekly
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
0
|
1
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Overall Study
Lack of compliance
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of Belimumab Administered Subcutaneously to Healthy Subjects
Baseline characteristics by cohort
| Measure |
Belimumab IV 240 mg
n=19 Participants
Belimumab IV 240 mg administered on Day 0
|
Belimumab SC 2 x 120 mg
n=20 Participants
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
|
Belimumab SC 1 x 240 mg
n=20 Participants
Belimumab SC 240 mg x 1 injection on Day 0
|
Belimumab SC 1 x 200 mg
n=19 Participants
Belimumab SC 200 mg x 1 injection on Day 0
|
Belimumab SC 2 x 120 mg Weekly
n=20 Participants
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
|
Belimumab SC 1 x 200 mg Weekly
n=20 Participants
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age Continuous
|
37.3 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
33.4 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
35.2 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
36.1 years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
33.7 years
STANDARD_DEVIATION 9.5 • n=21 Participants
|
37.4 years
STANDARD_DEVIATION 9.7 • n=10 Participants
|
35.5 years
STANDARD_DEVIATION 10.7 • n=115 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
65 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
53 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
19 participants
n=4 Participants
|
20 participants
n=21 Participants
|
20 participants
n=10 Participants
|
118 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70Population: The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Belimumab IV 240 mg
n=19 Participants
Belimumab IV 240 mg administered on Day 0
|
Belimumab SC 2 x 120 mg
n=19 Participants
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
|
Belimumab SC 1 x 240 mg
n=18 Participants
Belimumab SC 240 mg x 1 injection on Day 0
|
Belimumab SC 1 x 200 mg
n=18 Participants
Belimumab SC 200 mg x 1 injection on Day 0
|
Belimumab SC 2 x 120 mg Weekly
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
|
Belimumab SC 1 x 200 mg Weekly
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC)
|
0.09 days
Interval 0.05 to 0.3
|
3.9 days
Interval 0.9 to 9.8
|
4.9 days
Interval 2.9 to 13.9
|
5.9 days
Interval 1.9 to 13.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70Population: The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Belimumab IV 240 mg
n=19 Participants
Belimumab IV 240 mg administered on Day 0
|
Belimumab SC 2 x 120 mg
n=19 Participants
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
|
Belimumab SC 1 x 240 mg
n=18 Participants
Belimumab SC 240 mg x 1 injection on Day 0
|
Belimumab SC 1 x 200 mg
n=18 Participants
Belimumab SC 200 mg x 1 injection on Day 0
|
Belimumab SC 2 x 120 mg Weekly
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
|
Belimumab SC 1 x 200 mg Weekly
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
|
|---|---|---|---|---|---|---|
|
Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC
|
86.2 µg/mL
Geometric Coefficient of Variation 20.0
|
32.7 µg/mL
Geometric Coefficient of Variation 29.0
|
31.6 µg/mL
Geometric Coefficient of Variation 27.9
|
24.3 µg/mL
Geometric Coefficient of Variation 40.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70Population: The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.
Outcome measures
| Measure |
Belimumab IV 240 mg
n=19 Participants
Belimumab IV 240 mg administered on Day 0
|
Belimumab SC 2 x 120 mg
n=19 Participants
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
|
Belimumab SC 1 x 240 mg
n=18 Participants
Belimumab SC 240 mg x 1 injection on Day 0
|
Belimumab SC 1 x 200 mg
n=18 Participants
Belimumab SC 200 mg x 1 injection on Day 0
|
Belimumab SC 2 x 120 mg Weekly
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
|
Belimumab SC 1 x 200 mg Weekly
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following a Single Dose of Belimumab Given as IV or SC
|
1030 µg∙day/mL
Geometric Coefficient of Variation 32.1
|
788 µg∙day/mL
Geometric Coefficient of Variation 36.1
|
812 µg∙day/mL
Geometric Coefficient of Variation 36.2
|
612 µg∙day/mL
Geometric Coefficient of Variation 37.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70Population: The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.
Outcome measures
| Measure |
Belimumab IV 240 mg
n=19 Participants
Belimumab IV 240 mg administered on Day 0
|
Belimumab SC 2 x 120 mg
n=19 Participants
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
|
Belimumab SC 1 x 240 mg
n=18 Participants
Belimumab SC 240 mg x 1 injection on Day 0
|
Belimumab SC 1 x 200 mg
n=18 Participants
Belimumab SC 200 mg x 1 injection on Day 0
|
Belimumab SC 2 x 120 mg Weekly
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
|
Belimumab SC 1 x 200 mg Weekly
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
|
|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC
|
18.2 days
Standard Deviation 6.3
|
15.9 days
Standard Deviation 5.3
|
18.2 days
Standard Deviation 6.0
|
16.0 days
Standard Deviation 5.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70Population: The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability of belimumab administered by IV is compared to the bioavailability of belimumab administered via single-SC injection.
Outcome measures
| Measure |
Belimumab IV 240 mg
n=19 Participants
Belimumab IV 240 mg administered on Day 0
|
Belimumab SC 2 x 120 mg
n=19 Participants
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
|
Belimumab SC 1 x 240 mg
n=18 Participants
Belimumab SC 240 mg x 1 injection on Day 0
|
Belimumab SC 1 x 200 mg
n=18 Participants
Belimumab SC 200 mg x 1 injection on Day 0
|
Belimumab SC 2 x 120 mg Weekly
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
|
Belimumab SC 1 x 200 mg Weekly
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
|
|---|---|---|---|---|---|---|
|
Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC
|
NA percentage bioavailability
By definition, when a medication is administered IV, its bioavailability is 100%.
|
76.1 percentage bioavailability
Interval 64.5 to 89.9
|
81.8 percentage bioavailability
Interval 70.1 to 95.5
|
73.5 percentage bioavailability
Interval 59.7 to 90.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119Population: The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Belimumab IV 240 mg
n=17 Participants
Belimumab IV 240 mg administered on Day 0
|
Belimumab SC 2 x 120 mg
n=19 Participants
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
|
Belimumab SC 1 x 240 mg
Belimumab SC 240 mg x 1 injection on Day 0
|
Belimumab SC 1 x 200 mg
Belimumab SC 200 mg x 1 injection on Day 0
|
Belimumab SC 2 x 120 mg Weekly
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
|
Belimumab SC 1 x 200 mg Weekly
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Serum Drug Concentration (Tmax) Following Weekly (x 4) SC Injections of Belimumab
|
5.8 days
Standard Deviation 1.5
|
5.5 days
Standard Deviation 1.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119Population: The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Belimumab IV 240 mg
n=17 Participants
Belimumab IV 240 mg administered on Day 0
|
Belimumab SC 2 x 120 mg
n=19 Participants
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
|
Belimumab SC 1 x 240 mg
Belimumab SC 240 mg x 1 injection on Day 0
|
Belimumab SC 1 x 200 mg
Belimumab SC 200 mg x 1 injection on Day 0
|
Belimumab SC 2 x 120 mg Weekly
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
|
Belimumab SC 1 x 200 mg Weekly
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
|
|---|---|---|---|---|---|---|
|
Maximum Serum Drug Concentration (Cmax) Following Weekly (x 4) SC Injections of Belimumab
|
21.6 µg/mL
Geometric Coefficient of Variation 23.2
|
19.5 µg/mL
Geometric Coefficient of Variation 25.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119Population: The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.
Outcome measures
| Measure |
Belimumab IV 240 mg
n=17 Participants
Belimumab IV 240 mg administered on Day 0
|
Belimumab SC 2 x 120 mg
n=19 Participants
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
|
Belimumab SC 1 x 240 mg
Belimumab SC 240 mg x 1 injection on Day 0
|
Belimumab SC 1 x 200 mg
Belimumab SC 200 mg x 1 injection on Day 0
|
Belimumab SC 2 x 120 mg Weekly
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
|
Belimumab SC 1 x 200 mg Weekly
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following Weekly (x 4) SC Injections of Belimumab
|
763 µg∙day/mL
Geometric Coefficient of Variation 29.8
|
661 µg∙day/mL
Geometric Coefficient of Variation 31.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119Population: The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.
Outcome measures
| Measure |
Belimumab IV 240 mg
n=17 Participants
Belimumab IV 240 mg administered on Day 0
|
Belimumab SC 2 x 120 mg
n=19 Participants
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
|
Belimumab SC 1 x 240 mg
Belimumab SC 240 mg x 1 injection on Day 0
|
Belimumab SC 1 x 200 mg
Belimumab SC 200 mg x 1 injection on Day 0
|
Belimumab SC 2 x 120 mg Weekly
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
|
Belimumab SC 1 x 200 mg Weekly
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
|
|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2,Term) Following Weekly (x 4) SC Injections of Belimumab
|
20.3 days
Standard Deviation 5.2
|
19.8 days
Standard Deviation 4.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119Population: The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability following weekly (x 4) SC injections of belimumab was calculated by comparing the bioavailability of belimumab administered IV to the bioavailability of belimumab administered via 4 weekly SC injections.
Outcome measures
| Measure |
Belimumab IV 240 mg
n=17 Participants
Belimumab IV 240 mg administered on Day 0
|
Belimumab SC 2 x 120 mg
n=19 Participants
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
|
Belimumab SC 1 x 240 mg
Belimumab SC 240 mg x 1 injection on Day 0
|
Belimumab SC 1 x 200 mg
Belimumab SC 200 mg x 1 injection on Day 0
|
Belimumab SC 2 x 120 mg Weekly
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
|
Belimumab SC 1 x 200 mg Weekly
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
|
|---|---|---|---|---|---|---|
|
Absolute Bioavailability of Weekly (x 4) SC Injections of Belimumab
|
74.7 percentage bioavailability
Interval 62.6 to 89.1
|
77.9 percentage bioavailability
Interval 67.0 to 90.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 119Population: Analyses were performed on the as-treated population, defined as the set of all participants who received at least 1 partial or full dose of treatment with the assignment to treatment group that was based on the actual treatment administered to the participants.
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
Outcome measures
| Measure |
Belimumab IV 240 mg
n=19 Participants
Belimumab IV 240 mg administered on Day 0
|
Belimumab SC 2 x 120 mg
n=20 Participants
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
|
Belimumab SC 1 x 240 mg
n=20 Participants
Belimumab SC 240 mg x 1 injection on Day 0
|
Belimumab SC 1 x 200 mg
n=19 Participants
Belimumab SC 200 mg x 1 injection on Day 0
|
Belimumab SC 2 x 120 mg Weekly
n=20 Participants
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
|
Belimumab SC 1 x 200 mg Weekly
n=20 Participants
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Adverse Events
At least 1 AE
|
14 participants
|
11 participants
|
16 participants
|
14 participants
|
18 participants
|
19 participants
|
|
Number of Participants Who Experienced Adverse Events
At least 1 serious AE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants Who Experienced Adverse Events
An AE resulting in death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Belimumab IV 240 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Belimumab SC 2 x 120 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Belimumab SC 1 x 240 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Belimumab SC 1 x 200 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Belimumab SC 2 x 120 mg Weekly
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Belimumab SC 1 x 200 mg Weekly
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Belimumab IV 240 mg
n=19 participants at risk
Belimumab IV 240 mg administered on Day 0
|
Belimumab SC 2 x 120 mg
n=20 participants at risk
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
|
Belimumab SC 1 x 240 mg
n=20 participants at risk
Belimumab SC 240 mg x 1 injection on Day 0
|
Belimumab SC 1 x 200 mg
n=19 participants at risk
Belimumab SC 200 mg x 1 injection on Day 0
|
Belimumab SC 2 x 120 mg Weekly
n=20 participants at risk
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
|
Belimumab SC 1 x 200 mg Weekly
n=20 participants at risk
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
Other adverse events
| Measure |
Belimumab IV 240 mg
n=19 participants at risk
Belimumab IV 240 mg administered on Day 0
|
Belimumab SC 2 x 120 mg
n=20 participants at risk
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
|
Belimumab SC 1 x 240 mg
n=20 participants at risk
Belimumab SC 240 mg x 1 injection on Day 0
|
Belimumab SC 1 x 200 mg
n=19 participants at risk
Belimumab SC 200 mg x 1 injection on Day 0
|
Belimumab SC 2 x 120 mg Weekly
n=20 participants at risk
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
|
Belimumab SC 1 x 200 mg Weekly
n=20 participants at risk
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
External ear disorder
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Gastrointestinal disorders
Abdominal pain
|
15.8%
3/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
10.0%
2/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
10.5%
2/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
15.0%
3/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Gastrointestinal disorders
Proctalgia
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Gastrointestinal disorders
Toothache
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
General disorders
Chills
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
General disorders
Fatigue
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
General disorders
Injection site erythema
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
15.0%
3/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
15.0%
3/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
General disorders
Injection site haematoma
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
15.0%
3/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
10.0%
2/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
15.8%
3/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
General disorders
Injection site induration
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
General disorders
Injection site oedema
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
15.0%
3/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
General disorders
Injection site pain
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
15.0%
3/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
45.0%
9/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
42.1%
8/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
70.0%
14/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
70.0%
14/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
General disorders
Injection site pruritus
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
General disorders
Injection site rash
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
General disorders
Injection site scab
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
General disorders
Injection site swelling
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
15.0%
3/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
General disorders
Oedema peripheral
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
General disorders
Pain
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
General disorders
Vessel puncture site haemorrhage
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Infections and infestations
Gastroenteritis viral
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Infections and infestations
Herpes zoster infection neurological
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Infections and infestations
Hordeolum
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Infections and infestations
Oral herpes
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Infections and infestations
Pharyngitis
|
10.5%
2/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
10.0%
2/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
10.5%
2/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Infections and infestations
Rhinitis
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
10.5%
2/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Injury, poisoning and procedural complications
Splinter
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Investigations
Lymph node palpable
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
10.0%
2/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Nervous system disorders
Headache
|
15.8%
3/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
15.0%
3/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
26.3%
5/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
30.0%
6/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
15.0%
3/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Nervous system disorders
Presyncope
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Psychiatric disorders
Sleep talking
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Renal and urinary disorders
Chromaturia
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Reproductive system and breast disorders
Ovulation pain
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
20.0%
4/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Skin and subcutaneous tissue disorders
Papule
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
10.0%
2/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.5%
2/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.3%
1/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/19 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
0.00%
0/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
5.0%
1/20 • up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee For multi-center trials, no investigator will be authorized to publish study results from an individual center until the earlier of the multi-center trial results are published or 12 months after the end or termination of the multi-center trial at all sites. All manuscripts and abstracts must be submitted to the sponsor for review at least 30 days prior to submission for publication or for presentation at a scientific meeting. The sponsor may delay publication for up to 3 months.
- Publication restrictions are in place
Restriction type: OTHER