Trial Outcomes & Findings for PD of VAY736 in Patients With Primary Sjögren's Syndrome (NCT NCT02149420)
NCT ID: NCT02149420
Last Updated: 2021-10-04
Results Overview
The effect of VAY736 on clinical disease activity was measured by the change in ESSDAI (EULAR Sjögren's syndrome disease activity index) between baseline and week 12. The instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score (range 0-123). A reduction from baseline indicates improvement in patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Baseline, week 12
Results posted on
2021-10-04
Participant Flow
A total of 27 patients were enrolled and randomized into the study at one site in Germany.
The patients were enrolled in 2 sequential cohorts: Cohort 1: Six patients were randomized to receive a single dose iv of VAY736 at a dose of 3mg/kg or placebo at a 2:1 ratio. Cohort 2: Twenty one patients were randomized to receive a single iv dose of VAY736 at a dose of 10.0 mg/kg or 3.0 mg/kg or placebo at a 6:1:3 ratio.
Participant milestones
| Measure |
Placebo
single dose iv of Placebo (+ Option to receive Open label VAY736 10 mg/kg at Week 24)
|
VAY736 3 mg/kg
single dose iv of VAY736 at a dose of 3mg/kg
|
VAY736 10 mg/kg
single dose iv of VAY736 at a dose of 10mg/kg
|
|---|---|---|---|
|
Core Study
STARTED
|
9
|
6
|
12
|
|
Core Study
Safety Analysis Set
|
9
|
6
|
12
|
|
Core Study
PK Analysis Set
|
5
|
6
|
12
|
|
Core Study
PD (Pharmacodynamics) Analysis Set
|
9
|
6
|
12
|
|
Core Study
COMPLETED
|
9
|
5
|
10
|
|
Core Study
NOT COMPLETED
|
0
|
1
|
2
|
|
Open Label VAY736 10 mg/kg Extension
STARTED
|
5
|
0
|
0
|
|
Open Label VAY736 10 mg/kg Extension
COMPLETED
|
4
|
0
|
0
|
|
Open Label VAY736 10 mg/kg Extension
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
single dose iv of Placebo (+ Option to receive Open label VAY736 10 mg/kg at Week 24)
|
VAY736 3 mg/kg
single dose iv of VAY736 at a dose of 3mg/kg
|
VAY736 10 mg/kg
single dose iv of VAY736 at a dose of 10mg/kg
|
|---|---|---|---|
|
Core Study
Administrative problems
|
0
|
1
|
2
|
|
Open Label VAY736 10 mg/kg Extension
Administrative problems
|
1
|
0
|
0
|
Baseline Characteristics
PD of VAY736 in Patients With Primary Sjögren's Syndrome
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
single dose iv of Placebo
|
VAY736 3 mg/kg
n=6 Participants
single dose iv of VAY736 at a dose of 3mg/kg
|
VAY736 10 mg/kg
n=12 Participants
single dose iv of VAY736 at a dose of 10mg/kg
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.7 Years
STANDARD_DEVIATION 11.29 • n=5 Participants
|
46.8 Years
STANDARD_DEVIATION 8.75 • n=7 Participants
|
55.3 Years
STANDARD_DEVIATION 13.35 • n=5 Participants
|
50.5 Years
STANDARD_DEVIATION 12.16 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 12Population: PD analysis set
The effect of VAY736 on clinical disease activity was measured by the change in ESSDAI (EULAR Sjögren's syndrome disease activity index) between baseline and week 12. The instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score (range 0-123). A reduction from baseline indicates improvement in patients.
Outcome measures
| Measure |
Placebo
n=9 Participants
single dose iv of Placebo
|
VAY736 3 mg/kg
n=6 Participants
single dose iv of VAY736 at a dose of 3mg/kg
|
VAY736 10 mg/kg
n=12 Participants
single dose iv of VAY736 at a dose of 10mg/kg
|
VAY736 Combined
n=18 Participants
Combining VAY736 3mg/kg and VAY736 10mg/kg
|
|---|---|---|---|---|
|
Change in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
Baseline
|
11.1 units on a scale
Standard Deviation 4.08
|
14.5 units on a scale
Standard Deviation 9.44
|
11.5 units on a scale
Standard Deviation 4.38
|
12.5 units on a scale
Standard Deviation 6.38
|
|
Change in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
Week 12
|
10.2 units on a scale
Standard Deviation 5.29
|
10.7 units on a scale
Standard Deviation 7.69
|
10.0 units on a scale
Standard Deviation 5.36
|
10.2 units on a scale
Standard Deviation 6.01
|
|
Change in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
Change from Baseline to Week 12
|
-0.9 units on a scale
Standard Deviation 2.98
|
-3.8 units on a scale
Standard Deviation 8.66
|
-1.5 units on a scale
Standard Deviation 3.00
|
-2.3 units on a scale
Standard Deviation 5.40
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Safety analysis set
Number of subjects with Adverse Events during the double blind treatment period.
Outcome measures
| Measure |
Placebo
n=9 Participants
single dose iv of Placebo
|
VAY736 3 mg/kg
n=6 Participants
single dose iv of VAY736 at a dose of 3mg/kg
|
VAY736 10 mg/kg
n=12 Participants
single dose iv of VAY736 at a dose of 10mg/kg
|
VAY736 Combined
n=18 Participants
Combining VAY736 3mg/kg and VAY736 10mg/kg
|
|---|---|---|---|---|
|
Overall Incidence of Adverse Events
Subjects with Infusion related AEs
|
1 Participants
|
6 Participants
|
9 Participants
|
15 Participants
|
|
Overall Incidence of Adverse Events
Subjects with AEs
|
8 Participants
|
6 Participants
|
11 Participants
|
17 Participants
|
|
Overall Incidence of Adverse Events
Subjects with AEs within 24hr of infusion
|
2 Participants
|
6 Participants
|
11 Participants
|
17 Participants
|
|
Overall Incidence of Adverse Events
Subjects with AEs post 24hr of infusion
|
8 Participants
|
6 Participants
|
8 Participants
|
14 Participants
|
|
Overall Incidence of Adverse Events
Subjects with Study drug-related AEs
|
5 Participants
|
6 Participants
|
11 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline, week 12Population: PD analysis set
The ESSPRI is a patient self-reported outcome measure to assess dryness, limb pain, fatigue and mental fatigue, where each of the domains normally reported as 0 (not at all) to 10 (extremely severe). The final ESSPRI score is the average of three: dryness, pain and fatigue. A reduction from baseline indicates the improvement of symptoms. During the study all individual scores were reported as 1 to 10 instead. A linear transformation was reported to map the scores to the range of 0-10.
Outcome measures
| Measure |
Placebo
n=9 Participants
single dose iv of Placebo
|
VAY736 3 mg/kg
n=6 Participants
single dose iv of VAY736 at a dose of 3mg/kg
|
VAY736 10 mg/kg
n=12 Participants
single dose iv of VAY736 at a dose of 10mg/kg
|
VAY736 Combined
Combining VAY736 3mg/kg and VAY736 10mg/kg
|
|---|---|---|---|---|
|
Change in EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)
Baseline
|
5.967 units on a scale
Standard Deviation 2.2179
|
6.049 units on a scale
Standard Deviation 1.2759
|
6.235 units on a scale
Standard Deviation 1.5379
|
—
|
|
Change in EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)
Week 12
|
5.926 units on a scale
Standard Deviation 1.5822
|
6.173 units on a scale
Standard Deviation 1.4753
|
4.568 units on a scale
Standard Deviation 2.5966
|
—
|
|
Change in EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)
Change from Baseline to Week 12
|
-0.041 units on a scale
Standard Deviation 1.7805
|
0.123 units on a scale
Standard Deviation 1.0120
|
-1.667 units on a scale
Standard Deviation 1.8918
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 12Population: PD analysis set
The SF-36 is a 36-item, patient self-reported outcome measure (questionnaires) of patient health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. An increase from baseline in either component summary score indicates reduced disease burden.
Outcome measures
| Measure |
Placebo
n=9 Participants
single dose iv of Placebo
|
VAY736 3 mg/kg
n=6 Participants
single dose iv of VAY736 at a dose of 3mg/kg
|
VAY736 10 mg/kg
n=12 Participants
single dose iv of VAY736 at a dose of 10mg/kg
|
VAY736 Combined
Combining VAY736 3mg/kg and VAY736 10mg/kg
|
|---|---|---|---|---|
|
Change in Short Form (36) Health Survey (SF-36)
Physical component score: Baseline
|
46.886 units on a scale
Standard Deviation 6.3905
|
39.445 units on a scale
Standard Deviation 4.2857
|
46.015 units on a scale
Standard Deviation 9.3533
|
—
|
|
Change in Short Form (36) Health Survey (SF-36)
Physical component score: Week 12
|
44.788 units on a scale
Standard Deviation 8.3513
|
45.493 units on a scale
Standard Deviation 7.3060
|
47.671 units on a scale
Standard Deviation 9.2804
|
—
|
|
Change in Short Form (36) Health Survey (SF-36)
Physical component score: Change from Baseline
|
-2.098 units on a scale
Standard Deviation 7.9084
|
6.048 units on a scale
Standard Deviation 4.7189
|
1.656 units on a scale
Standard Deviation 5.4113
|
—
|
|
Change in Short Form (36) Health Survey (SF-36)
Mental component score: Baseline
|
36.913 units on a scale
Standard Deviation 15.2776
|
37.517 units on a scale
Standard Deviation 6.8994
|
43.628 units on a scale
Standard Deviation 11.3667
|
—
|
|
Change in Short Form (36) Health Survey (SF-36)
Mental component score: Week 12
|
41.012 units on a scale
Standard Deviation 13.2991
|
40.170 units on a scale
Standard Deviation 11.9815
|
46.700 units on a scale
Standard Deviation 11.3182
|
—
|
|
Change in Short Form (36) Health Survey (SF-36)
Mental component score: Change from Baseline
|
4.099 units on a scale
Standard Deviation 5.3361
|
2.653 units on a scale
Standard Deviation 17.1261
|
3.073 units on a scale
Standard Deviation 11.5823
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 12Population: PD analysis set
The MFI is a patient self-reported outcome measure (questionnaires) to assess fatigue covering the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each dimension has a posible range from 4-20. A reduction from baseline in MFI indicates improvement.
Outcome measures
| Measure |
Placebo
n=9 Participants
single dose iv of Placebo
|
VAY736 3 mg/kg
n=6 Participants
single dose iv of VAY736 at a dose of 3mg/kg
|
VAY736 10 mg/kg
n=12 Participants
single dose iv of VAY736 at a dose of 10mg/kg
|
VAY736 Combined
Combining VAY736 3mg/kg and VAY736 10mg/kg
|
|---|---|---|---|---|
|
Change in Multidimensional Fatigue Inventory (MFI)
General Fatigue: Baseline
|
14.0 units on a scale
Standard Deviation 4.72
|
17.0 units on a scale
Standard Deviation 2.37
|
15.9 units on a scale
Standard Deviation 3.34
|
—
|
|
Change in Multidimensional Fatigue Inventory (MFI)
General Fatigue: Week 12
|
12.8 units on a scale
Standard Deviation 4.84
|
14.2 units on a scale
Standard Deviation 6.40
|
12.4 units on a scale
Standard Deviation 3.99
|
—
|
|
Change in Multidimensional Fatigue Inventory (MFI)
General Fatigue: Change from Baseline
|
-1.2 units on a scale
Standard Deviation 1.64
|
-2.8 units on a scale
Standard Deviation 5.04
|
-3.5 units on a scale
Standard Deviation 4.12
|
—
|
|
Change in Multidimensional Fatigue Inventory (MFI)
Physical Fatigue: Baseline
|
12.9 units on a scale
Standard Deviation 4.14
|
15.7 units on a scale
Standard Deviation 2.34
|
14.2 units on a scale
Standard Deviation 3.41
|
—
|
|
Change in Multidimensional Fatigue Inventory (MFI)
Physical Fatigue: Week 12
|
12.2 units on a scale
Standard Deviation 3.99
|
11.2 units on a scale
Standard Deviation 5.15
|
10.4 units on a scale
Standard Deviation 4.66
|
—
|
|
Change in Multidimensional Fatigue Inventory (MFI)
Physical Fatigue: Change from Baseline
|
-0.7 units on a scale
Standard Deviation 1.32
|
-4.5 units on a scale
Standard Deviation 6.57
|
-3.8 units on a scale
Standard Deviation 4.77
|
—
|
|
Change in Multidimensional Fatigue Inventory (MFI)
Mental Fatigue: Baseline
|
11.9 units on a scale
Standard Deviation 4.78
|
14.3 units on a scale
Standard Deviation 3.78
|
13.0 units on a scale
Standard Deviation 3.28
|
—
|
|
Change in Multidimensional Fatigue Inventory (MFI)
Mental Fatigue: Week 12
|
11.7 units on a scale
Standard Deviation 4.12
|
11.3 units on a scale
Standard Deviation 4.18
|
9.8 units on a scale
Standard Deviation 5.17
|
—
|
|
Change in Multidimensional Fatigue Inventory (MFI)
Mental Fatigue: Change from Baseline
|
-0.2 units on a scale
Standard Deviation 2.95
|
-3.0 units on a scale
Standard Deviation 6.07
|
-3.2 units on a scale
Standard Deviation 5.84
|
—
|
|
Change in Multidimensional Fatigue Inventory (MFI)
Reduced motivation: Baseline
|
12.4 units on a scale
Standard Deviation 4.93
|
12.3 units on a scale
Standard Deviation 3.93
|
10.9 units on a scale
Standard Deviation 2.68
|
—
|
|
Change in Multidimensional Fatigue Inventory (MFI)
Reduced motivation: Week 12
|
12.0 units on a scale
Standard Deviation 5.32
|
10.0 units on a scale
Standard Deviation 4.52
|
9.8 units on a scale
Standard Deviation 4.97
|
—
|
|
Change in Multidimensional Fatigue Inventory (MFI)
Reduced motivation: Change from Baseline
|
-0.4 units on a scale
Standard Deviation 2.40
|
-2.3 units on a scale
Standard Deviation 4.50
|
-1.1 units on a scale
Standard Deviation 4.56
|
—
|
|
Change in Multidimensional Fatigue Inventory (MFI)
Reduced activity: Baseline
|
11.8 units on a scale
Standard Deviation 2.86
|
10.8 units on a scale
Standard Deviation 1.72
|
12.2 units on a scale
Standard Deviation 2.69
|
—
|
|
Change in Multidimensional Fatigue Inventory (MFI)
Reduced activity: Week 12
|
10.4 units on a scale
Standard Deviation 3.81
|
8.7 units on a scale
Standard Deviation 3.61
|
9.3 units on a scale
Standard Deviation 5.08
|
—
|
|
Change in Multidimensional Fatigue Inventory (MFI)
Reduced activity: Change from Baseline
|
-1.3 units on a scale
Standard Deviation 1.80
|
-2.2 units on a scale
Standard Deviation 4.83
|
-2.9 units on a scale
Standard Deviation 4.25
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 12Population: PD analysis set
The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).
Outcome measures
| Measure |
Placebo
n=9 Participants
single dose iv of Placebo
|
VAY736 3 mg/kg
n=6 Participants
single dose iv of VAY736 at a dose of 3mg/kg
|
VAY736 10 mg/kg
n=12 Participants
single dose iv of VAY736 at a dose of 10mg/kg
|
VAY736 Combined
Combining VAY736 3mg/kg and VAY736 10mg/kg
|
|---|---|---|---|---|
|
Change in the Physician's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS)
Baseline
|
57.3 units on a scale
Standard Deviation 17.73
|
66.2 units on a scale
Standard Deviation 17.53
|
65.0 units on a scale
Standard Deviation 11.74
|
—
|
|
Change in the Physician's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS)
Week 12
|
59.8 units on a scale
Standard Deviation 23.35
|
43.0 units on a scale
Standard Deviation 23.82
|
48.5 units on a scale
Standard Deviation 17.33
|
—
|
|
Change in the Physician's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS)
Change from Baseline to Week 12
|
2.4 units on a scale
Standard Deviation 12.21
|
-23.2 units on a scale
Standard Deviation 31.10
|
-16.5 units on a scale
Standard Deviation 18.96
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 12Population: PD analysis set
The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).
Outcome measures
| Measure |
Placebo
n=9 Participants
single dose iv of Placebo
|
VAY736 3 mg/kg
n=6 Participants
single dose iv of VAY736 at a dose of 3mg/kg
|
VAY736 10 mg/kg
n=12 Participants
single dose iv of VAY736 at a dose of 10mg/kg
|
VAY736 Combined
Combining VAY736 3mg/kg and VAY736 10mg/kg
|
|---|---|---|---|---|
|
Change in the Patient's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS)
Baseline
|
56.2 units on a scale
Standard Deviation 24.86
|
67.2 units on a scale
Standard Deviation 13.69
|
59.8 units on a scale
Standard Deviation 24.30
|
—
|
|
Change in the Patient's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS)
Week 12
|
55.2 units on a scale
Standard Deviation 21.57
|
44.2 units on a scale
Standard Deviation 22.75
|
40.8 units on a scale
Standard Deviation 20.49
|
—
|
|
Change in the Patient's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS)
Change from Baseline to Week 12
|
-1.0 units on a scale
Standard Deviation 17.71
|
-23.0 units on a scale
Standard Deviation 25.73
|
-19.0 units on a scale
Standard Deviation 21.08
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.Population: PK analysis set
The area under the serum concentration-time curve from time zero to infinity \[mass × time / volume\]. The concentration of VAY736 was measured in the serum.
Outcome measures
| Measure |
Placebo
n=6 Participants
single dose iv of Placebo
|
VAY736 3 mg/kg
n=12 Participants
single dose iv of VAY736 at a dose of 3mg/kg
|
VAY736 10 mg/kg
n=5 Participants
single dose iv of VAY736 at a dose of 10mg/kg
|
VAY736 Combined
Combining VAY736 3mg/kg and VAY736 10mg/kg
|
|---|---|---|---|---|
|
VAY736 Serum Concentration - AUCinf
|
389 day*ug/mL
Interval 186.0 to 457.0
|
1140 day*ug/mL
Interval 515.0 to 1610.0
|
971 day*ug/mL
Interval 849.0 to 1340.0
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.Population: PK analysis set
The area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration \[mass × time / volume\]. The concentration of VAY736 was measured in the serum.
Outcome measures
| Measure |
Placebo
n=6 Participants
single dose iv of Placebo
|
VAY736 3 mg/kg
n=12 Participants
single dose iv of VAY736 at a dose of 3mg/kg
|
VAY736 10 mg/kg
n=5 Participants
single dose iv of VAY736 at a dose of 10mg/kg
|
VAY736 Combined
Combining VAY736 3mg/kg and VAY736 10mg/kg
|
|---|---|---|---|---|
|
VAY736 Serum Concentration - AUClast
|
385 day*ug/mL
Interval 184.0 to 457.0
|
1140 day*ug/mL
Interval 514.0 to 1610.0
|
971 day*ug/mL
Interval 848.0 to 1340.0
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.Population: PK analysis set
The systemic (or total body) clearance from serum following intravenous administration \[volume / time\]. The concentration of VAY736 was measured in the serum.
Outcome measures
| Measure |
Placebo
n=6 Participants
single dose iv of Placebo
|
VAY736 3 mg/kg
n=12 Participants
single dose iv of VAY736 at a dose of 3mg/kg
|
VAY736 10 mg/kg
n=5 Participants
single dose iv of VAY736 at a dose of 10mg/kg
|
VAY736 Combined
Combining VAY736 3mg/kg and VAY736 10mg/kg
|
|---|---|---|---|---|
|
VAY736 Serum Concentration - CL
|
0.594 L/day
Interval 0.427 to 0.844
|
0.584 L/day
Interval 0.55 to 1.3
|
0.686 L/day
Interval 0.427 to 0.75
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.Population: PK analysis set
The observed maximum serum concentration following drug administration \[mass / volume\]. The concentration of VAY736 was measured in the serum.
Outcome measures
| Measure |
Placebo
n=6 Participants
single dose iv of Placebo
|
VAY736 3 mg/kg
n=12 Participants
single dose iv of VAY736 at a dose of 3mg/kg
|
VAY736 10 mg/kg
n=5 Participants
single dose iv of VAY736 at a dose of 10mg/kg
|
VAY736 Combined
Combining VAY736 3mg/kg and VAY736 10mg/kg
|
|---|---|---|---|---|
|
VAY736 Serum Concentration - Cmax
|
65.0 ug/mL
Interval 45.4 to 76.5
|
213 ug/mL
Interval 150.0 to 283.0
|
205 ug/mL
Interval 174.0 to 217.0
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.Population: PK analysis set
Apparent terminal half-life, determined as the ln2/lambda\_z or 0.693/lambda\_z. The concentration of VAY736 was measured in the serum.
Outcome measures
| Measure |
Placebo
n=6 Participants
single dose iv of Placebo
|
VAY736 3 mg/kg
n=12 Participants
single dose iv of VAY736 at a dose of 3mg/kg
|
VAY736 10 mg/kg
n=5 Participants
single dose iv of VAY736 at a dose of 10mg/kg
|
VAY736 Combined
Combining VAY736 3mg/kg and VAY736 10mg/kg
|
|---|---|---|---|---|
|
VAY736 Serum Concentration - T1/2
|
8.43 days
Interval 6.99 to 13.8
|
9.51 days
Interval 5.38 to 15.2
|
11.0 days
Interval 4.94 to 17.4
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.Population: PK analysis set
The time to reach the maximum concentration after drug administration \[time\]. The concentration of VAY736 was measured in the serum.
Outcome measures
| Measure |
Placebo
n=6 Participants
single dose iv of Placebo
|
VAY736 3 mg/kg
n=12 Participants
single dose iv of VAY736 at a dose of 3mg/kg
|
VAY736 10 mg/kg
n=5 Participants
single dose iv of VAY736 at a dose of 10mg/kg
|
VAY736 Combined
Combining VAY736 3mg/kg and VAY736 10mg/kg
|
|---|---|---|---|---|
|
VAY736 Serum Concentration - Tmax
|
2.03 hours
Interval 2.0 to 2.2
|
2.03 hours
Interval 2.0 to 2.3
|
2.10 hours
Interval 2.02 to 2.17
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.Population: PK analysis set
The volume of distribution during the terminal elimination phase following intravenous administration \[volume\]. The concentration of VAY736 was measured in the serum.
Outcome measures
| Measure |
Placebo
n=6 Participants
single dose iv of Placebo
|
VAY736 3 mg/kg
n=12 Participants
single dose iv of VAY736 at a dose of 3mg/kg
|
VAY736 10 mg/kg
n=5 Participants
single dose iv of VAY736 at a dose of 10mg/kg
|
VAY736 Combined
Combining VAY736 3mg/kg and VAY736 10mg/kg
|
|---|---|---|---|---|
|
VAY736 Serum Concentration - Vz
|
7.83 L
Interval 6.55 to 10.7
|
8.68 L
Interval 7.15 to 12.4
|
10.3 L
Interval 4.93 to 18.6
|
—
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
VAY736 3mg/kg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
VAY736 10mg/kg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Open Label VAY736 10mg/kg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=9 participants at risk
Placebo
|
VAY736 3mg/kg
n=6 participants at risk
VAY736 3mg/kg
|
VAY736 10mg/kg
n=12 participants at risk
VAY736 10mg/kg
|
Open Label VAY736 10mg/kg
n=5 participants at risk
Open label VAY736 10mg/kg
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis
|
11.1%
1/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Infections and infestations
Appendicitis
|
11.1%
1/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
Other adverse events
| Measure |
Placebo
n=9 participants at risk
Placebo
|
VAY736 3mg/kg
n=6 participants at risk
VAY736 3mg/kg
|
VAY736 10mg/kg
n=12 participants at risk
VAY736 10mg/kg
|
Open Label VAY736 10mg/kg
n=5 participants at risk
Open label VAY736 10mg/kg
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Eye disorders
Chalazion
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Eye disorders
Keratitis
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Eye disorders
Vitreous detachment
|
11.1%
1/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Gastrointestinal disorders
Auriculotemporal syndrome
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Gastrointestinal disorders
Noninfective sialoadenitis
|
11.1%
1/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
General disorders
Fatigue
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
General disorders
Non-cardiac chest pain
|
22.2%
2/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Infections and infestations
Cystitis
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Infections and infestations
Gastrointestinal infection
|
11.1%
1/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Infections and infestations
Nasopharyngitis
|
22.2%
2/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
83.3%
5/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
33.3%
4/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
100.0%
5/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Infections and infestations
Oral herpes
|
11.1%
1/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Infections and infestations
Otitis media
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Infections and infestations
Sinusitis
|
11.1%
1/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Infections and infestations
Tooth infection
|
11.1%
1/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Infections and infestations
Urogenital infection bacterial
|
11.1%
1/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.1%
1/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
100.0%
6/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
75.0%
9/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
60.0%
3/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
11.1%
1/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Injury, poisoning and procedural complications
Limb injury
|
11.1%
1/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
33.3%
2/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
11.1%
1/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
11.1%
1/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Nervous system disorders
Headache
|
33.3%
3/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
33.3%
2/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
2/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
1/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
11.1%
1/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).
All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER