Trial Outcomes & Findings for Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS) (NCT NCT02962895)
NCT ID: NCT02962895
Last Updated: 2025-01-07
Results Overview
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) 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 ranging 0-123. Higher scores on the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states. A negative change from baseline indicates improvement in disease status.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
190 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2025-01-07
Participant Flow
190 Patients were enrolled from 56 centers in 19 countries.
Patients who were in the placebo arm in Period 2 were switched to VAY736 - 150mg s.c. administration every 4 weeks in Period 3. At the end of Period 2, patients from the VAY736 300mg every 4 weeks arm were re-randomized to either i) double-blind VAY736 300mg every 4 weeks or ii) double-blind placebo every four weeks. All other patients proceeded directly from Period 2 to Period 4 (Safety Follow-Up).
Participant milestones
| Measure |
Placebo (Up to Week 24)
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 150 mg
Placebo patients in Period 2 switched to VAY736 - 150 mg s.c. administration every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
VAY736 300 mg - Placebo
VAY736 300 mg patients in Period 2 re-randomized to Placebo every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
VAY736 300 mg - VAY736 300 mg
VAY736 300 mg patients in Period 2 re-randomized to VAY736 300 mg every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
|---|---|---|---|---|---|---|---|
|
Period 2 (Randomized Set: Up to Week 24)
STARTED
|
49
|
47
|
47
|
47
|
0
|
0
|
0
|
|
Period 2 (Randomized Set: Up to Week 24)
COMPLETED
|
47
|
42
|
43
|
46
|
0
|
0
|
0
|
|
Period 2 (Randomized Set: Up to Week 24)
NOT COMPLETED
|
2
|
5
|
4
|
1
|
0
|
0
|
0
|
|
Period 3 (Randomized Set / Weeks: 24-52)
STARTED
|
0
|
0
|
0
|
0
|
47
|
22
|
21
|
|
Period 3 (Randomized Set / Weeks: 24-52)
COMPLETED
|
0
|
0
|
0
|
0
|
42
|
22
|
17
|
|
Period 3 (Randomized Set / Weeks: 24-52)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
5
|
0
|
4
|
|
Period 4 (Safety Follow-Up)
STARTED
|
2
|
47
|
47
|
4
|
46
|
22
|
20
|
|
Period 4 (Safety Follow-Up)
COMPLETED
|
2
|
41
|
43
|
1
|
42
|
20
|
20
|
|
Period 4 (Safety Follow-Up)
NOT COMPLETED
|
0
|
6
|
4
|
3
|
4
|
2
|
0
|
Reasons for withdrawal
| Measure |
Placebo (Up to Week 24)
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 150 mg
Placebo patients in Period 2 switched to VAY736 - 150 mg s.c. administration every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
VAY736 300 mg - Placebo
VAY736 300 mg patients in Period 2 re-randomized to Placebo every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
VAY736 300 mg - VAY736 300 mg
VAY736 300 mg patients in Period 2 re-randomized to VAY736 300 mg every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
|---|---|---|---|---|---|---|---|
|
Period 2 (Randomized Set: Up to Week 24)
Withdrawal by Subject
|
1
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Period 2 (Randomized Set: Up to Week 24)
Withdrawal of Informed Consent
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Randomized Set: Up to Week 24)
Adverse Event
|
0
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Period 2 (Randomized Set: Up to Week 24)
New therapy for indication
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Randomized Set: Up to Week 24)
Non-compliance with treatment
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Randomized Set: Up to Week 24)
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period 3 (Randomized Set / Weeks: 24-52)
Patient/guardian decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 3 (Randomized Set / Weeks: 24-52)
Adverse Event
|
0
|
0
|
0
|
0
|
5
|
0
|
2
|
|
Period 3 (Randomized Set / Weeks: 24-52)
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 4 (Safety Follow-Up)
Lack of Efficacy
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 4 (Safety Follow-Up)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 4 (Safety Follow-Up)
New therapy for indication
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 4 (Safety Follow-Up)
Withdrawal of informed consent
|
0
|
3
|
1
|
2
|
0
|
0
|
0
|
|
Period 4 (Safety Follow-Up)
Withdrawal by Subject
|
0
|
2
|
3
|
1
|
2
|
2
|
0
|
Baseline Characteristics
Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)
Baseline characteristics by cohort
| Measure |
Placebo (Up to Week 24)
n=49 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.9 Years
STANDARD_DEVIATION 12.44 • n=99 Participants
|
52.5 Years
STANDARD_DEVIATION 13.64 • n=107 Participants
|
51.0 Years
STANDARD_DEVIATION 11.12 • n=206 Participants
|
49.1 Years
STANDARD_DEVIATION 15.41 • n=7 Participants
|
50.9 Years
STANDARD_DEVIATION 13.48 • n=31 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
180 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
44 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
165 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set (FAS)
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) 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 ranging 0-123. Higher scores on the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states. A negative change from baseline indicates improvement in disease status.
Outcome measures
| Measure |
Placebo (Up to Week 24)
n=49 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 300 mg - VAY736 300 mg
VAY736 300 mg patients in Period 2 re-randomized to VAY736 300 mg every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
|---|---|---|---|---|---|
|
Least Squares Mean Change From Baseline in ESSDAI Score at Week 24
|
-6.39 Scores on a scale
Standard Error 0.808
|
-5.64 Scores on a scale
Standard Error 0.850
|
-6.93 Scores on a scale
Standard Error 0.836
|
-8.30 Scores on a scale
Standard Error 0.828
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) 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 ranging 0-123. Higher scores on the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states. A negative change from baseline indicates improvement in disease status.
Outcome measures
| Measure |
Placebo (Up to Week 24)
n=49 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 300 mg - VAY736 300 mg
VAY736 300 mg patients in Period 2 re-randomized to VAY736 300 mg every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
|---|---|---|---|---|---|
|
Least Squares Mean Change From Baseline in ESSDAI Score at Weeks 4, 8, 12, and 16
Week 4
|
-3.73 Scores on a scale
Standard Error 0.626
|
-2.28 Scores on a scale
Standard Error 0.661
|
-3.37 Scores on a scale
Standard Error 0.638
|
-4.53 Scores on a scale
Standard Error 0.651
|
—
|
|
Least Squares Mean Change From Baseline in ESSDAI Score at Weeks 4, 8, 12, and 16
Week 8
|
-4.13 Scores on a scale
Standard Error 0.704
|
-4.65 Scores on a scale
Standard Error 0.733
|
-4.73 Scores on a scale
Standard Error 0.720
|
-6.38 Scores on a scale
Standard Error 0.717
|
—
|
|
Least Squares Mean Change From Baseline in ESSDAI Score at Weeks 4, 8, 12, and 16
Week 12
|
-5.45 Scores on a scale
Standard Error 0.721
|
-4.89 Scores on a scale
Standard Error 0.762
|
-5.69 Scores on a scale
Standard Error 0.739
|
-6.64 Scores on a scale
Standard Error 0.739
|
—
|
|
Least Squares Mean Change From Baseline in ESSDAI Score at Weeks 4, 8, 12, and 16
Week 16
|
-6.08 Scores on a scale
Standard Error 0.818
|
-5.67 Scores on a scale
Standard Error 0.852
|
-6.17 Scores on a scale
Standard Error 0.835
|
-6.99 Scores on a scale
Standard Error 0.836
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set (FAS)
The EULAR Sjörgen's Syndrome Patient Reported Index (ESSPRI) is an established disease outcome measure for Sjögren's syndrome that is calculated by averaging the scales for pain, fatigue and dryness. The total score is the mean score of the 3 scales and ranges between 0 and 10 with higher values indicating more severity of symptoms. A negative change from baseline is a favorable outcome.
Outcome measures
| Measure |
Placebo (Up to Week 24)
n=49 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 300 mg - VAY736 300 mg
VAY736 300 mg patients in Period 2 re-randomized to VAY736 300 mg every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
|---|---|---|---|---|---|
|
Least Squares Mean Change From Baseline in ESSPRI Score at Week 24
|
-1.71 Scores on a scale
Standard Error 0.288
|
-1.39 Scores on a scale
Standard Error 0.304
|
-1.70 Scores on a scale
Standard Error 0.301
|
-1.77 Scores on a scale
Standard Error 0.295
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.
The EULAR Sjörgen's Syndrome Patient Reported Index (ESSPRI) is an established disease outcome measure for Sjögren's syndrome that is calculated by averaging the scales for pain, fatigue and dryness. The total score is the mean score of the 3 scales and ranges between 0 and 10 with higher values indicating more severity of symptoms. A negative change from baseline is a favorable outcome.
Outcome measures
| Measure |
Placebo (Up to Week 24)
n=49 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 300 mg - VAY736 300 mg
VAY736 300 mg patients in Period 2 re-randomized to VAY736 300 mg every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
|---|---|---|---|---|---|
|
Least Squares Mean Change From Baseline in ESSPRI Score at Weeks 4, 8, 12 and 16
Week 16
|
-1.77 Scores on a scale
Standard Error 0.263
|
-1.27 Scores on a scale
Standard Error 0.275
|
-1.55 Scores on a scale
Standard Error 0.271
|
-1.55 Scores on a scale
Standard Error 0.270
|
—
|
|
Least Squares Mean Change From Baseline in ESSPRI Score at Weeks 4, 8, 12 and 16
Week 4
|
-0.54 Scores on a scale
Standard Error 0.236
|
-0.67 Scores on a scale
Standard Error 0.247
|
-0.80 Scores on a scale
Standard Error 0.241
|
-0.88 Scores on a scale
Standard Error 0.242
|
—
|
|
Least Squares Mean Change From Baseline in ESSPRI Score at Weeks 4, 8, 12 and 16
Week 8
|
-0.94 Scores on a scale
Standard Error 0.242
|
-0.84 Scores on a scale
Standard Error 0.255
|
-1.06 Scores on a scale
Standard Error 0.251
|
-1.8 Scores on a scale
Standard Error 0.248
|
—
|
|
Least Squares Mean Change From Baseline in ESSPRI Score at Weeks 4, 8, 12 and 16
Week 12
|
-1.42 Scores on a scale
Standard Error 0.265
|
-1.36 Scores on a scale
Standard Error 0.279
|
-1.44 Scores on a scale
Standard Error 0.273
|
-1.23 Scores on a scale
Standard Error 0.270
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set (FAS)
The Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F v4) is a short, 13-item, easy-to-administer tool that measures an individual's level of fatigue during their usual daily activities over the previous week. The level of fatigue is measured on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The global score ranges between 0 and 52, with higher scores indicating less fatigue.
Outcome measures
| Measure |
Placebo (Up to Week 24)
n=49 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 300 mg - VAY736 300 mg
VAY736 300 mg patients in Period 2 re-randomized to VAY736 300 mg every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
|---|---|---|---|---|---|
|
Least Squares Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Score Over 24 Weeks
|
9.05 Scores on a scale
Standard Error 1.404
|
7.12 Scores on a scale
Standard Error 1.502
|
6.48 Scores on a scale
Standard Error 1.518
|
9.36 Scores on a scale
Standard Error 1.436
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12 and 16Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.
The Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F v4) is a short, 13-item, easy-to-administer tool that measures an individual's level of fatigue during their usual daily activities over the previous week. The level of fatigue is measured on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The global score ranges between 0 and 52, with higher scores indicating less fatigue.
Outcome measures
| Measure |
Placebo (Up to Week 24)
n=48 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=42 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=39 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=46 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 300 mg - VAY736 300 mg
VAY736 300 mg patients in Period 2 re-randomized to VAY736 300 mg every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
|---|---|---|---|---|---|
|
Least Squares Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Score at Weeks 4, 8, 12 and 16
Week 4
|
3.78 Scores on a scale
Standard Deviation 1.175
|
6.32 Scores on a scale
Standard Deviation 1.239
|
3.12 Scores on a scale
Standard Deviation 1.229
|
3.39 Scores on a scale
Standard Deviation 1.203
|
—
|
|
Least Squares Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Score at Weeks 4, 8, 12 and 16
Week 8
|
5.49 Scores on a scale
Standard Deviation 1.222
|
6.36 Scores on a scale
Standard Deviation 1.297
|
3.93 Scores on a scale
Standard Deviation 1.303
|
5.98 Scores on a scale
Standard Deviation 1.250
|
—
|
|
Least Squares Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Score at Weeks 4, 8, 12 and 16
Week 12
|
6.25 Scores on a scale
Standard Deviation 1.349
|
8.17 Scores on a scale
Standard Deviation 1.429
|
5.73 Scores on a scale
Standard Deviation 1.427
|
6.05 Scores on a scale
Standard Deviation 1.374
|
—
|
|
Least Squares Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Score at Weeks 4, 8, 12 and 16
Week 16
|
8.56 Scores on a scale
Standard Deviation 1.284
|
7.09 Scores on a scale
Standard Deviation 1.357
|
6.86 Scores on a scale
Standard Deviation 1.359
|
8.30 Scores on a scale
Standard Deviation 1.318
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full analysis set (FAS)
The SF36 includes 8 scale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) and two summary scores, the physical and mental component scores. The first four and last four scales comprise physical and mental component scores, respectively. The range of scores of the physical component (PCS) and mental component (MCS) is 0 (lowest or worst possible level of functioning) to 100 (highest or best possible level of functioning).
Outcome measures
| Measure |
Placebo (Up to Week 24)
n=49 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 300 mg - VAY736 300 mg
VAY736 300 mg patients in Period 2 re-randomized to VAY736 300 mg every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
|---|---|---|---|---|---|
|
Least Squares Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component (PCS) and Mental Component (MCS) Over 24 Weeks
Physical Component Score
|
3.66 Scores on a scale
Standard Error 0.952
|
4.79 Scores on a scale
Standard Error 1.019
|
2.66 Scores on a scale
Standard Error 1.026
|
5.50 Scores on a scale
Standard Error 0.972
|
—
|
|
Least Squares Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component (PCS) and Mental Component (MCS) Over 24 Weeks
Mental Component Score
|
4.63 Scores on a scale
Standard Error 1.259
|
3.61 Scores on a scale
Standard Error 1.350
|
5.31 Scores on a scale
Standard Error 1.367
|
5.63 Scores on a scale
Standard Error 1.286
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12 and 16Population: Full Analysis Set (FAS): Only participants with a value at both Baseline and post-baseline visit included.
The SF36 includes 8 scale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) and two summary scores, the physical and mental component scores. The first four and last four scales comprise physical and mental component scores, respectively. The range of scores of the physical component (PCS) and mental component (MCS) is 0 (lowest or worst possible level of functioning) to 100 (highest or best possible level of functioning).
Outcome measures
| Measure |
Placebo (Up to Week 24)
n=49 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 300 mg - VAY736 300 mg
VAY736 300 mg patients in Period 2 re-randomized to VAY736 300 mg every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
|---|---|---|---|---|---|
|
Least Squares Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component (PCS) and Mental Component (MCS) at Weeks 4, 8, 12 and 16
Week 4 - Mental Component Score
|
0.49 Scores on a scale
Standard Error 1.091
|
1.89 Scores on a scale
Standard Error 1.151
|
2.46 Scores on a scale
Standard Error 1.149
|
2.18 Scores on a scale
Standard Error 1.116
|
—
|
|
Least Squares Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component (PCS) and Mental Component (MCS) at Weeks 4, 8, 12 and 16
Week 8 - Mental Component Score
|
2.65 Scores on a scale
Standard Error 2.267
|
3.80 Scores on a scale
Standard Error 1.341
|
4.65 Scores on a scale
Standard Error 1.363
|
3.35 Scores on a scale
Standard Error 1.294
|
—
|
|
Least Squares Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component (PCS) and Mental Component (MCS) at Weeks 4, 8, 12 and 16
Week 12 - Mental Component Score
|
2.89 Scores on a scale
Standard Error 1.188
|
5.42 Scores on a scale
Standard Error 1.264
|
3.94 Scores on a scale
Standard Error 1.265
|
4.59 Scores on a scale
Standard Error 1.207
|
—
|
|
Least Squares Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component (PCS) and Mental Component (MCS) at Weeks 4, 8, 12 and 16
Week 16 - Mental Component Score
|
4.60 Scores on a scale
Standard Error 1.214
|
3.00 Scores on a scale
Standard Error 1.281
|
5.57 Scores on a scale
Standard Error 1.291
|
5.46 Scores on a scale
Standard Error 1.247
|
—
|
|
Least Squares Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component (PCS) and Mental Component (MCS) at Weeks 4, 8, 12 and 16
Week 4 - Physical Component Score
|
3.35 Scores on a scale
Standard Error 0.844
|
3.94 Scores on a scale
Standard Error 0.889
|
1.14 Scores on a scale
Standard Error 0.878
|
1.98 Scores on a scale
Standard Error 0.863
|
—
|
|
Least Squares Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component (PCS) and Mental Component (MCS) at Weeks 4, 8, 12 and 16
Week 8 - Physical Component Score
|
3.83 Scores on a scale
Standard Error 0.894
|
4.56 Scores on a scale
Standard Error 0.949
|
3.48 Scores on a scale
Standard Error 0.941
|
3.47 Scores on a scale
Standard Error 0.909
|
—
|
|
Least Squares Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component (PCS) and Mental Component (MCS) at Weeks 4, 8, 12 and 16
Week 12 - Physical Component Score
|
3.83 Scores on a scale
Standard Error 0.894
|
4.56 Scores on a scale
Standard Error 0.949
|
3.48 Scores on a scale
Standard Error 0.941
|
3.47 Scores on a scale
Standard Error 0.909
|
—
|
|
Least Squares Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component (PCS) and Mental Component (MCS) at Weeks 4, 8, 12 and 16
Week 16 - Physical Component Score
|
4.72 Scores on a scale
Standard Error 0.968
|
4.67 Scores on a scale
Standard Error 1.020
|
3.32 Scores on a scale
Standard Error 1.021
|
4.57 Scores on a scale
Standard Error 0.993
|
—
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: Full analysis set (FAS)
Physician global assessment of overall disease activity (PhGA) was performed using a 100 mm visual analogue scale (VAS) ranging from no disease activity (score 0) to maximal disease activity (score 100), after the question "Considering all the ways the disease affects your patient, draw a line on the scale for how well his or her condition is today". A negative change from baseline is a favourable outcome.
Outcome measures
| Measure |
Placebo (Up to Week 24)
n=49 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 300 mg - VAY736 300 mg
VAY736 300 mg patients in Period 2 re-randomized to VAY736 300 mg every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
|---|---|---|---|---|---|
|
Least Squares Mean Change From Baseline in Physician's Global Assessment (PhGA) of Patient's Overall Disease Activity Using Patient Visual Analog Scale (VAS) Over 24 Weeks
|
-23.64 Scores on a scale
Standard Error 2.601
|
-27.81 Scores on a scale
Standard Error 2.751
|
-28.13 Scores on a scale
Standard Error 2.700
|
-31.99 Scores on a scale
Standard Error 2.630
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12 and 16Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.
Physician global assessment of overall disease activity (PhGA) was performed using a 100 mm visual analogue scale (VAS) ranging from no disease activity (score 0) to maximal disease activity (score 100), after the question "Considering all the ways the disease affects your patient, draw a line on the scale for how well his or her condition is today". A negative change from baseline is a favourable outcome.
Outcome measures
| Measure |
Placebo (Up to Week 24)
n=49 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 300 mg - VAY736 300 mg
VAY736 300 mg patients in Period 2 re-randomized to VAY736 300 mg every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
|---|---|---|---|---|---|
|
Least Squares Mean Change From Baseline in Physician's Global Assessment (PhGA) of Patient's Overall Disease Activity Using Patient Visual Analog Scale (VAS) at Weeks 4, 8, 12 and 16
Week 4
|
-12.49 Scores on a scale
Standard Error 2.327
|
-10.50 Scores on a scale
Standard Error 2.445
|
-12.38 Scores on a scale
Standard Error 2.361
|
-18.67 Scores on a scale
Standard Error 2.367
|
—
|
|
Least Squares Mean Change From Baseline in Physician's Global Assessment (PhGA) of Patient's Overall Disease Activity Using Patient Visual Analog Scale (VAS) at Weeks 4, 8, 12 and 16
Week 8
|
-18.54 Scores on a scale
Standard Error 2.239
|
-16.53 Scores on a scale
Standard Error 2.338
|
-22.12 Scores on a scale
Standard Error 2.374
|
-24.85 Scores on a scale
Standard Error 2.289
|
—
|
|
Least Squares Mean Change From Baseline in Physician's Global Assessment (PhGA) of Patient's Overall Disease Activity Using Patient Visual Analog Scale (VAS) at Weeks 4, 8, 12 and 16
Week 12
|
-21.01 Scores on a scale
Standard Error 2.299
|
-20.72 Scores on a scale
Standard Error 2.413
|
-25.35 Scores on a scale
Standard Error 2.341
|
-27.25 Scores on a scale
Standard Error 2.305
|
—
|
|
Least Squares Mean Change From Baseline in Physician's Global Assessment (PhGA) of Patient's Overall Disease Activity Using Patient Visual Analog Scale (VAS) at Weeks 4, 8, 12 and 16
Week 16
|
-19.44 Scores on a scale
Standard Error 2.572
|
-24.49 Scores on a scale
Standard Error 2.687
|
-24.77 Scores on a scale
Standard Error 2.676
|
-25.77 Scores on a scale
Standard Error 2.633
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16 and 24Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.
The PaGA of disease activity was performed using a 100 mm Visual Analog Scale (VAS) ranging from 0 (no disease activity) to 100 (maximal disease activity), in response to the question "Considering all the ways Sjögren's syndrome affects you, please draw a line on the scale to indicate how well you are doing today". A negative change from baseline is a favourable outcome.
Outcome measures
| Measure |
Placebo (Up to Week 24)
n=49 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 300 mg - VAY736 300 mg
VAY736 300 mg patients in Period 2 re-randomized to VAY736 300 mg every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
|---|---|---|---|---|---|
|
Patient's Global Assessment (PaGA) Score at Weeks 4, 8, 12, 16 and 24
Week 24
|
-15.11 Scores on a scale
Standard Error 3.405
|
-12.83 Scores on a scale
Standard Error 3.648
|
-11.85 Scores on a scale
Standard Error 3.704
|
-19.87 Scores on a scale
Standard Error 3.470
|
—
|
|
Patient's Global Assessment (PaGA) Score at Weeks 4, 8, 12, 16 and 24
Week 4
|
-9.42 Scores on a scale
Standard Error 2.850
|
-10.02 Scores on a scale
Standard Error 2.992
|
-5.96 Scores on a scale
Standard Error 2.969
|
-8.96 Scores on a scale
Standard Error 2.906
|
—
|
|
Patient's Global Assessment (PaGA) Score at Weeks 4, 8, 12, 16 and 24
Week 8
|
-9.74 Scores on a scale
Standard Error 3.035
|
-11.48 Scores on a scale
Standard Error 3.214
|
-8.70 Scores on a scale
Standard Error 3.271
|
-15.27 Scores on a scale
Standard Error 3.091
|
—
|
|
Patient's Global Assessment (PaGA) Score at Weeks 4, 8, 12, 16 and 24
Week 12
|
-11.45 Scores on a scale
Standard Error 3.064
|
-17.51 Scores on a scale
Standard Error 3.244
|
-11.73 Scores on a scale
Standard Error 3.234
|
-13.57 Scores on a scale
Standard Error 3.105
|
—
|
|
Patient's Global Assessment (PaGA) Score at Weeks 4, 8, 12, 16 and 24
Week 16
|
-16.26 Scores on a scale
Standard Error 3.194
|
-17.56 Scores on a scale
Standard Error 3.361
|
-14.86 Scores on a scale
Standard Error 3.375
|
-15.78 Scores on a scale
Standard Error 3.271
|
—
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: Full analysis set (FAS): The overall number of participants analyzed represents the FAS. The number analyzed per row represents participants with data available at each assessment.
Change from baseline in salivary flow rate (unstimulated and stimulated) at 24 weeks as compared to placebo. Unstimulated saliva is a mix of serous and mucous secretions coming primarily from the submandibular and minor salivary glands. The parotid gland produces the largest volume of stimulated saliva. Stimulated saliva accounts for 80-90% of daily salivary production.
Outcome measures
| Measure |
Placebo (Up to Week 24)
n=49 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 300 mg - VAY736 300 mg
VAY736 300 mg patients in Period 2 re-randomized to VAY736 300 mg every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
|---|---|---|---|---|---|
|
Least Squares Mean Change From Baseline in Salivary Flow Rate at Week 24
Stimulated
|
0.05 mL/min
Standard Error 0.067
|
0.16 mL/min
Standard Error 0.074
|
0.18 mL/min
Standard Error 0.071
|
0.25 mL/min
Standard Error 0.98
|
—
|
|
Least Squares Mean Change From Baseline in Salivary Flow Rate at Week 24
Unstimulated
|
0.00 mL/min
Standard Error 0.030
|
0.01 mL/min
Standard Error 0.034
|
-0.00 mL/min
Standard Error 0.032
|
-0.01 mL/min
Standard Error 0.031
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 28Population: Full analysis set (FAS): patients were analyzed according to the first treatment received (at Period 2, 24 weeks). VAY736 300 mg - Placebo included patients who discontinued in Period 2 and entered Period 4 directly and patients who completed Period 2 and were re-randomized to placebo. Only patients with baseline measurement and at least one measurement post-baseline were included.
B-cell counts were measured before, during and after treatment with VAY736. After stopping VAY736 treatment they were used to monitor patients for time to recovery of adequate CD19+ B cell counts prior to discharge from the study. Change from baseline in B-cell counts before, during and after treatment with VAY736 as well as the time to recover to baseline like values (defined as at least 80% of baseline counts or \>= 50 cells/μL) were analyzed by descriptive statistics. Baseline was defined as the last assessment performed on or prior to the date of administration of the first dose of study treatment.
Outcome measures
| Measure |
Placebo (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=49 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=26 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 300 mg - VAY736 300 mg
n=21 Participants
VAY736 300 mg patients in Period 2 re-randomized to VAY736 300 mg every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Whole Blood CD19+ B-cell Counts.
Week 24
|
-88.00 Percent change
Standard Error 5.784
|
-99.07 Percent change
Standard Error 5.812
|
3.29 Percent change
Standard Error 5.674
|
-103.0 Percent change
Standard Error 8.198
|
-94.20 Percent change
Standard Error 8.098
|
|
Percent Change From Baseline in Whole Blood CD19+ B-cell Counts.
Week 28
|
—
|
—
|
-97.06 Percent change
Standard Error 5.732
|
-105.3 Percent change
Standard Error 9.145
|
-91.80 Percent change
Standard Error 8.272
|
SECONDARY outcome
Timeframe: Up to two years from last dose patient received.Population: Full analysis set (FAS): patients were analyzed according to the first treatment received (at Period 2, 24 weeks). VAY736 300 mg - Placebo included patients who discontinued in Period 2 and entered Period 4 directly and patients who completed Period 2 and were re-randomized to placebo. Only patients with baseline measurement and at least one measurement post-baseline were included.
B-cell counts were measured before, during and after treatment with VAY736. After stopping VAY736 treatment they were used to monitor patients for time to recovery of adequate CD19+ B cell counts prior to discharge from the study. Change from baseline in B-cell counts before, during and after treatment with VAY736 as well as the time to recover to baseline like values (defined as at least 80% of baseline counts or \>= 50 cells/μL) were analyzed by descriptive statistics. Baseline was defined as the last assessment performed on or prior to the date of administration of the first dose of study treatment.
Outcome measures
| Measure |
Placebo (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=49 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=26 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 300 mg - VAY736 300 mg
n=21 Participants
VAY736 300 mg patients in Period 2 re-randomized to VAY736 300 mg every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
|---|---|---|---|---|---|
|
Kaplan-Meier Analysis for Time to Recovery to Baseline Like Values for B-cell Counts
|
3.8 months
Interval 2.7 to 5.2
|
4.8 months
Interval 4.7 to 6.6
|
6.8 months
Interval 5.0 to 9.2
|
8.4 months
Interval 6.8 to 9.1
|
6.5 months
Interval 4.9 to 7.5
|
SECONDARY outcome
Timeframe: baseline to week 24, then week 28Population: Safety set (SAF): included all patients who received at least one dose of study medication. Patients were analyzed according to treatment received and the actual stratum at baseline. The safety set was used in the analysis of all safety variables.
Pharmacokinetic Concentrations This outcome only applies to patients who received at least one dose of VAY739 (so not applicable to placebo)
Outcome measures
| Measure |
Placebo (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=47 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=4 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=21 Participants
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 300 mg - VAY736 300 mg
n=22 Participants
VAY736 300 mg patients in Period 2 re-randomized to VAY736 300 mg every 4 weeks in Period 3 (Period 3 = 28 weeks)
|
|---|---|---|---|---|---|
|
Peak Serum Concentration of VAY736
|
0.0747 ug/mL
Standard Deviation 0.203
|
0.475 ug/mL
Standard Deviation 0.380
|
1.46 ug/mL
Standard Deviation 0.596
|
2.15 ug/mL
Standard Deviation 1.47
|
1.94 ug/mL
Standard Deviation 1.53
|
Adverse Events
Placebo (Up to Week 24)
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
VAY736 - 5 mg (Up to Week 24)
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
VAY736 - 50 mg (Up to Week 24)
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
VAY736 - 300 mg (Up to Week 24)
Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths
Any VAY736 (Up to Week 24)
Serious events: 3 serious events
Other events: 115 other events
Deaths: 0 deaths
ALL (Up to Week 24)
Serious events: 6 serious events
Other events: 148 other events
Deaths: 0 deaths
VAY736 - 5 mg 24 Weeks (Periods 2 and 4)
Serious events: 3 serious events
Other events: 41 other events
Deaths: 0 deaths
VAY736 - 50 mg 24 Weeks (Periods 2 and 4)
Serious events: 7 serious events
Other events: 37 other events
Deaths: 0 deaths
VAY736 - 150 mg 28 Weeks (Periods 3 and 4)
Serious events: 9 serious events
Other events: 41 other events
Deaths: 0 deaths
VAY736 - 300 mg 24 Weeks (Entire Study)
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
VAY736 - 300 mg 52 Weeks (Entire Study)
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Any VAY736 - 300 mg (Periods 2, 3 and 4)
Serious events: 10 serious events
Other events: 44 other events
Deaths: 0 deaths
Any VAY736 (Periods 2, 3 and 4)
Serious events: 29 serious events
Other events: 163 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Up to Week 24)
n=49 participants at risk
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=47 participants at risk
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=47 participants at risk
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=47 participants at risk
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
Any VAY736 (Up to Week 24)
n=141 participants at risk
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
ALL (Up to Week 24)
n=190 participants at risk
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg 24 Weeks (Periods 2 and 4)
n=47 participants at risk
All events reported from start of VAY736 - 5 mg dose in Period 2 (blinded treatment period of 24 weeks) and in the post treatment safety follow-up (Period 4)
|
VAY736 - 50 mg 24 Weeks (Periods 2 and 4)
n=47 participants at risk
All events reported from start of VAY736 - 50 mg dose in Period 2 (blinded treatment period of 24 weeks) and in the post treatment safety follow-up (Period 4)
|
VAY736 - 150 mg 28 Weeks (Periods 3 and 4)
n=47 participants at risk
All events reported from start of VAY736 - 150 mg dose in Period 3 (extended blinded treatment period of 28 weeks) up to the end of post treatment safety follow-up (Period 4)
|
VAY736 - 300 mg 24 Weeks (Entire Study)
n=26 participants at risk
All events reported from the beginning of the study up until the end of post treatment safety follow-up (Period 4)
|
VAY736 - 300 mg 52 Weeks (Entire Study)
n=21 participants at risk
All events reported from the beginning of the study up until the end of post treatment safety follow-up (Period 4)
|
Any VAY736 - 300 mg (Periods 2, 3 and 4)
n=47 participants at risk
All events reported from the beginning of the study up until the end of post treatment safety follow-up (Period 4)
|
Any VAY736 (Periods 2, 3 and 4)
n=188 participants at risk
All events reported from the beginning of the study up until the end of post treatment safety follow-up (Period 4)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.71%
1/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Pancreatic disorder
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.71%
1/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Immune system disorders
Cell-mediated immune deficiency
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.71%
1/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
COVID-19
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Candida infection
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.8%
1/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.71%
1/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Wound infection
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.8%
1/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Investigations
Weight decreased
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Nervous system disorders
Migraine
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.8%
1/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Nervous system disorders
Seizure
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Nervous system disorders
Syncope
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Product Issues
Device breakage
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
Other adverse events
| Measure |
Placebo (Up to Week 24)
n=49 participants at risk
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg (Up to Week 24)
n=47 participants at risk
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 50 mg (Up to Week 24)
n=47 participants at risk
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 300 mg (Up to Week 24)
n=47 participants at risk
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
Any VAY736 (Up to Week 24)
n=141 participants at risk
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
ALL (Up to Week 24)
n=190 participants at risk
Period 2 (Double blind Placebo s.c. administration every 4 weeks (q4w) for a 24-week period)
|
VAY736 - 5 mg 24 Weeks (Periods 2 and 4)
n=47 participants at risk
All events reported from start of VAY736 - 5 mg dose in Period 2 (blinded treatment period of 24 weeks) and in the post treatment safety follow-up (Period 4)
|
VAY736 - 50 mg 24 Weeks (Periods 2 and 4)
n=47 participants at risk
All events reported from start of VAY736 - 50 mg dose in Period 2 (blinded treatment period of 24 weeks) and in the post treatment safety follow-up (Period 4)
|
VAY736 - 150 mg 28 Weeks (Periods 3 and 4)
n=47 participants at risk
All events reported from start of VAY736 - 150 mg dose in Period 3 (extended blinded treatment period of 28 weeks) up to the end of post treatment safety follow-up (Period 4)
|
VAY736 - 300 mg 24 Weeks (Entire Study)
n=26 participants at risk
All events reported from the beginning of the study up until the end of post treatment safety follow-up (Period 4)
|
VAY736 - 300 mg 52 Weeks (Entire Study)
n=21 participants at risk
All events reported from the beginning of the study up until the end of post treatment safety follow-up (Period 4)
|
Any VAY736 - 300 mg (Periods 2, 3 and 4)
n=47 participants at risk
All events reported from the beginning of the study up until the end of post treatment safety follow-up (Period 4)
|
Any VAY736 (Periods 2, 3 and 4)
n=188 participants at risk
All events reported from the beginning of the study up until the end of post treatment safety follow-up (Period 4)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.71%
1/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
4/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.1%
2/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
12.8%
6/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.8%
11/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.8%
13/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
19.0%
4/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
12.8%
6/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.0%
15/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.1%
3/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.7%
8/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.8%
11/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.8%
1/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.9%
13/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.7%
8/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.7%
9/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.6%
5/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
12/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.4%
2/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.6%
3/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.7%
5/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
4/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.2%
4/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.7%
8/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.3%
12/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
11.5%
3/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
19.0%
4/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
14.9%
7/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.0%
15/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.4%
2/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.6%
3/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.5%
5/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.2%
6/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.8%
1/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.2%
6/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.4%
2/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.6%
3/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.6%
3/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
4/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
4/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.7%
5/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
General disorders
Asthenia
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.71%
1/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
General disorders
Influenza like illness
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
4/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.6%
5/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.8%
9/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
General disorders
Injection site reaction
|
4.1%
2/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
19.1%
9/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
55.3%
26/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
27.7%
39/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
21.6%
41/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
19.1%
9/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
36.2%
17/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
50.0%
13/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
66.7%
14/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
57.4%
27/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
30.3%
57/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
General disorders
Oedema peripheral
|
4.1%
2/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
4/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.2%
6/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.8%
1/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.7%
5/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
General disorders
Pyrexia
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.4%
2/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.6%
3/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
11.5%
3/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.7%
7/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.4%
2/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.8%
1/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.2%
6/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Bronchitis
|
4.1%
2/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.0%
7/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.7%
9/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.4%
14/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Conjunctivitis
|
6.1%
3/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.0%
7/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.3%
10/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.6%
5/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
12/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Cystitis
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
3/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.6%
3/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.8%
1/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.2%
6/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
3/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.6%
3/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.8%
1/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.7%
7/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Influenza
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
14.3%
3/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.7%
5/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
5/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
14.9%
7/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.2%
13/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
18/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
14.9%
7/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
23.4%
11/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
19.2%
5/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
19.0%
4/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
19.1%
9/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
16.5%
31/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.8%
1/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
4/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Oral herpes
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
4/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.6%
5/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
14.3%
3/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
12/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Parotitis
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.4%
2/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.2%
6/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Sinusitis
|
8.2%
4/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
6/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.3%
10/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.6%
5/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
14.9%
7/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.8%
1/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.6%
18/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
4/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
4/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
4/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.2%
4/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.6%
5/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.8%
11/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.9%
15/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
14.9%
7/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
19.1%
9/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
14.9%
7/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
30.8%
8/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
21.3%
10/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
17.6%
33/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Urinary tract infection
|
8.2%
4/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
12.8%
6/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.7%
8/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.3%
12/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
19.1%
9/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.6%
5/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
14.9%
7/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
14.3%
3/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.6%
5/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
13.8%
26/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
3/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.6%
3/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
4/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.6%
3/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.4%
2/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.7%
5/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.71%
1/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.7%
5/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
4.1%
2/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
12.8%
6/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.6%
5/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.6%
15/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.9%
17/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
12.8%
6/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.6%
5/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
14.9%
7/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
11.7%
22/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Injury, poisoning and procedural complications
Wound
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.6%
3/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Investigations
Blood creatinine increased
|
4.1%
2/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
3/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.6%
5/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.2%
6/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
4/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
4/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.7%
7/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
3/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.6%
3/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.8%
1/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.2%
6/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Investigations
White blood cell count decreased
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.5%
5/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.2%
6/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.8%
1/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.2%
6/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.2%
5/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.5%
5/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.3%
10/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
12.8%
6/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
14.3%
3/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.6%
5/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.0%
15/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
3/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.0%
7/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.3%
10/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
12.8%
6/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
15.4%
4/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
12.8%
6/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.1%
19/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
3/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
4/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.8%
1/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.7%
5/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.4%
2/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
4/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
3/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
4/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
1/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.8%
9/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
4/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
4/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.9%
11/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.7%
7/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
4/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
4/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.7%
7/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Nervous system disorders
Headache
|
14.3%
7/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
12/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.0%
19/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.6%
5/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.6%
5/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
15.4%
4/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
12.8%
6/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.6%
20/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.71%
1/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.4%
2/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.6%
3/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
14.3%
3/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.2%
6/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.71%
1/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.53%
1/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.6%
3/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
4/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.6%
5/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.7%
7/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.6%
3/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.71%
1/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.6%
3/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
4/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.6%
5/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.8%
1/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
8/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.1%
3/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.0%
7/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.3%
10/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
12.8%
6/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
3/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.7%
2/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.5%
2/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.0%
15/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Vascular disorders
Hypertension
|
0.00%
0/49 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
1/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
3/141 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.6%
3/190 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.5%
4/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
2/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/26 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/21 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/47 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
8/188 • From first dose of study drug until end of follow-up period, up to approximately 3 years (max duration of follow-up was 2 years).
An adverse event is any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
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