Trial Outcomes & Findings for Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome (NCT NCT02291029)
NCT ID: NCT02291029
Last Updated: 2021-01-05
Results Overview
The effect of CFZ533 on clinical disease activity was measured by the change in ESSDAI (EULAR Sjögren's syndrome disease activity index) between baseline and week 12. The instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score (range 0-123). A reduction from baseline indicates improvement in patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2021-01-05
Participant Flow
A total of 69 patients were enrolled in Germany (1 center), Hungary (1 center), Switzerland (1 center), United Kingdom (3 centers), United States (3 centers)
Participant milestones
| Measure |
Cohort 1 CFZ533
CFZ533 3 mg/kg s.c.
|
Cohort 1 Placebo
Placebo s.c./CFZ533 3 mg/kg s.c.
|
Cohort 2 CFZ533
CFZ533 10 mg/kg i.v.
|
Cohort 2 Placebo
Placebo i.v./CFZ533 10 mg/kg i.v.
|
Cohort 3 CFZ533 Arm 1
CFZ533 600 mg s.c./CFZ533 300 mg s.c.
|
Cohort 3 CFZ533 Arm 2
CFZ533 10 mg/kg i.v./CFZ533 300 mg s.c.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
4
|
21
|
11
|
13
|
12
|
|
Overall Study
COMPLETED
|
8
|
3
|
20
|
11
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 CFZ533
CFZ533 3 mg/kg s.c.
|
Cohort 1 Placebo
Placebo s.c./CFZ533 3 mg/kg s.c.
|
Cohort 2 CFZ533
CFZ533 10 mg/kg i.v.
|
Cohort 2 Placebo
Placebo i.v./CFZ533 10 mg/kg i.v.
|
Cohort 3 CFZ533 Arm 1
CFZ533 600 mg s.c./CFZ533 300 mg s.c.
|
Cohort 3 CFZ533 Arm 2
CFZ533 10 mg/kg i.v./CFZ533 300 mg s.c.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome
Baseline characteristics by cohort
| Measure |
Cohort 1 CFZ533
n=8 Participants
CFZ533 3 mg/kg s.c.
|
Cohort 1 Placebo
n=4 Participants
Placebo s.c./CFZ533 3 mg/kg s.c.
|
Cohort 2 CFZ533
n=21 Participants
CFZ533 10 mg/kg i.v.
|
Cohort 2 Placebo
n=11 Participants
Placebo i.v./CFZ533 10 mg/kg i.v.
|
Cohort 3 CFZ533 Arm 1
n=13 Participants
CFZ533 600 mg s.c./CFZ533 300 mg s.c.
|
Cohort 3 CFZ533 Arm 2
n=12 Participants
CFZ533 10 mg/kg i.v./CFZ533 300 mg s.c.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.4 years
n=5 Participants
|
48.8 years
n=7 Participants
|
51.7 years
n=5 Participants
|
50.6 years
n=4 Participants
|
52.3 years
n=21 Participants
|
54.8 years
n=10 Participants
|
52.6 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
64 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
61 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: PD Population (all subjects with available Pharmacodynamics data and no protocol deviations with relevant impact on PD data)
The effect of CFZ533 on clinical disease activity was measured by the change in ESSDAI (EULAR Sjögren's syndrome disease activity index) between baseline and week 12. The instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score (range 0-123). A reduction from baseline indicates improvement in patients.
Outcome measures
| Measure |
Cohort 1 CFZ533
n=8 Participants
CFZ533 3 mg/kg s.c.
|
Cohort 1 Placebo
n=4 Participants
Placebo s.c./CFZ533 3 mg/kg s.c.
|
Cohort 2 CFZ533
n=21 Participants
CFZ533 10 mg/kg i.v.
|
Cohort 2 Placebo
n=11 Participants
Placebo i.v./CFZ533 10 mg/kg i.v.
|
Cohort 3 CFZ533 Arm 1
n=13 Participants
CFZ533 600 mg s.c./CFZ533 300 mg s.c.
|
Cohort 3 CFZ533 Arm 2
n=12 Participants
CFZ533 10 mg/kg i.v./CFZ533 300 mg s.c.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
Baseline
|
12.0 units on a scale
Standard Deviation 3.78
|
11.8 units on a scale
Standard Deviation 3.86
|
10.6 units on a scale
Standard Deviation 4.44
|
11.0 units on a scale
Standard Deviation 5.16
|
12.7 units on a scale
Standard Deviation 6.06
|
10.4 units on a scale
Standard Deviation 5.87
|
|
Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
Week 12
|
9.6 units on a scale
Standard Deviation 5.45
|
9.8 units on a scale
Standard Deviation 3.30
|
4.2 units on a scale
Standard Deviation 4.25
|
9.7 units on a scale
Standard Deviation 9.05
|
7.2 units on a scale
Standard Deviation 6.69
|
2.8 units on a scale
Standard Deviation 2.48
|
|
Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
Change from Baseline to Week 12
|
-2.4 units on a scale
Standard Deviation 2.77
|
-2.0 units on a scale
Standard Deviation 2.45
|
-6.4 units on a scale
Standard Deviation 4.00
|
-1.3 units on a scale
Standard Deviation 8.06
|
-5.5 units on a scale
Standard Deviation 5.49
|
-7.6 units on a scale
Standard Deviation 7.14
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: PD Population
The ESSPRI is a patient self-reported outcome measure to assess dryness, limb pain, fatigue and mental fatigue, where each of the domains normally reported as 0 (not at all) to 10 (extremely severe). The final ESSPRI score is the average of three: dryness, pain and fatigue. A reduction from baseline indicates the improvement of symptoms.
Outcome measures
| Measure |
Cohort 1 CFZ533
n=8 Participants
CFZ533 3 mg/kg s.c.
|
Cohort 1 Placebo
n=4 Participants
Placebo s.c./CFZ533 3 mg/kg s.c.
|
Cohort 2 CFZ533
n=21 Participants
CFZ533 10 mg/kg i.v.
|
Cohort 2 Placebo
n=11 Participants
Placebo i.v./CFZ533 10 mg/kg i.v.
|
Cohort 3 CFZ533 Arm 1
n=13 Participants
CFZ533 600 mg s.c./CFZ533 300 mg s.c.
|
Cohort 3 CFZ533 Arm 2
n=12 Participants
CFZ533 10 mg/kg i.v./CFZ533 300 mg s.c.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI)
Baseline
|
6.75 units on a scale
Standard Deviation 1.909
|
7.00 units on a scale
Standard Deviation 1.826
|
6.71 units on a scale
Standard Deviation 1.678
|
7.18 units on a scale
Standard Deviation 1.486
|
7.00 units on a scale
Standard Deviation 1.604
|
6.00 units on a scale
Standard Deviation 2.344
|
|
Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI)
Week 12
|
5.71 units on a scale
Standard Deviation 1.240
|
7.08 units on a scale
Standard Deviation 2.251
|
5.03 units on a scale
Standard Deviation 2.413
|
6.24 units on a scale
Standard Deviation 2.039
|
5.33 units on a scale
Standard Deviation 2.269
|
4.83 units on a scale
Standard Deviation 2.552
|
|
Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI)
Change from Baseline to Week 12
|
-1.04 units on a scale
Standard Deviation 1.201
|
0.08 units on a scale
Standard Deviation 0.631
|
-1.68 units on a scale
Standard Deviation 1.954
|
-0.94 units on a scale
Standard Deviation 1.246
|
-1.67 units on a scale
Standard Deviation 1.841
|
-1.17 units on a scale
Standard Deviation 2.333
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: PD Population (Statistical Analysis only for Cohort 1 and 2)
The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).
Outcome measures
| Measure |
Cohort 1 CFZ533
n=8 Participants
CFZ533 3 mg/kg s.c.
|
Cohort 1 Placebo
n=4 Participants
Placebo s.c./CFZ533 3 mg/kg s.c.
|
Cohort 2 CFZ533
n=21 Participants
CFZ533 10 mg/kg i.v.
|
Cohort 2 Placebo
n=11 Participants
Placebo i.v./CFZ533 10 mg/kg i.v.
|
Cohort 3 CFZ533 Arm 1
n=13 Participants
CFZ533 600 mg s.c./CFZ533 300 mg s.c.
|
Cohort 3 CFZ533 Arm 2
n=12 Participants
CFZ533 10 mg/kg i.v./CFZ533 300 mg s.c.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (VAS)
Baseline
|
57.9 units on a scale
Standard Deviation 15.72
|
57.8 units on a scale
Standard Deviation 17.19
|
51.9 units on a scale
Standard Deviation 12.62
|
47.9 units on a scale
Standard Deviation 19.18
|
50.4 units on a scale
Standard Deviation 12.39
|
47.1 units on a scale
Standard Deviation 18.34
|
|
Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (VAS)
Week 12
|
40.5 units on a scale
Standard Deviation 16.42
|
55.5 units on a scale
Standard Deviation 12.01
|
22.8 units on a scale
Standard Deviation 11.78
|
34.2 units on a scale
Standard Deviation 13.90
|
25.4 units on a scale
Standard Deviation 16.65
|
27.3 units on a scale
Standard Deviation 16.74
|
|
Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (VAS)
Change from Baseline to Week 12
|
-17.6 units on a scale
Standard Deviation 24.60
|
-2.3 units on a scale
Standard Deviation 10.90
|
-28.7 units on a scale
Standard Deviation 16.02
|
-13.7 units on a scale
Standard Deviation 22.97
|
-25.0 units on a scale
Standard Deviation 15.30
|
-19.8 units on a scale
Standard Deviation 21.96
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: PD Population (Statistical Analysis only for Cohort 1 and 2)
The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).
Outcome measures
| Measure |
Cohort 1 CFZ533
n=8 Participants
CFZ533 3 mg/kg s.c.
|
Cohort 1 Placebo
n=4 Participants
Placebo s.c./CFZ533 3 mg/kg s.c.
|
Cohort 2 CFZ533
n=21 Participants
CFZ533 10 mg/kg i.v.
|
Cohort 2 Placebo
n=11 Participants
Placebo i.v./CFZ533 10 mg/kg i.v.
|
Cohort 3 CFZ533 Arm 1
n=13 Participants
CFZ533 600 mg s.c./CFZ533 300 mg s.c.
|
Cohort 3 CFZ533 Arm 2
n=12 Participants
CFZ533 10 mg/kg i.v./CFZ533 300 mg s.c.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS)
Baseline
|
47.13 units on a scale
Standard Deviation 32.406
|
73.00 units on a scale
Standard Deviation 12.623
|
58.43 units on a scale
Standard Deviation 19.881
|
54.91 units on a scale
Standard Deviation 21.002
|
63.69 units on a scale
Standard Deviation 25.799
|
52.08 units on a scale
Standard Deviation 22.138
|
|
Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS)
Week 12
|
49.06 units on a scale
Standard Deviation 24.519
|
75.50 units on a scale
Standard Deviation 24.393
|
34.85 units on a scale
Standard Deviation 24.564
|
42.27 units on a scale
Standard Deviation 24.483
|
38.46 units on a scale
Standard Deviation 26.965
|
53.17 units on a scale
Standard Deviation 25.305
|
|
Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS)
Change from Baseline to Week 12
|
1.94 units on a scale
Standard Deviation 26.023
|
2.50 units on a scale
Standard Deviation 17.861
|
-23.05 units on a scale
Standard Deviation 26.920
|
-12.64 units on a scale
Standard Deviation 26.871
|
-25.23 units on a scale
Standard Deviation 29.833
|
1.08 units on a scale
Standard Deviation 23.283
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: PD Population for Cohort 1 and Cohort 2. Data were not collected from participants in Cohort 3 CFZ533 Arm 1 and Cohort 3 CFZ533 Arm 2.
The SF-36 is a 36-item, patient self-reported outcome measure (questionnaires) of patient health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. An increase from baseline in either component summary score indicates reduced disease burden.
Outcome measures
| Measure |
Cohort 1 CFZ533
n=8 Participants
CFZ533 3 mg/kg s.c.
|
Cohort 1 Placebo
n=4 Participants
Placebo s.c./CFZ533 3 mg/kg s.c.
|
Cohort 2 CFZ533
n=21 Participants
CFZ533 10 mg/kg i.v.
|
Cohort 2 Placebo
n=11 Participants
Placebo i.v./CFZ533 10 mg/kg i.v.
|
Cohort 3 CFZ533 Arm 1
CFZ533 600 mg s.c./CFZ533 300 mg s.c.
|
Cohort 3 CFZ533 Arm 2
CFZ533 10 mg/kg i.v./CFZ533 300 mg s.c.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form (36) Health Survey (SF-36) Physical Component Score
Baseline
|
42.218 units on a scale
Standard Deviation 6.9437
|
31.215 units on a scale
Standard Deviation 12.5562
|
38.163 units on a scale
Standard Deviation 8.5905
|
38.819 units on a scale
Standard Deviation 5.9689
|
—
|
—
|
|
Change From Baseline in Short Form (36) Health Survey (SF-36) Physical Component Score
Week 12
|
40.374 units on a scale
Standard Deviation 9.2230
|
36.123 units on a scale
Standard Deviation 13.0002
|
44.001 units on a scale
Standard Deviation 9.3943
|
40.298 units on a scale
Standard Deviation 8.9392
|
—
|
—
|
|
Change From Baseline in Short Form (36) Health Survey (SF-36) Physical Component Score
Change from Baseline to Week 12
|
-1.005 units on a scale
Standard Deviation 4.5380
|
4.908 units on a scale
Standard Deviation 4.2349
|
5.546 units on a scale
Standard Deviation 7.1760
|
1.479 units on a scale
Standard Deviation 8.2497
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: PD Population for Cohort 1 and Cohort 2. Data were not collected from participants in Cohort 3 CFZ533 Arm 1 and Cohort 3 CFZ533 Arm 2.
The SF-36 is a 36-item, patient self-reported outcome measure (questionnaires) of patient health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. An increase from baseline in either component summary score indicates reduced disease burden.
Outcome measures
| Measure |
Cohort 1 CFZ533
n=8 Participants
CFZ533 3 mg/kg s.c.
|
Cohort 1 Placebo
n=4 Participants
Placebo s.c./CFZ533 3 mg/kg s.c.
|
Cohort 2 CFZ533
n=21 Participants
CFZ533 10 mg/kg i.v.
|
Cohort 2 Placebo
n=11 Participants
Placebo i.v./CFZ533 10 mg/kg i.v.
|
Cohort 3 CFZ533 Arm 1
CFZ533 600 mg s.c./CFZ533 300 mg s.c.
|
Cohort 3 CFZ533 Arm 2
CFZ533 10 mg/kg i.v./CFZ533 300 mg s.c.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form (36) Health Survey (SF-36) Mental Component Score
Week 12
|
48.076 units on a scale
Standard Deviation 12.5197
|
43.660 units on a scale
Standard Deviation 13.9997
|
44.688 units on a scale
Standard Deviation 10.2469
|
43.785 units on a scale
Standard Deviation 13.2982
|
—
|
—
|
|
Change From Baseline in Short Form (36) Health Survey (SF-36) Mental Component Score
Change from Baseline to Week 12
|
0.373 units on a scale
Standard Deviation 6.3174
|
0.543 units on a scale
Standard Deviation 4.0309
|
8.212 units on a scale
Standard Deviation 11.1378
|
4.273 units on a scale
Standard Deviation 10.7671
|
—
|
—
|
|
Change From Baseline in Short Form (36) Health Survey (SF-36) Mental Component Score
Baseline
|
46.838 units on a scale
Standard Deviation 7.8986
|
43.118 units on a scale
Standard Deviation 16.3701
|
37.071 units on a scale
Standard Deviation 12.2914
|
39.512 units on a scale
Standard Deviation 15.4212
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: PD Population for Cohort 1 and Cohort 2. Data were not collected from participants in Cohort 3 CFZ533 Arm 1 and Cohort 3 CFZ533 Arm 2.
The MFI is a patient self-reported outcome measure (questionnaires) to assess fatigue covering the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each dimension has a possible range from 4-20. The reported total score has a range from 20-100. A reduction from baseline in MFI indicates improvement.
Outcome measures
| Measure |
Cohort 1 CFZ533
n=8 Participants
CFZ533 3 mg/kg s.c.
|
Cohort 1 Placebo
n=4 Participants
Placebo s.c./CFZ533 3 mg/kg s.c.
|
Cohort 2 CFZ533
n=21 Participants
CFZ533 10 mg/kg i.v.
|
Cohort 2 Placebo
n=11 Participants
Placebo i.v./CFZ533 10 mg/kg i.v.
|
Cohort 3 CFZ533 Arm 1
CFZ533 600 mg s.c./CFZ533 300 mg s.c.
|
Cohort 3 CFZ533 Arm 2
CFZ533 10 mg/kg i.v./CFZ533 300 mg s.c.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Multidimensional Fatigue Inventory (MFI)
Baseline
|
54.1 units on a scale
Standard Deviation 16.23
|
78.0 units on a scale
Standard Deviation 17.80
|
70.0 units on a scale
Standard Deviation 17.51
|
66.2 units on a scale
Standard Deviation 17.59
|
—
|
—
|
|
Change From Baseline in Multidimensional Fatigue Inventory (MFI)
Change from Baseline to Week 12
|
-0.6 units on a scale
Standard Deviation 8.12
|
-8.3 units on a scale
Standard Deviation 8.18
|
-14.5 units on a scale
Standard Deviation 18.09
|
-2.9 units on a scale
Standard Deviation 12.37
|
—
|
—
|
|
Change From Baseline in Multidimensional Fatigue Inventory (MFI)
Week 12
|
53.5 units on a scale
Standard Deviation 13.96
|
69.8 units on a scale
Standard Deviation 17.75
|
55.2 units on a scale
Standard Deviation 16.65
|
63.3 units on a scale
Standard Deviation 16.99
|
—
|
—
|
Adverse Events
Cohort 1 CFZ533
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 1 Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2 CFZ533
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 2 Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 3 CFZ533 Arm 1
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 3 CFZ533 Arm 2
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 CFZ533
n=8 participants at risk
CFZ533 3 mg/kg s.c.
|
Cohort 1 Placebo
n=4 participants at risk
Placebo s.c./CFZ533 3 mg/kg s.c.
|
Cohort 2 CFZ533
n=21 participants at risk
CFZ533 10 mg/kg i.v.
|
Cohort 2 Placebo
n=11 participants at risk
Placebo i.v./CFZ533 10 mg/kg i.v.
|
Cohort 3 CFZ533 Arm 1
n=13 participants at risk
CFZ533 600 mg s.c./CFZ533 300 mg s.c.
|
Cohort 3 CFZ533 Arm 2
n=12 participants at risk
CFZ533 10 mg/kg i.v./CFZ533 300 mg s.c.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Conjunctivitis bacterial
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
Other adverse events
| Measure |
Cohort 1 CFZ533
n=8 participants at risk
CFZ533 3 mg/kg s.c.
|
Cohort 1 Placebo
n=4 participants at risk
Placebo s.c./CFZ533 3 mg/kg s.c.
|
Cohort 2 CFZ533
n=21 participants at risk
CFZ533 10 mg/kg i.v.
|
Cohort 2 Placebo
n=11 participants at risk
Placebo i.v./CFZ533 10 mg/kg i.v.
|
Cohort 3 CFZ533 Arm 1
n=13 participants at risk
CFZ533 600 mg s.c./CFZ533 300 mg s.c.
|
Cohort 3 CFZ533 Arm 2
n=12 participants at risk
CFZ533 10 mg/kg i.v./CFZ533 300 mg s.c.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.5%
2/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
General disorders
Cyst
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Injury, poisoning and procedural complications
Incision site hypoaesthesia
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Ear and labyrinth disorders
Cerumen impaction
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Ear and labyrinth disorders
Hypoacusis
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Eye disorders
Blepharitis
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Eye disorders
Cataract
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Eye disorders
Diplopia
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Eye disorders
Dry eye
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Eye disorders
Eye pain
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Eye disorders
Ocular hyperaemia
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
16.7%
2/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.5%
2/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
16.7%
2/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Gastrointestinal disorders
Tongue ulceration
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Gastrointestinal disorders
Toothache
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
General disorders
Chills
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
General disorders
Fatigue
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
General disorders
Inflammation
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
General disorders
Injection site bruising
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
General disorders
Injection site erythema
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
General disorders
Injection site haematoma
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
15.4%
2/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
General disorders
Injection site reaction
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
General disorders
Nodule
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
General disorders
Peripheral swelling
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Immune system disorders
Seasonal allergy
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Body tinea
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
16.7%
2/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Candida infection
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Conjunctivitis
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Cystitis
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Ear infection
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Gingivitis
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Localised infection
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Lower respiratory tract infection
|
25.0%
2/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Lymph gland infection
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Nail bed infection
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
18.2%
2/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
33.3%
4/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
16.7%
2/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Otitis media
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Paronychia
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Rhinitis
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Skin infection
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
2/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
50.0%
2/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.5%
2/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
18.2%
2/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
30.8%
4/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
16.7%
2/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Urinary tract infection
|
25.0%
2/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
16.7%
2/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Urogenital infection bacterial
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Investigations
Blood pressure increased
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Investigations
Body temperature increased
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Investigations
C-reactive protein increased
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Investigations
Lipase increased
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
18.2%
2/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Investigations
Red blood cells urine positive
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Investigations
White blood cell count decreased
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Investigations
White blood cells urine positive
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Metabolism and nutrition disorders
Appetite disorder
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
2/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
16.7%
2/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal wall neoplasm
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Nervous system disorders
Amnesia
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.5%
2/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
15.4%
2/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
33.3%
4/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Nervous system disorders
Hemianopia homonymous
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Psychiatric disorders
Depressed mood
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Reproductive system and breast disorders
Amenorrhoea
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Reproductive system and breast disorders
Endometrial disorder
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Reproductive system and breast disorders
Uterine pain
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Reproductive system and breast disorders
Uterine prolapse
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
7.7%
1/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
2/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
25.0%
1/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
9.1%
1/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
12.5%
1/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
4.8%
1/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/4 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/21 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/11 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
0.00%
0/13 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
8.3%
1/12 • Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion)
|
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