Trial Outcomes & Findings for Biomarkers of Exposure and Biomarkers of Potential Harm in Adult Smokers Who Completely Switch to E-vapor Products (NCT NCT04800211)
NCT ID: NCT04800211
Last Updated: 2025-03-12
Results Overview
Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (ng/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV). Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3 The first urine void of the day was collected at Visits 3, 5 and 7. Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration values as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline = Post Product Use Value - Baseline Value
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
450 participants
Primary outcome timeframe
12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Results posted on
2025-03-12
Participant Flow
After screening, subjects who met all eligibility criteria were randomized to one of the study groups. Eligible subjects who completed ALCS-RA-16-06-EV were entered into the ALCS-RA-17-11-EV 12-week extension study and assigned to the same study groups as the ALCS-RA-16-06-EV study.
Participant milestones
| Measure |
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|
|
ALCS-RA-16-06-EV (Weeks 1-12)
STARTED
|
151
|
150
|
149
|
|
ALCS-RA-16-06-EV (Weeks 1-12)
COMPLETED
|
121
|
125
|
136
|
|
ALCS-RA-16-06-EV (Weeks 1-12)
NOT COMPLETED
|
30
|
25
|
13
|
|
ALCS-RA-17-11-EV (Weeks 12-24)
STARTED
|
48
|
50
|
52
|
|
ALCS-RA-17-11-EV (Weeks 12-24)
COMPLETED
|
47
|
50
|
49
|
|
ALCS-RA-17-11-EV (Weeks 12-24)
NOT COMPLETED
|
1
|
0
|
3
|
Reasons for withdrawal
| Measure |
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|
|
ALCS-RA-16-06-EV (Weeks 1-12)
Adverse Event
|
4
|
1
|
0
|
|
ALCS-RA-16-06-EV (Weeks 1-12)
Failure To Meet Ie Post Enrollment
|
1
|
0
|
0
|
|
ALCS-RA-16-06-EV (Weeks 1-12)
Lost to Follow-up
|
8
|
8
|
2
|
|
ALCS-RA-16-06-EV (Weeks 1-12)
Non-Compliance With Study Procedures
|
8
|
7
|
2
|
|
ALCS-RA-16-06-EV (Weeks 1-12)
Other
|
1
|
2
|
2
|
|
ALCS-RA-16-06-EV (Weeks 1-12)
Physician Decision
|
0
|
0
|
1
|
|
ALCS-RA-16-06-EV (Weeks 1-12)
Pregnancy
|
0
|
0
|
1
|
|
ALCS-RA-16-06-EV (Weeks 1-12)
Withdrawal by Subject
|
8
|
7
|
5
|
|
ALCS-RA-17-11-EV (Weeks 12-24)
Non-Compliance With Study Procedures
|
0
|
0
|
1
|
|
ALCS-RA-17-11-EV (Weeks 12-24)
Other
|
0
|
0
|
2
|
|
ALCS-RA-17-11-EV (Weeks 12-24)
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Biomarkers of Exposure and Biomarkers of Potential Harm in Adult Smokers Who Completely Switch to E-vapor Products
Baseline characteristics by cohort
| Measure |
Test 1
n=151 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=150 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Control
n=149 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
Total
n=450 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 8.45 • n=99 Participants
|
44.1 years
STANDARD_DEVIATION 9.26 • n=107 Participants
|
44.4 years
STANDARD_DEVIATION 10.1 • n=206 Participants
|
44.1 years
STANDARD_DEVIATION 9.24 • n=7 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
222 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
228 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
143 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
145 Participants
n=206 Participants
|
430 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
44 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
119 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
103 Participants
n=99 Participants
|
111 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
320 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Annual Income
I DO NOT WISH TO ANSWER
|
13 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Annual Income
UNDER $20,000
|
37 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
129 Participants
n=7 Participants
|
|
Annual Income
$20,000 - $29,999
|
39 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
89 Participants
n=7 Participants
|
|
Annual Income
$30,000 - $39,999
|
25 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
|
Annual Income
$40,000 - $49,999
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Annual Income
$50,000 - $59,999
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
|
Annual Income
$60,000 - $74,999
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Annual Income
$75,000 - $99,000
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Annual Income
$100,000 - $149,999
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Annual Income
$150,000 AND OVER
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Highest Degree
I DO NOT WISH TO ANSWER
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Highest Degree
GRADES 1 THROUGH 8 (ELEMENTARY)
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Highest Degree
GRADES 9 THROUGH 11 (SOME HIGH SCHOOL)
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Highest Degree
GRADE 12 OR GED (HIGH SCHOOL GRADUATE)
|
61 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
166 Participants
n=7 Participants
|
|
Highest Degree
COLLEGE 1 YEAR TO 3 YEARS (SOME COLLEGE
|
69 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
191 Participants
n=7 Participants
|
|
Highest Degree
COLLEGE 4 YEARS OR MORE (COLLEGE GRADUATE
|
12 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
|
Highest Degree
POSTGRADUATE/MASTERS/DOCTORATE/LAW/MD
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Highest Degree
OTHER
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Weight
|
82.0 kilograms
STANDARD_DEVIATION 17.43 • n=99 Participants
|
82.2 kilograms
STANDARD_DEVIATION 17.63 • n=107 Participants
|
81.1 kilograms
STANDARD_DEVIATION 15.90 • n=206 Participants
|
81.8 kilograms
STANDARD_DEVIATION 16.98 • n=7 Participants
|
|
Body Mass Index
|
27.810 (kg/m²)
STANDARD_DEVIATION 5.1312 • n=99 Participants
|
27.915 (kg/m²)
STANDARD_DEVIATION 5.1466 • n=107 Participants
|
27.733 (kg/m²)
STANDARD_DEVIATION 4.9777 • n=206 Participants
|
27.820 (kg/m²)
STANDARD_DEVIATION 5.0753 • n=7 Participants
|
|
Daily Cigarette Use
|
18.2 Cigarettes per day
STANDARD_DEVIATION 5.71 • n=99 Participants
|
17.0 Cigarettes per day
STANDARD_DEVIATION 5.23 • n=107 Participants
|
17.4 Cigarettes per day
STANDARD_DEVIATION 5.79 • n=206 Participants
|
17.5 Cigarettes per day
STANDARD_DEVIATION 5.59 • n=7 Participants
|
|
Years Smoked
|
24.1 years
STANDARD_DEVIATION 8.32 • n=99 Participants
|
25.0 years
STANDARD_DEVIATION 9.48 • n=107 Participants
|
24.5 years
STANDARD_DEVIATION 9.78 • n=206 Participants
|
24.5 years
STANDARD_DEVIATION 9.20 • n=7 Participants
|
|
Height
|
171.51 cm
STANDARD_DEVIATION 9.402 • n=99 Participants
|
171.40 cm
STANDARD_DEVIATION 9.682 • n=107 Participants
|
171.00 cm
STANDARD_DEVIATION 9.651 • n=206 Participants
|
171.31 cm
STANDARD_DEVIATION 9.560 • n=7 Participants
|
PRIMARY outcome
Timeframe: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12Population: Modified Intention-to-Treat (mITT): All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (ng/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV). Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3 The first urine void of the day was collected at Visits 3, 5 and 7. Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration values as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline = Post Product Use Value - Baseline Value
Outcome measures
| Measure |
Test 1
n=127 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=131 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=258 Participants
Combined e-Vapor Use Group
|
Control
n=138 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 3 (Baseline): Week 1
|
309.098 ng/g
Standard Deviation 253.5221
|
294.831 ng/g
Standard Deviation 212.1778
|
301.854 ng/g
Standard Deviation 233.0988
|
311.851 ng/g
Standard Deviation 245.2203
|
|
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 5: Week 6
|
127.254 ng/g
Standard Deviation 191.0786
|
120.568 ng/g
Standard Deviation 157.7745
|
123.925 ng/g
Standard Deviation 174.9627
|
308.521 ng/g
Standard Deviation 220.7403
|
|
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 7: Week 12
|
101.544 ng/g
Standard Deviation 146.4668
|
124.000 ng/g
Standard Deviation 163.0721
|
113.159 ng/g
Standard Deviation 155.3513
|
300.819 ng/g
Standard Deviation 217.6292
|
|
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline (Week 6)
|
-180.390 ng/g
Standard Deviation 206.3278
|
-173.299 ng/g
Standard Deviation 186.8030
|
-176.859 ng/g
Standard Deviation 196.4791
|
-8.733 ng/g
Standard Deviation 140.9375
|
|
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline (Week 12)
|
-191.327 ng/g
Standard Deviation 220.6982
|
-160.201 ng/g
Standard Deviation 192.1456
|
-175.228 ng/g
Standard Deviation 206.5607
|
-15.898 ng/g
Standard Deviation 149.1447
|
PRIMARY outcome
Timeframe: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Summary of Urine Total NNAL (ng/g) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV). The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study. Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Change from Baseline was calculated as follows: Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Outcome measures
| Measure |
Test 1
n=47 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=50 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=97 Participants
Combined e-Vapor Use Group
|
Control
n=49 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Baseline: Week 1
|
258.644 ng/g
Standard Deviation 190.1771
|
294.309 ng/g
Standard Deviation 217.0554
|
277.028 ng/g
Standard Deviation 204.2020
|
368.502 ng/g
Standard Deviation 255.5299
|
|
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 1: Week 12
|
37.240 ng/g
Standard Deviation 74.0723
|
65.631 ng/g
Standard Deviation 105.4324
|
51.875 ng/g
Standard Deviation 92.2293
|
357.472 ng/g
Standard Deviation 261.5709
|
|
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 3: Week 18
|
34.715 ng/g
Standard Deviation 73.2359
|
56.986 ng/g
Standard Deviation 110.8673
|
46.863 ng/g
Standard Deviation 95.7548
|
294.906 ng/g
Standard Deviation 194.0554
|
|
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 5: Week 24
|
40.991 ng/g
Standard Deviation 80.9328
|
80.808 ng/g
Standard Deviation 174.5894
|
62.227 ng/g
Standard Deviation 139.6906
|
274.912 ng/g
Standard Deviation 186.7002
|
|
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 12)
|
-221.403 ng/g
Standard Deviation 177.5875
|
-228.678 ng/g
Standard Deviation 187.6797
|
-225.153 ng/g
Standard Deviation 181.9443
|
-11.030 ng/g
Standard Deviation 130.5603
|
|
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 18)
|
-222.851 ng/g
Standard Deviation 172.2263
|
-234.967 ng/g
Standard Deviation 198.3954
|
-229.460 ng/g
Standard Deviation 186.0037
|
-78.423 ng/g
Standard Deviation 149.1454
|
|
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 24)
|
-218.417 ng/g
Standard Deviation 171.7527
|
-215.432 ng/g
Standard Deviation 213.0743
|
-216.825 ng/g
Standard Deviation 193.8228
|
-85.075 ng/g
Standard Deviation 134.0116
|
PRIMARY outcome
Timeframe: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Summary of whole blood carboxyhemoglobin (COHb) (% Saturation) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV). Blood samples were collected via direct venipuncture at Visits 3, 5, and 7. Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Outcome measures
| Measure |
Test 1
n=127 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=131 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=258 Participants
Combined e-Vapor Use Group
|
Control
n=138 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 3 (Baseline): Week 1
|
5.63 percent saturation
Standard Deviation 2.073
|
5.39 percent saturation
Standard Deviation 1.868
|
5.51 percent saturation
Standard Deviation 1.971
|
5.61 percent saturation
Standard Deviation 1.957
|
|
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 5: Week 6
|
3.26 percent saturation
Standard Deviation 1.790
|
3.10 percent saturation
Standard Deviation 1.449
|
3.18 percent saturation
Standard Deviation 1.626
|
6.05 percent saturation
Standard Deviation 2.029
|
|
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 7: Week 12
|
2.99 percent saturation
Standard Deviation 1.550
|
2.92 percent saturation
Standard Deviation 1.141
|
2.95 percent saturation
Standard Deviation 1.351
|
5.68 percent saturation
Standard Deviation 1.986
|
|
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline (Week 6)
|
-2.34 percent saturation
Standard Deviation 2.278
|
-2.30 percent saturation
Standard Deviation 2.355
|
-2.32 percent saturation
Standard Deviation 2.313
|
0.40 percent saturation
Standard Deviation 1.813
|
|
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline (Week 12)
|
-2.49 percent saturation
Standard Deviation 2.498
|
-2.44 percent saturation
Standard Deviation 2.187
|
-2.46 percent saturation
Standard Deviation 2.337
|
0.07 percent saturation
Standard Deviation 1.920
|
PRIMARY outcome
Timeframe: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Summary of Whole Blood COHb (% Saturation) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV). Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study. Change from Baseline was calculated as follows: Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Outcome measures
| Measure |
Test 1
n=47 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=50 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=97 Participants
Combined e-Vapor Use Group
|
Control
n=48 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Baseline: Week 1
|
5.36 percent saturation
Standard Deviation 2.096
|
5.27 percent saturation
Standard Deviation 1.572
|
5.31 percent saturation
Standard Deviation 1.835
|
5.60 percent saturation
Standard Deviation 1.607
|
|
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 1: Week 12
|
2.28 percent saturation
Standard Deviation 0.786
|
2.52 percent saturation
Standard Deviation 0.796
|
2.40 percent saturation
Standard Deviation 0.796
|
6.34 percent saturation
Standard Deviation 2.052
|
|
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 3: Week 18
|
2.61 percent saturation
Standard Deviation 0.759
|
2.92 percent saturation
Standard Deviation 0.944
|
2.78 percent saturation
Standard Deviation 0.876
|
6.74 percent saturation
Standard Deviation 1.971
|
|
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 5: Week 24
|
2.17 percent saturation
Standard Deviation 0.635
|
2.34 percent saturation
Standard Deviation 0.940
|
2.26 percent saturation
Standard Deviation 0.813
|
5.59 percent saturation
Standard Deviation 1.460
|
|
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 12)
|
-3.08 percent saturation
Standard Deviation 2.252
|
-2.75 percent saturation
Standard Deviation 1.863
|
-2.91 percent saturation
Standard Deviation 2.057
|
0.75 percent saturation
Standard Deviation 2.019
|
|
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 18)
|
-2.65 percent saturation
Standard Deviation 1.940
|
-2.33 percent saturation
Standard Deviation 1.994
|
-2.47 percent saturation
Standard Deviation 1.966
|
1.18 percent saturation
Standard Deviation 1.894
|
|
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 24)
|
-3.13 percent saturation
Standard Deviation 1.947
|
-2.89 percent saturation
Standard Deviation 1.941
|
-3.00 percent saturation
Standard Deviation 1.937
|
0.04 percent saturation
Standard Deviation 1.511
|
PRIMARY outcome
Timeframe: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Summary of whole blood white blood cell (WBC) count (10\^3 cells/uL) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV). Blood samples were collected via direct venipuncture at Visits 3, 5, and 7. Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Outcome measures
| Measure |
Test 1
n=127 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=130 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=257 Participants
Combined e-Vapor Use Group
|
Control
n=139 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 3 (Baseline): Week 1
|
7.003 10^3 cells/uL
Standard Deviation 2.3185
|
6.947 10^3 cells/uL
Standard Deviation 1.9468
|
6.974 10^3 cells/uL
Standard Deviation 2.1346
|
6.788 10^3 cells/uL
Standard Deviation 1.9267
|
|
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 5: Week 6
|
6.292 10^3 cells/uL
Standard Deviation 1.6619
|
6.490 10^3 cells/uL
Standard Deviation 1.6780
|
6.391 10^3 cells/uL
Standard Deviation 1.6696
|
6.672 10^3 cells/uL
Standard Deviation 1.8449
|
|
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 7: Week 12
|
6.363 10^3 cells/uL
Standard Deviation 1.6203
|
6.583 10^3 cells/uL
Standard Deviation 1.8742
|
6.477 10^3 cells/uL
Standard Deviation 1.7565
|
6.997 10^3 cells/uL
Standard Deviation 2.0107
|
|
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline (Week 6)
|
-0.656 10^3 cells/uL
Standard Deviation 1.7850
|
-0.490 10^3 cells/uL
Standard Deviation 1.4902
|
-0.573 10^3 cells/uL
Standard Deviation 1.6424
|
-0.098 10^3 cells/uL
Standard Deviation 1.4878
|
|
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline (Week 12)
|
-0.564 10^3 cells/uL
Standard Deviation 1.8111
|
-0.325 10^3 cells/uL
Standard Deviation 1.8580
|
-0.440 10^3 cells/uL
Standard Deviation 1.8356
|
0.227 10^3 cells/uL
Standard Deviation 1.6425
|
PRIMARY outcome
Timeframe: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Summary of Whole Blood WBC Count (10\^3 cells/uL) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV). Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study. Change from Baseline was calculated as follows: Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Outcome measures
| Measure |
Test 1
n=47 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=50 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=97 Participants
Combined e-Vapor Use Group
|
Control
n=49 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Baseline: Week 1
|
6.547 10^3 cells/uL
Standard Deviation 1.6295
|
6.851 10^3 cells/uL
Standard Deviation 1.8432
|
6.704 10^3 cells/uL
Standard Deviation 1.7406
|
7.082 10^3 cells/uL
Standard Deviation 1.9593
|
|
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 1: Week 12
|
6.207 10^3 cells/uL
Standard Deviation 1.6000
|
6.450 10^3 cells/uL
Standard Deviation 1.7554
|
6.332 10^3 cells/uL
Standard Deviation 1.6776
|
7.230 10^3 cells/uL
Standard Deviation 1.9184
|
|
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 3: Week 18
|
5.986 10^3 cells/uL
Standard Deviation 1.2707
|
6.642 10^3 cells/uL
Standard Deviation 1.7254
|
6.347 10^3 cells/uL
Standard Deviation 1.5643
|
7.073 10^3 cells/uL
Standard Deviation 2.0805
|
|
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 5: Week 24
|
5.972 10^3 cells/uL
Standard Deviation 1.2750
|
6.152 10^3 cells/uL
Standard Deviation 1.4051
|
6.067 10^3 cells/uL
Standard Deviation 1.3408
|
7.401 10^3 cells/uL
Standard Deviation 1.6116
|
|
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 12)
|
-0.340 10^3 cells/uL
Standard Deviation 1.3015
|
-0.402 10^3 cells/uL
Standard Deviation 1.7483
|
-0.372 10^3 cells/uL
Standard Deviation 1.5404
|
0.174 10^3 cells/uL
Standard Deviation 1.9309
|
|
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 18)
|
-0.521 10^3 cells/uL
Standard Deviation 1.2722
|
-0.224 10^3 cells/uL
Standard Deviation 1.9141
|
-0.357 10^3 cells/uL
Standard Deviation 1.6547
|
0.035 10^3 cells/uL
Standard Deviation 1.9567
|
|
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 24)
|
-0.622 10^3 cells/uL
Standard Deviation 1.5029
|
-0.762 10^3 cells/uL
Standard Deviation 1.5132
|
-0.696 10^3 cells/uL
Standard Deviation 1.5014
|
0.202 10^3 cells/uL
Standard Deviation 1.5842
|
PRIMARY outcome
Timeframe: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Summary of serum high density lipoprotein cholesterol (HDL-C) (mg/dL) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV). Blood samples were collected via direct venipuncture at Visits 3, 5, and 7. Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Outcome measures
| Measure |
Test 1
n=125 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=130 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=255 Participants
Combined e-Vapor Use Group
|
Control
n=138 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 3 (Baseline): Week 1
|
44.8 mg/dL
Standard Deviation 14.15
|
46.1 mg/dL
Standard Deviation 12.56
|
45.5 mg/dL
Standard Deviation 13.35
|
46.8 mg/dL
Standard Deviation 16.84
|
|
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 5: Week 6
|
47.2 mg/dL
Standard Deviation 15.01
|
48.0 mg/dL
Standard Deviation 12.52
|
47.6 mg/dL
Standard Deviation 13.78
|
47.6 mg/dL
Standard Deviation 18.13
|
|
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 7: Week 12
|
47.3 mg/dL
Standard Deviation 14.43
|
48.9 mg/dL
Standard Deviation 14.52
|
48.2 mg/dL
Standard Deviation 14.46
|
47.4 mg/dL
Standard Deviation 18.00
|
|
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline (Week 6)
|
2.3 mg/dL
Standard Deviation 6.15
|
1.6 mg/dL
Standard Deviation 7.47
|
2.0 mg/dL
Standard Deviation 6.84
|
0.6 mg/dL
Standard Deviation 10.36
|
|
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline (Week 12)
|
3.3 mg/dL
Standard Deviation 6.68
|
3.1 mg/dL
Standard Deviation 9.37
|
3.2 mg/dL
Standard Deviation 8.17
|
0.8 mg/dL
Standard Deviation 8.88
|
PRIMARY outcome
Timeframe: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Summary of serum HDL-C (mg/dL) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV). Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study. Change from Baseline was calculated as follows: Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Outcome measures
| Measure |
Test 1
n=46 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=49 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=95 Participants
Combined e-Vapor Use Group
|
Control
n=49 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 24)
|
4.1 mg/dL
Standard Deviation 9.02
|
3.5 mg/dL
Standard Deviation 13.67
|
3.8 mg/dL
Standard Deviation 11.65
|
-1.1 mg/dL
Standard Deviation 6.79
|
|
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Baseline: Week 1
|
46.3 mg/dL
Standard Deviation 13.05
|
45.2 mg/dL
Standard Deviation 12.29
|
45.7 mg/dL
Standard Deviation 12.61
|
44.4 mg/dL
Standard Deviation 16.04
|
|
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 1: Week 12
|
50.4 mg/dL
Standard Deviation 14.44
|
50.7 mg/dL
Standard Deviation 16.02
|
50.5 mg/dL
Standard Deviation 15.19
|
44.0 mg/dL
Standard Deviation 21.54
|
|
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 3: Week 18
|
48.4 mg/dL
Standard Deviation 13.35
|
47.8 mg/dL
Standard Deviation 14.61
|
48.1 mg/dL
Standard Deviation 13.98
|
44.0 mg/dL
Standard Deviation 22.75
|
|
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 5: Week 24
|
50.6 mg/dL
Standard Deviation 17.37
|
48.5 mg/dL
Standard Deviation 17.95
|
49.5 mg/dL
Standard Deviation 17.61
|
40.8 mg/dL
Standard Deviation 13.01
|
|
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 12)
|
4.2 mg/dL
Standard Deviation 6.51
|
5.5 mg/dL
Standard Deviation 11.96
|
4.8 mg/dL
Standard Deviation 9.68
|
-0.4 mg/dL
Standard Deviation 10.10
|
|
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 18)
|
1.5 mg/dL
Standard Deviation 5.80
|
2.8 mg/dL
Standard Deviation 12.20
|
2.2 mg/dL
Standard Deviation 9.83
|
-0.2 mg/dL
Standard Deviation 12.26
|
PRIMARY outcome
Timeframe: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Summary of urine 8-epi-prostaglandin F2alpha (ng/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV). Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3 The first urine void of the day was collected at Visits 3, 5 and 7. Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration values as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline = Post Product Use Value - Baseline Value
Outcome measures
| Measure |
Test 1
n=127 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=131 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=258 Participants
Combined e-Vapor Use Group
|
Control
n=138 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 3 (Baseline): Week 1
|
377.138 ng/g
Standard Deviation 211.0106
|
355.984 ng/g
Standard Deviation 177.9443
|
366.397 ng/g
Standard Deviation 194.8302
|
368.710 ng/g
Standard Deviation 200.0174
|
|
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 5: Week 6
|
332.952 ng/g
Standard Deviation 212.6164
|
315.095 ng/g
Standard Deviation 150.5924
|
324.096 ng/g
Standard Deviation 184.3240
|
346.856 ng/g
Standard Deviation 195.7020
|
|
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 7: Week 12
|
332.455 ng/g
Standard Deviation 219.2878
|
335.687 ng/g
Standard Deviation 143.1724
|
334.134 ng/g
Standard Deviation 183.3207
|
355.639 ng/g
Standard Deviation 233.4254
|
|
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline (Week 6)
|
-44.354 ng/g
Standard Deviation 162.5679
|
-33.320 ng/g
Standard Deviation 120.3646
|
-38.882 ng/g
Standard Deviation 143.0167
|
-15.247 ng/g
Standard Deviation 141.7366
|
|
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline (Week 12)
|
-39.547 ng/g
Standard Deviation 191.4551
|
-18.092 ng/g
Standard Deviation 135.9049
|
-28.401 ng/g
Standard Deviation 164.9314
|
-7.204 ng/g
Standard Deviation 178.4608
|
PRIMARY outcome
Timeframe: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Summary of urine 8-epi-prostaglandin F2alpha (ng/g) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV). The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study. Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Change from Baseline was calculated as follows: Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Outcome measures
| Measure |
Test 1
n=47 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=50 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=97 Participants
Combined e-Vapor Use Group
|
Control
n=49 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Baseline: Week 1
|
331.217 ng/g
Standard Deviation 145.3767
|
359.269 ng/g
Standard Deviation 204.4360
|
345.677 ng/g
Standard Deviation 177.9266
|
421.529 ng/g
Standard Deviation 277.7803
|
|
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 1: Week 12
|
295.921 ng/g
Standard Deviation 199.4031
|
337.996 ng/g
Standard Deviation 138.6722
|
317.835 ng/g
Standard Deviation 170.8786
|
413.638 ng/g
Standard Deviation 328.9100
|
|
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 3: Week 18
|
251.448 ng/g
Standard Deviation 105.3359
|
314.650 ng/g
Standard Deviation 145.3787
|
285.922 ng/g
Standard Deviation 131.8840
|
403.656 ng/g
Standard Deviation 359.5415
|
|
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 5: Week 24
|
305.481 ng/g
Standard Deviation 310.8112
|
331.678 ng/g
Standard Deviation 190.5315
|
319.453 ng/g
Standard Deviation 252.6784
|
344.100 ng/g
Standard Deviation 142.3191
|
|
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 12)
|
-35.569 ng/g
Standard Deviation 162.6996
|
-21.273 ng/g
Standard Deviation 159.7813
|
-28.123 ng/g
Standard Deviation 160.4950
|
-7.891 ng/g
Standard Deviation 226.9262
|
|
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 18)
|
-87.745 ng/g
Standard Deviation 92.1074
|
-48.891 ng/g
Standard Deviation 115.7881
|
-66.552 ng/g
Standard Deviation 106.8853
|
-20.874 ng/g
Standard Deviation 255.5397
|
|
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 24)
|
-32.869 ng/g
Standard Deviation 328.5303
|
-31.868 ng/g
Standard Deviation 179.4879
|
-32.335 ng/g
Standard Deviation 258.3306
|
-54.946 ng/g
Standard Deviation 159.6202
|
PRIMARY outcome
Timeframe: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Summary of urine 11-dehydrothromboxane B2 (ng/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV). Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3 The first urine void of the day was collected at Visits 3, 5 and 7. Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration values as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline = Post Product Use Value - Baseline Value
Outcome measures
| Measure |
Test 1
n=126 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=131 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=257 Participants
Combined e-Vapor Use Group
|
Control
n=136 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 3 (Baseline): Week 1
|
824.877 ng/g
Standard Deviation 726.5075
|
761.598 ng/g
Standard Deviation 518.6039
|
792.622 ng/g
Standard Deviation 628.7305
|
785.424 ng/g
Standard Deviation 457.4472
|
|
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 5: Week 6
|
680.700 ng/g
Standard Deviation 371.6959
|
614.562 ng/g
Standard Deviation 312.1994
|
647.766 ng/g
Standard Deviation 344.2553
|
776.000 ng/g
Standard Deviation 480.7616
|
|
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 7: Week 12
|
703.664 ng/g
Standard Deviation 444.1672
|
714.007 ng/g
Standard Deviation 413.0628
|
709.060 ng/g
Standard Deviation 427.3102
|
777.506 ng/g
Standard Deviation 471.4327
|
|
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline (Week 6)
|
-148.001 ng/g
Standard Deviation 660.1311
|
-141.502 ng/g
Standard Deviation 409.6231
|
-144.765 ng/g
Standard Deviation 548.7304
|
-2.414 ng/g
Standard Deviation 427.2816
|
|
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline (Week 12)
|
-47.736 ng/g
Standard Deviation 488.1213
|
-55.751 ng/g
Standard Deviation 486.6897
|
-51.917 ng/g
Standard Deviation 486.3259
|
5.028 ng/g
Standard Deviation 424.6884
|
PRIMARY outcome
Timeframe: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Summary of urine 11-dehydrothromboxane B2 (ng/g) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV). The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study. Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Change from Baseline was calculated as follows: Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Outcome measures
| Measure |
Test 1
n=47 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=50 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=97 Participants
Combined e-Vapor Use Group
|
Control
n=48 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Baseline: Week 1
|
710.827 ng/g
Standard Deviation 429.3286
|
750.519 ng/g
Standard Deviation 463.9992
|
731.287 ng/g
Standard Deviation 445.6561
|
842.642 ng/g
Standard Deviation 493.4473
|
|
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 1: Week 12
|
616.618 ng/g
Standard Deviation 317.4293
|
703.961 ng/g
Standard Deviation 467.6549
|
662.109 ng/g
Standard Deviation 403.0592
|
856.055 ng/g
Standard Deviation 517.3135
|
|
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 3: Week 18
|
665.371 ng/g
Standard Deviation 399.2899
|
731.003 ng/g
Standard Deviation 403.6885
|
701.170 ng/g
Standard Deviation 400.7346
|
942.559 ng/g
Standard Deviation 644.6484
|
|
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 5: Week 24
|
567.102 ng/g
Standard Deviation 375.2503
|
706.929 ng/g
Standard Deviation 341.1676
|
641.676 ng/g
Standard Deviation 362.2939
|
969.562 ng/g
Standard Deviation 545.1937
|
|
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 12)
|
-93.029 ng/g
Standard Deviation 372.9436
|
-46.559 ng/g
Standard Deviation 438.0320
|
-68.826 ng/g
Standard Deviation 406.6859
|
6.436 ng/g
Standard Deviation 462.7865
|
|
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 18)
|
-68.815 ng/g
Standard Deviation 363.6867
|
-14.677 ng/g
Standard Deviation 390.0280
|
-39.285 ng/g
Standard Deviation 377.1052
|
107.568 ng/g
Standard Deviation 617.2994
|
|
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 24)
|
-165.586 ng/g
Standard Deviation 402.1370
|
-47.287 ng/g
Standard Deviation 382.6278
|
-102.493 ng/g
Standard Deviation 394.1247
|
103.927 ng/g
Standard Deviation 469.7284
|
PRIMARY outcome
Timeframe: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Summary of plasma soluble Intercellular Adhesion Molecule-1 (sICAM-1) (ng/mL) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV). Blood samples were collected via direct venipuncture at Visits 3, 5, and 7. Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Outcome measures
| Measure |
Test 1
n=127 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=131 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=258 Participants
Combined e-Vapor Use Group
|
Control
n=139 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 3 (Baseline): Week 1
|
230.4 ng/mL
Standard Deviation 76.704
|
222.8 ng/mL
Standard Deviation 77.888
|
226.6 ng/mL
Standard Deviation 77.250
|
230.6 ng/mL
Standard Deviation 77.084
|
|
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 5: Week 6
|
198.5 ng/mL
Standard Deviation 54.783
|
199.8 ng/mL
Standard Deviation 65.911
|
199.2 ng/mL
Standard Deviation 60.529
|
224.6 ng/mL
Standard Deviation 64.515
|
|
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 7: Week 12
|
204.1 ng/mL
Standard Deviation 58.502
|
197.7 ng/mL
Standard Deviation 71.517
|
200.8 ng/mL
Standard Deviation 65.523
|
224.3 ng/mL
Standard Deviation 70.515
|
|
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline (Week 6)
|
-31.96 ng/mL
Standard Deviation 50.532
|
-22.43 ng/mL
Standard Deviation 47.510
|
-27.16 ng/mL
Standard Deviation 49.166
|
-6.613 ng/mL
Standard Deviation 39.668
|
|
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline (Week 12)
|
-23.71 ng/mL
Standard Deviation 52.739
|
-25.34 ng/mL
Standard Deviation 46.825
|
-24.56 ng/mL
Standard Deviation 49.652
|
-7.056 ng/mL
Standard Deviation 37.619
|
PRIMARY outcome
Timeframe: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Summary of plasma sICAM-1 (ng/mL) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV). Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study. Change from Baseline was calculated as follows: Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Outcome measures
| Measure |
Test 1
n=47 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=50 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=97 Participants
Combined e-Vapor Use Group
|
Control
n=49 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Baseline: Week 1
|
206.6 ng/mL
Standard Deviation 60.303
|
205.0 ng/mL
Standard Deviation 57.117
|
205.8 ng/mL
Standard Deviation 58.381
|
241.3 ng/mL
Standard Deviation 81.966
|
|
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 1: Week 12
|
184.0 ng/mL
Standard Deviation 48.515
|
176.7 ng/mL
Standard Deviation 41.375
|
180.2 ng/mL
Standard Deviation 44.893
|
229.5 ng/mL
Standard Deviation 69.888
|
|
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 3: Week 18
|
187.9 ng/mL
Standard Deviation 52.027
|
182.2 ng/mL
Standard Deviation 50.009
|
184.8 ng/mL
Standard Deviation 50.712
|
244.9 ng/mL
Standard Deviation 85.893
|
|
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 5: Week 24
|
184.4 ng/mL
Standard Deviation 55.223
|
184.7 ng/mL
Standard Deviation 62.726
|
184.6 ng/mL
Standard Deviation 58.971
|
244.3 ng/mL
Standard Deviation 78.272
|
|
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 12)
|
-22.54 ng/mL
Standard Deviation 45.013
|
-28.33 ng/mL
Standard Deviation 49.987
|
-25.52 ng/mL
Standard Deviation 47.484
|
-11.80 ng/mL
Standard Deviation 36.195
|
|
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 18)
|
-26.73 ng/mL
Standard Deviation 53.383
|
-23.27 ng/mL
Standard Deviation 57.191
|
-24.82 ng/mL
Standard Deviation 55.227
|
1.702 ng/mL
Standard Deviation 47.092
|
|
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 24)
|
-25.36 ng/mL
Standard Deviation 56.800
|
-21.06 ng/mL
Standard Deviation 67.737
|
-23.09 ng/mL
Standard Deviation 62.500
|
2.091 ng/mL
Standard Deviation 47.116
|
PRIMARY outcome
Timeframe: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomizationPopulation: Modified ITT Population with Outliers Excluded: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker. Data outliers, defined as any observation with a studentized residual that is greater than +/- 4, were excluded from the analysis.
Summary of whole blood WBC absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV). Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12). Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Outcome measures
| Measure |
Test 1
n=110 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=118 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=128 Participants
Combined e-Vapor Use Group
|
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Whole Blood WBC Absolute Change From Baseline (10^3 Cells/uL) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
|
-0.564 10^3 cells/uL
Standard Deviation 1.8111
|
-0.389 10^3 cells/uL
Standard Deviation 1.7261
|
0.227 10^3 cells/uL
Standard Deviation 1.6425
|
—
|
PRIMARY outcome
Timeframe: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomizationPopulation: Modified ITT Population with Outliers Excluded: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker. Data outliers, defined as any observation with a studentized residual that is greater than +/- 4, were excluded from the analysis.
Summary of serum HDL-C absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV). Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12). Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Outcome measures
| Measure |
Test 1
n=110 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=117 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=127 Participants
Combined e-Vapor Use Group
|
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Serum HDL-C Absolute Change From Baseline (mg/dL) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
|
3.3 mg/dL
Standard Deviation 6.68
|
2.3 mg/dL
Standard Deviation 6.95
|
0.4 mg/dL
Standard Deviation 7.54
|
—
|
PRIMARY outcome
Timeframe: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomizationPopulation: Modified ITT Population with Outliers Excluded: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker. Data outliers, defined as any observation with a studentized residual that is greater than +/- 4, were excluded from the analysis.
Summary of urine 8-epi-prostaglandin F2alpha absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV). The first urine void of the day on Visits 3 and 7 was analyzed for the urine biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12). Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Outcome measures
| Measure |
Test 1
n=108 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=120 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=125 Participants
Combined e-Vapor Use Group
|
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Urine 8-epi-prostaglandin F2alpha Absolute Change From Baseline (ng/g) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
|
-61.644 ng/g
Standard Deviation 138.3599
|
-18.092 ng/g
Standard Deviation 135.9049
|
-11.452 ng/g
Standard Deviation 133.6618
|
—
|
PRIMARY outcome
Timeframe: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomizationPopulation: Modified ITT Population with Outliers Excluded: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker. Data outliers, defined as any observation with a studentized residual that is greater than +/- 4, were excluded from the analysis.
Summary of urine 11-dehydrothromboxane B2 absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV). The first urine void of the day on Visits 3 and 7 was analyzed for the urine biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12). Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Outcome measures
| Measure |
Test 1
n=110 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=120 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=124 Participants
Combined e-Vapor Use Group
|
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Urine 11-dehydrothromboxane B2 Absolute Change From Baseline (ng/g) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
|
-47.736 ng/g
Standard Deviation 488.1213
|
-55.751 ng/g
Standard Deviation 486.6897
|
-3.878 ng/g
Standard Deviation 414.5263
|
—
|
PRIMARY outcome
Timeframe: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomizationPopulation: Modified ITT Population with Outliers Excluded: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker. Data outliers, defined as any observation with a studentized residual that is greater than +/- 4, were excluded from the analysis.
Summary of plasma sICAM-1 absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV). Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12). Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Outcome measures
| Measure |
Test 1
n=111 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=119 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=129 Participants
Combined e-Vapor Use Group
|
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Plasma sICAM-1 Absolute Change From Baseline (ng/mL) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
|
-23.71 ng/mL
Standard Deviation 52.739
|
-26.02 ng/mL
Standard Deviation 46.433
|
-7.056 ng/mL
Standard Deviation 37.619
|
—
|
PRIMARY outcome
Timeframe: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomizationPopulation: Modified ITT Population with Outliers Excluded: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker. Data outliers, defined as any observation with a studentized residual that is greater than +/- 4, were excluded from the analysis.
Summary of urine total NNAL absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV). The first urine void of the day on Visits 3 and 7 was analyzed for the urine biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12). Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Outcome measures
| Measure |
Test 1
n=112 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=120 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=128 Participants
Combined e-Vapor Use Group
|
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Urine Total NNAL Absolute Change From Baseline (ng/g) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
|
-191.327 ng/g
Standard Deviation 220.6982
|
-160.201 ng/g
Standard Deviation 192.1456
|
-15.898 ng/g
Standard Deviation 149.1447
|
—
|
PRIMARY outcome
Timeframe: Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomizationPopulation: Modified ITT Population with Outliers Excluded: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker. Data outliers, defined as any observation with a studentized residual that is greater than +/- 4, were excluded from the analysis.
Summary of whole blood COHB absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV). Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12). Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Outcome measures
| Measure |
Test 1
n=110 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=120 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=128 Participants
Combined e-Vapor Use Group
|
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Whole Blood COHB Absolute Change From Baseline (% Saturation) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
|
-2.57 percent saturation
Standard Deviation 2.363
|
-2.44 percent saturation
Standard Deviation 2.187
|
0.07 percent saturation
Standard Deviation 1.920
|
—
|
SECONDARY outcome
Timeframe: Weeks 12 (Study ALCS-RA-16-06-EV) and Week 24 (Study ALCS-RA-17-11-EV) from randomizationPopulation: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Participant compliance for the abstention of any type of tobacco/nicotine product for the duration of the study was assessed by measuring the participant's exhaled carbon monoxide (eCO, ppm). According to their eCO measurements at Weeks 12 (study ALCS-RA-16-06-EV) and Week 24 (study ALCS-RA-17-11-EV), participants were categorized into 1 of 3 categories: 'eCO ≤ 5', 'eCO \< 5 - ≤ 8', or 'eCO \> 8'. Lower eCO values represent lower smoking exposure and increased compliance, with the 'eCO ≤ 5' category indicating that the participant abstained from smoking, the 'eCO \< 5 - ≤ 8' category indicating low smoking exposure to the participant, and the 'eCO \> 8' category indicating non-compliance with the study criteria that the participant refrain from smoking during the study.
Outcome measures
| Measure |
Test 1
n=112 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=121 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
Combined e-Vapor Use Group
|
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Frequency of eCO as Compliance Indicator, Weeks 12 (Study ALCS-RA-16-06-EV) and 24 (Study ALCS-RA-17-11-EV)
Exhaled CO at Week 12 · eCO ≤ 5
|
76 Participants
|
77 Participants
|
—
|
—
|
|
Frequency of eCO as Compliance Indicator, Weeks 12 (Study ALCS-RA-16-06-EV) and 24 (Study ALCS-RA-17-11-EV)
Exhaled CO at Week 12 · eCO < 5 - ≤ 8
|
13 Participants
|
21 Participants
|
—
|
—
|
|
Frequency of eCO as Compliance Indicator, Weeks 12 (Study ALCS-RA-16-06-EV) and 24 (Study ALCS-RA-17-11-EV)
Exhaled CO at Week 12 · eCO > 8
|
23 Participants
|
23 Participants
|
—
|
—
|
|
Frequency of eCO as Compliance Indicator, Weeks 12 (Study ALCS-RA-16-06-EV) and 24 (Study ALCS-RA-17-11-EV)
Exhaled CO at Week 24 · eCO ≤ 5
|
35 Participants
|
40 Participants
|
—
|
—
|
|
Frequency of eCO as Compliance Indicator, Weeks 12 (Study ALCS-RA-16-06-EV) and 24 (Study ALCS-RA-17-11-EV)
Exhaled CO at Week 24 · eCO < 5 - ≤ 8
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Frequency of eCO as Compliance Indicator, Weeks 12 (Study ALCS-RA-16-06-EV) and 24 (Study ALCS-RA-17-11-EV)
Exhaled CO at Week 24 · eCO > 8
|
2 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessments at Screening (Day -28 to Day -5) and Week 12 (Day 84 +/- 3 )Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Percentage of predicted forced expiratory volume in the first second (FEV1) and absolute change from Baseline to Week 12 by Study Group is presented (Study ALCS-RA-16-06-EV). Baseline / Screening = Day -28 to Day -5 Visit 7 (Week 12) = Day 84 ± 3 Absolute change from baseline = Post Product Use Value - Baseline Value FEV1 = Forced Expiratory Volume in 1 Second
Outcome measures
| Measure |
Test 1
n=100 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=112 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=212 Participants
Combined e-Vapor Use Group
|
Control
n=115 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Percentage of Predicted FEV1 and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Screening (Baseline)
|
91.059 percentage of predicted FEV1
Standard Deviation 13.9979
|
91.335 percentage of predicted FEV1
Standard Deviation 12.8396
|
91.205 percentage of predicted FEV1
Standard Deviation 13.3671
|
90.139 percentage of predicted FEV1
Standard Deviation 13.4146
|
|
Percentage of Predicted FEV1 and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Week 12
|
89.989 percentage of predicted FEV1
Standard Deviation 13.7140
|
90.918 percentage of predicted FEV1
Standard Deviation 13.3174
|
90.480 percentage of predicted FEV1
Standard Deviation 13.4818
|
87.743 percentage of predicted FEV1
Standard Deviation 13.4729
|
|
Percentage of Predicted FEV1 and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline at Week 12
|
-1.070 percentage of predicted FEV1
Standard Deviation 6.5798
|
-0.416 percentage of predicted FEV1
Standard Deviation 5.4848
|
-0.725 percentage of predicted FEV1
Standard Deviation 6.0205
|
-2.396 percentage of predicted FEV1
Standard Deviation 6.2471
|
SECONDARY outcome
Timeframe: Assessments at Screening (Day -28 to Day -5) and Week 12 (Day 84 +/- 3 )Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Percentage of predicted forced vital capacity (FVC) and absolute change from Baseline to Week 12 by Study Group is presented (Study ALCS-RA-16-06-EV). Baseline / Screening = Day -28 to Day -5 Visit 7 (Week 12) = Day 84 ± 3 Absolute change from baseline = Post Product Use Value - Baseline Value FVC = Forced Vital Capacity
Outcome measures
| Measure |
Test 1
n=100 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=112 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=212 Participants
Combined e-Vapor Use Group
|
Control
n=115 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Percentage of Predicted FVC and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Screening (Baseline)
|
92.709 percentage of predicted FVC
Standard Deviation 12.7747
|
93.789 percentage of predicted FVC
Standard Deviation 11.7222
|
93.280 percentage of predicted FVC
Standard Deviation 12.2126
|
92.809 percentage of predicted FVC
Standard Deviation 12.2784
|
|
Percentage of Predicted FVC and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Week 12
|
91.733 percentage of predicted FVC
Standard Deviation 13.3234
|
92.730 percentage of predicted FVC
Standard Deviation 11.9222
|
92.260 percentage of predicted FVC
Standard Deviation 12.5822
|
91.552 percentage of predicted FVC
Standard Deviation 12.7403
|
|
Percentage of Predicted FVC and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline at Week 12
|
-0.976 percentage of predicted FVC
Standard Deviation 5.1281
|
-1.059 percentage of predicted FVC
Standard Deviation 5.3244
|
-1.020 percentage of predicted FVC
Standard Deviation 5.2205
|
-1.257 percentage of predicted FVC
Standard Deviation 5.1665
|
SECONDARY outcome
Timeframe: Assessments at Screening (Day -28 to Day -5) and Week 12 (Day 84 +/- 3 )Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Percentage of predicted FEV1/FVC and absolute change from Baseline to Week 12 by Study Group is presented (Study ALCS-RA-16-06-EV). Baseline / Screening = Day -28 to Day -5 Visit 7 (Week 12) = Day 84 ± 3 Absolute change from baseline = Post Product Use Value - Baseline Value FEV1 = Forced Expiratory Volume in 1 Second, FVC = Forced Vital Capacity.
Outcome measures
| Measure |
Test 1
n=100 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=112 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=212 Participants
Combined e-Vapor Use Group
|
Control
n=115 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Percentage of Predicted FEV1/FVC and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Screening (Baseline)
|
98.202 percentage of predicted FEV1/FVC
Standard Deviation 7.5989
|
97.535 percentage of predicted FEV1/FVC
Standard Deviation 7.9699
|
97.849 percentage of predicted FEV1/FVC
Standard Deviation 7.7859
|
97.243 percentage of predicted FEV1/FVC
Standard Deviation 8.1131
|
|
Percentage of Predicted FEV1/FVC and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Week 12
|
98.219 percentage of predicted FEV1/FVC
Standard Deviation 7.7279
|
98.135 percentage of predicted FEV1/FVC
Standard Deviation 7.3706
|
98.175 percentage of predicted FEV1/FVC
Standard Deviation 7.5234
|
95.959 percentage of predicted FEV1/FVC
Standard Deviation 8.1492
|
|
Percentage of Predicted FEV1/FVC and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline at Week 12
|
0.017 percentage of predicted FEV1/FVC
Standard Deviation 4.4796
|
0.600 percentage of predicted FEV1/FVC
Standard Deviation 3.3508
|
0.325 percentage of predicted FEV1/FVC
Standard Deviation 3.9251
|
-1.285 percentage of predicted FEV1/FVC
Standard Deviation 5.5994
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Summary of urine Nicotine Equivalents (mg/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV). The first urine void of the day was collected at Visits 3, 5 and 7. Nicotine equivalents (μg/mL) = (nicotine \[ng/mL\]/162.23 \[mg/mmol\] + nicotinegluc (ng/mL)/338.36 \[mg/mmol\] + cotinine \[ng/mL\]/176.22 \[mg/mmol\] + cotininegluc \[ng/mL\]/352.34 \[mg/mmol\] + trans-3'-hydroxycotinine \[ng/mL\]/192.22 \[mg/mmol\] + trans-3'-hydroxycotinine-gluc \[ng/mL\]/368.34 \[mg/mmol\]) x 162.23 (mg/mmol) x 1 μg/1000 ng Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Absolute change from baseline = Post Product Use Value - Baseline Value Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Outcome measures
| Measure |
Test 1
n=127 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=131 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=258 Participants
Combined e-Vapor Use Group
|
Control
n=138 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Urine Nicotine Equivalents and Absolute Change From Baseline (mg/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 3 (Baseline): Week 1
|
10.865 mg/g
Standard Deviation 5.6124
|
10.629 mg/g
Standard Deviation 5.5776
|
10.745 mg/g
Standard Deviation 5.5851
|
11.126 mg/g
Standard Deviation 5.5647
|
|
Summary of Urine Nicotine Equivalents and Absolute Change From Baseline (mg/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 5: Week 6
|
10.666 mg/g
Standard Deviation 7.4649
|
10.026 mg/g
Standard Deviation 7.0465
|
10.347 mg/g
Standard Deviation 7.2519
|
10.766 mg/g
Standard Deviation 5.3662
|
|
Summary of Urine Nicotine Equivalents and Absolute Change From Baseline (mg/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Visit 7: Week 12
|
10.869 mg/g
Standard Deviation 7.5555
|
11.054 mg/g
Standard Deviation 7.0353
|
10.965 mg/g
Standard Deviation 7.2768
|
10.268 mg/g
Standard Deviation 5.5748
|
|
Summary of Urine Nicotine Equivalents and Absolute Change From Baseline (mg/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline (Week 6)
|
-0.109 mg/g
Standard Deviation 5.7252
|
-0.600 mg/g
Standard Deviation 5.0695
|
-0.353 mg/g
Standard Deviation 5.4032
|
-0.499 mg/g
Standard Deviation 3.4735
|
|
Summary of Urine Nicotine Equivalents and Absolute Change From Baseline (mg/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Change from Baseline (Week 12)
|
0.219 mg/g
Standard Deviation 5.2922
|
0.435 mg/g
Standard Deviation 4.9935
|
0.330 mg/g
Standard Deviation 5.1304
|
-0.943 mg/g
Standard Deviation 3.4975
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]Population: Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Summary of urine nicotine equivalents (mg/g Cr) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV). The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study. Nicotine equivalents (μg/mL) = (nicotine \[ng/mL\]/162.23 \[mg/mmol\] + nicotinegluc (ng/mL)/338.36 \[mg/mmol\] + cotinine \[ng/mL\]/176.22 \[mg/mmol\] + cotininegluc \[ng/mL\]/352.34 \[mg/mmol\] + trans-3'-hydroxycotinine \[ng/mL\]/192.22 \[mg/mmol\] + trans-3'-hydroxycotinine-gluc \[ng/mL\]/368.34 \[mg/mmol\]) x 162.23 (mg/mmol) x 1 μg/1000 ng Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows: Urine biomarker (ng/g creatinine) = urine biomarker (pg/mL) x 100 / creatinine (mg/dL) Change from Baseline was calculated as follows: Absolute change from baseline = Post Product Use Value - Baseline Val
Outcome measures
| Measure |
Test 1
n=47 Participants
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
|
Test 2
n=50 Participants
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL\* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
\*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
|
Test 1 + Test 2 Group
n=97 Participants
Combined e-Vapor Use Group
|
Control
n=49 Participants
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
|
|---|---|---|---|---|
|
Summary of Urine Nicotine Equivalents and Absolute Change From Baseline (mg/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Baseline: Week 1
|
10.107 mg/g
Standard Deviation 4.9952
|
10.684 mg/g
Standard Deviation 5.2636
|
10.404 mg/g
Standard Deviation 5.1168
|
11.813 mg/g
Standard Deviation 5.4517
|
|
Summary of Urine Nicotine Equivalents and Absolute Change From Baseline (mg/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 1: Week 12
|
10.412 mg/g
Standard Deviation 7.7828
|
11.949 mg/g
Standard Deviation 7.0536
|
11.205 mg/g
Standard Deviation 7.4173
|
11.101 mg/g
Standard Deviation 5.7563
|
|
Summary of Urine Nicotine Equivalents and Absolute Change From Baseline (mg/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 3: Week 18
|
12.421 mg/g
Standard Deviation 9.6385
|
11.634 mg/g
Standard Deviation 7.8863
|
11.992 mg/g
Standard Deviation 8.6833
|
10.841 mg/g
Standard Deviation 5.4127
|
|
Summary of Urine Nicotine Equivalents and Absolute Change From Baseline (mg/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Visit 5: Week 24
|
10.621 mg/g
Standard Deviation 8.5013
|
12.782 mg/g
Standard Deviation 7.1436
|
11.773 mg/g
Standard Deviation 7.8370
|
10.442 mg/g
Standard Deviation 4.5456
|
|
Summary of Urine Nicotine Equivalents and Absolute Change From Baseline (mg/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 12)
|
0.305 mg/g
Standard Deviation 5.4615
|
1.266 mg/g
Standard Deviation 5.5160
|
0.800 mg/g
Standard Deviation 5.4823
|
-0.713 mg/g
Standard Deviation 3.9573
|
|
Summary of Urine Nicotine Equivalents and Absolute Change From Baseline (mg/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 18)
|
2.360 mg/g
Standard Deviation 6.9077
|
1.281 mg/g
Standard Deviation 6.3017
|
1.771 mg/g
Standard Deviation 6.5677
|
-0.976 mg/g
Standard Deviation 4.4242
|
|
Summary of Urine Nicotine Equivalents and Absolute Change From Baseline (mg/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Change from Baseline (Week 24)
|
0.680 mg/g
Standard Deviation 5.9020
|
2.103 mg/g
Standard Deviation 7.0107
|
1.439 mg/g
Standard Deviation 6.5202
|
-1.372 mg/g
Standard Deviation 4.1783
|
Adverse Events
Test 1 (ALCS-RA-16-06-EV)
Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths
Test 2 (ALCS-RA-16-06-EV)
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Control (ALCS-RA-16-06-EV)
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Overall (ALCS-RA-16-06-EV)
Serious events: 3 serious events
Other events: 120 other events
Deaths: 0 deaths
Test 1 (ALCS-RA-17-11-EV)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Test 2 (ALCS-RA-17-11-EV)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Control (ALCS-RA-17-11-EV)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Overall (ALCS-RA-17-11-EV)
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test 1 (ALCS-RA-16-06-EV)
n=151 participants at risk
Subjects were instructed to stop use of their own brand of cigarettes and were provided with exclusive ad libitum use of e-vapor Test Product 1 (Nu Mark LLC, MarkTen® XL Bold CLASSIC\*) without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-16-06-EV.
\*Product no longer sold commercially
|
Test 2 (ALCS-RA-16-06-EV)
n=150 participants at risk
Subjects were instructed to stop use of their own brand of cigarettes and were provided with exclusive ad libitum use of e-vapor Test Product 2 (Nu Mark LLC, MarkTen® XL Bold MENTHOL\*) without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-16-06-EV.
\*Product no longer sold commercially
|
Control (ALCS-RA-16-06-EV)
n=149 participants at risk
Subjects continued smoking their own brand of conventional lit-end cigarettes under ad libitum use of, without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-16-06-EV.
|
Overall (ALCS-RA-16-06-EV)
n=450 participants at risk
This group consists of all subjects who participated in study ALCS-RA-16-06-EV and were assigned to the Test 1 group, the Test 2 group or the Control group.
|
Test 1 (ALCS-RA-17-11-EV)
n=48 participants at risk
Subjects were instructed to stop use of their own brand of cigarettes and were provided with exclusive ad libitum use of e-vapor Test Product 1 (Nu Mark LLC, MarkTen® XL Bold CLASSIC\*) without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-17-11-EV.
\*Product no longer sold commercially
|
Test 2 (ALCS-RA-17-11-EV)
n=50 participants at risk
Subjects were instructed to stop use of their own brand of cigarettes and were provided with exclusive ad libitum use of e-vapor Test Product 2 (Nu Mark LLC, MarkTen® XL Bold MENTHOL\*) without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-17-11-EV.
\*Product no longer sold commercially
|
Control (ALCS-RA-17-11-EV)
n=52 participants at risk
Subjects continued smoking their own brand of conventional lit-end cigarettes under ad libitum use of, without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-17-11-EV.
|
Overall (ALCS-RA-17-11-EV)
n=150 participants at risk
This group consists of all subjects who participated in study ALCS-RA-17-11-EV and were assigned to the Test 1 group, the Test 2 group or the Control group.
|
|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Multiple fractures secondary to motor vehicle accident
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Pregnancy, puerperium and perinatal conditions
MISCARRIAGE
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
Other adverse events
| Measure |
Test 1 (ALCS-RA-16-06-EV)
n=151 participants at risk
Subjects were instructed to stop use of their own brand of cigarettes and were provided with exclusive ad libitum use of e-vapor Test Product 1 (Nu Mark LLC, MarkTen® XL Bold CLASSIC\*) without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-16-06-EV.
\*Product no longer sold commercially
|
Test 2 (ALCS-RA-16-06-EV)
n=150 participants at risk
Subjects were instructed to stop use of their own brand of cigarettes and were provided with exclusive ad libitum use of e-vapor Test Product 2 (Nu Mark LLC, MarkTen® XL Bold MENTHOL\*) without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-16-06-EV.
\*Product no longer sold commercially
|
Control (ALCS-RA-16-06-EV)
n=149 participants at risk
Subjects continued smoking their own brand of conventional lit-end cigarettes under ad libitum use of, without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-16-06-EV.
|
Overall (ALCS-RA-16-06-EV)
n=450 participants at risk
This group consists of all subjects who participated in study ALCS-RA-16-06-EV and were assigned to the Test 1 group, the Test 2 group or the Control group.
|
Test 1 (ALCS-RA-17-11-EV)
n=48 participants at risk
Subjects were instructed to stop use of their own brand of cigarettes and were provided with exclusive ad libitum use of e-vapor Test Product 1 (Nu Mark LLC, MarkTen® XL Bold CLASSIC\*) without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-17-11-EV.
\*Product no longer sold commercially
|
Test 2 (ALCS-RA-17-11-EV)
n=50 participants at risk
Subjects were instructed to stop use of their own brand of cigarettes and were provided with exclusive ad libitum use of e-vapor Test Product 2 (Nu Mark LLC, MarkTen® XL Bold MENTHOL\*) without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-17-11-EV.
\*Product no longer sold commercially
|
Control (ALCS-RA-17-11-EV)
n=52 participants at risk
Subjects continued smoking their own brand of conventional lit-end cigarettes under ad libitum use of, without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-17-11-EV.
|
Overall (ALCS-RA-17-11-EV)
n=150 participants at risk
This group consists of all subjects who participated in study ALCS-RA-17-11-EV and were assigned to the Test 1 group, the Test 2 group or the Control group.
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.9%
1/52 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.9%
1/52 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Blood and lymphatic system disorders
Haemoconcentration
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.9%
1/52 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Cardiac disorders
Sinus bradycardia
|
1.3%
2/151 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
3/450 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Congenital, familial and genetic disorders
Osteogenesis imperfecta
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Congenital, familial and genetic disorders
Thyroglossal cyst
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Eye disorders
Dry eye
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Eye disorders
Eye irritation
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Gastrointestinal disorders
Cheilitis
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.9%
1/52 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
2/151 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
3/150 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.1%
5/450 • Number of events 5 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
3/151 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.7%
4/150 • Number of events 4 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.6%
7/450 • Number of events 7 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.9%
1/52 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Gastrointestinal disorders
Gingival recession
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Gastrointestinal disorders
Nausea
|
1.3%
2/151 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.1%
5/450 • Number of events 5 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Gastrointestinal disorders
Stomatitis
|
1.3%
2/151 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
3/450 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
4.0%
2/50 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Gastrointestinal disorders
Vomiting
|
0.66%
1/151 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
General disorders
Fatigue
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
General disorders
Feeling jittery
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
General disorders
Non-cardiac chest pain
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
4.2%
2/48 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Immune system disorders
Multiple allergies
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.9%
1/52 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Asymptomatic bacteriuria
|
1.3%
2/151 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Bronchitis
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
3/450 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Conjunctivitis
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Furuncle
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Gingivitis
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Influenza
|
1.3%
2/151 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
3/450 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Kidney infection
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Otitis media
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Sinusitis
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
3/450 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Tooth infection
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
5/151 • Number of events 6 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
3/150 • Number of events 8 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.8%
8/450 • Number of events 14 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Urinary tract infection
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.89%
4/450 • Number of events 4 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Vaginal infection
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.89%
4/450 • Number of events 4 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.9%
1/52 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
3/450 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 4 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.89%
4/450 • Number of events 6 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
4.2%
2/48 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
6.0%
3/50 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
3/150 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Investigations
Bilirubin urine present
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Investigations
Colonoscopy
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.9%
1/52 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Investigations
Haematocrit increased
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Investigations
Neutrophil count increased
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Investigations
Urine ketone body present
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Investigations
Urobilinogen urine increased
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Investigations
Weight increased
|
1.3%
2/151 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Metabolism and nutrition disorders
Food craving
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
3/150 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.1%
5/450 • Number of events 5 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.9%
1/52 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
3/150 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.9%
1/52 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papilloma of breast
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral papilloma
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Nervous system disorders
Dizziness
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.9%
1/52 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Nervous system disorders
Headache
|
3.3%
5/151 • Number of events 6 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
3/150 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/149 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.2%
10/450 • Number of events 11 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Nervous system disorders
Presyncope
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Nervous system disorders
Sinus headache
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Nervous system disorders
Syncope
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Psychiatric disorders
Anxiety
|
1.3%
2/151 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.1%
5/450 • Number of events 5 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Psychiatric disorders
Depression
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Renal and urinary disorders
Haematuria
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.9%
1/52 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Renal and urinary disorders
Polyuria
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Renal and urinary disorders
Proteinuria
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.9%
1/52 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
5/151 • Number of events 5 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
4.7%
7/150 • Number of events 7 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.9%
13/450 • Number of events 13 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.9%
1/52 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
3/450 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.3%
2/151 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/149 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.89%
4/450 • Number of events 4 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
2.0%
3/151 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
3/150 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
6/450 • Number of events 6 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
4.0%
2/50 • Number of events 3 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
3/150 • Number of events 4 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.0%
1/50 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.66%
1/151 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/450 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/149 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.22%
1/450 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Vascular disorders
Haematoma
|
1.3%
2/151 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
2.1%
1/48 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.67%
1/150 • Number of events 1 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
|
Vascular disorders
Hypertension
|
0.00%
0/151 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
1.3%
2/150 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/149 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.44%
2/450 • Number of events 2 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/48 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/50 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/52 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
0.00%
0/150 • Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
|
Additional Information
Jeffery Edmiston, Functional Director Clinical Research
Altria
Phone: 8043352366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place