Trial Outcomes & Findings for A Study of ARRY-438162 in Patients With Rheumatoid Arthritis (NCT NCT00650767)
NCT ID: NCT00650767
Last Updated: 2020-12-01
Results Overview
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
201 participants
Primary outcome timeframe
Week 12
Results posted on
2020-12-01
Participant Flow
The ARRAY-162-201 study began recruitment on 04-April-2008 (First Patient First Visit) and concluded on 07-July-2009 (Last Patient Last Visit). This study was conducted at 36 sites in the United States, Europe and South America.
Participant Flow and Baseline Demographics represent the Intent-to-Treat (ITT) population, which is all patients who were randomized to a treatment group.
Participant milestones
| Measure |
Placebo
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 20 mg Bid
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
50
|
50
|
|
Overall Study
COMPLETED
|
46
|
41
|
36
|
39
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
14
|
11
|
Reasons for withdrawal
| Measure |
Placebo
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 20 mg Bid
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
10
|
8
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
0
|
|
Overall Study
Other
|
1
|
1
|
0
|
0
|
Baseline Characteristics
A Study of ARRY-438162 in Patients With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Placebo
n=51 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
174 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 12.67 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 11.98 • n=7 Participants
|
54.8 years
STANDARD_DEVIATION 11.88 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 11.74 • n=4 Participants
|
52.6 years
STANDARD_DEVIATION 11.89 • n=21 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
172 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic Or Latino
|
24 participants
n=5 Participants
|
21 participants
n=7 Participants
|
23 participants
n=5 Participants
|
24 participants
n=4 Participants
|
92 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic Or Latino
|
27 participants
n=5 Participants
|
29 participants
n=7 Participants
|
27 participants
n=5 Participants
|
26 participants
n=4 Participants
|
109 participants
n=21 Participants
|
|
Weight
|
74.1 kilogram
STANDARD_DEVIATION 18.26 • n=5 Participants
|
68.2 kilogram
STANDARD_DEVIATION 14.17 • n=7 Participants
|
72.1 kilogram
STANDARD_DEVIATION 17.95 • n=5 Participants
|
67.2 kilogram
STANDARD_DEVIATION 13.86 • n=4 Participants
|
69.2 kilogram
STANDARD_DEVIATION 15.49 • n=21 Participants
|
|
Height
|
160.2 centimeters
STANDARD_DEVIATION 8.63 • n=5 Participants
|
159.5 centimeters
STANDARD_DEVIATION 8.11 • n=7 Participants
|
158.6 centimeters
STANDARD_DEVIATION 9.22 • n=5 Participants
|
158.0 centimeters
STANDARD_DEVIATION 7.44 • n=4 Participants
|
158.7 centimeters
STANDARD_DEVIATION 8.25 • n=21 Participants
|
|
Smoking Status
Current Smoker
|
6 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
12 participants
n=4 Participants
|
37 participants
n=21 Participants
|
|
Smoking Status
Never Smoked
|
38 participants
n=5 Participants
|
39 participants
n=7 Participants
|
36 participants
n=5 Participants
|
36 participants
n=4 Participants
|
149 participants
n=21 Participants
|
|
Smoking Status
Past Smoker
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
2 participants
n=4 Participants
|
15 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Intent-to-Treat (ITT) population, which is all patients who were randomized to a treatment group.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=51 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 20% (ACR20) Response Rate at Week 12
|
54.0 percentage of participants
Interval 39.3 to 68.2
|
45.1 percentage of participants
Interval 31.1 to 59.7
|
58.0 percentage of participants
Interval 43.2 to 71.8
|
60.0 percentage of participants
Interval 45.2 to 73.6
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 20% (ACR20) Response Rate at Week 1
|
46.0 percentage of participants
Interval 31.8 to 60.7
|
12.2 percentage of participants
Interval 4.6 to 24.8
|
20.8 percentage of participants
Interval 10.5 to 35.0
|
32.7 percentage of participants
Interval 19.9 to 47.5
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 20% (ACR20) Response Rate at Week 2
|
50.0 percentage of participants
Interval 35.5 to 64.5
|
18.4 percentage of participants
Interval 8.8 to 32.0
|
31.3 percentage of participants
Interval 18.7 to 46.3
|
32.7 percentage of participants
Interval 19.9 to 47.5
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 20% (ACR20) Response Rate at Week 4
|
58.0 percentage of participants
Interval 43.2 to 71.8
|
44.9 percentage of participants
Interval 30.7 to 59.8
|
54.2 percentage of participants
Interval 39.2 to 68.6
|
44.9 percentage of participants
Interval 30.7 to 59.8
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 20% (ACR20) Response Rate at Week 8
|
48.0 percentage of participants
Interval 33.7 to 62.6
|
49.0 percentage of participants
Interval 34.4 to 63.7
|
56.3 percentage of participants
Interval 41.2 to 70.5
|
53.1 percentage of participants
Interval 38.3 to 67.5
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up)
|
46.0 percentage of participants
Interval 31.8 to 60.7
|
40.8 percentage of participants
Interval 27.0 to 55.8
|
52.1 percentage of participants
Interval 37.2 to 66.7
|
49.0 percentage of participants
Interval 34.4 to 63.7
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 50% (ACR50) Response Rate at Week 1
|
4.0 percentage of participants
Interval 0.5 to 13.7
|
2.0 percentage of participants
Interval 0.1 to 10.9
|
6.3 percentage of participants
Interval 1.3 to 17.2
|
2.0 percentage of participants
Interval 0.1 to 10.9
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 50% (ACR50) Response Rate at Week 2
|
16.0 percentage of participants
Interval 7.2 to 29.1
|
6.1 percentage of participants
Interval 1.3 to 16.9
|
8.3 percentage of participants
Interval 2.3 to 20.0
|
10.2 percentage of participants
Interval 3.4 to 22.2
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 50% (ACR50) Response Rate at Week 4
|
16.0 percentage of participants
Interval 7.2 to 29.1
|
10.2 percentage of participants
Interval 3.4 to 22.2
|
8.3 percentage of participants
Interval 2.3 to 20.0
|
12.2 percentage of participants
Interval 4.6 to 24.8
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 50% (ACR50) Response Rate at Week 8
|
22.0 percentage of participants
Interval 11.5 to 36.0
|
16.3 percentage of participants
Interval 7.3 to 29.7
|
27.1 percentage of participants
Interval 15.3 to 41.8
|
16.3 percentage of participants
Interval 7.3 to 29.7
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 50% (ACR50) Response Rate at Week 12
|
22.0 percentage of participants
Interval 11.5 to 36.0
|
24.5 percentage of participants
Interval 13.3 to 38.9
|
25.0 percentage of participants
Interval 13.6 to 39.6
|
22.4 percentage of participants
Interval 11.8 to 36.6
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up)
|
14.0 percentage of participants
Interval 5.8 to 26.7
|
16.3 percentage of participants
Interval 7.3 to 29.7
|
27.1 percentage of participants
Interval 15.3 to 41.8
|
30.6 percentage of participants
Interval 18.3 to 45.4
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 70% (ACR70) Response Rate at Week 1
|
2.0 percentage of participants
Interval 0.1 to 10.6
|
0.0 percentage of participants
Interval 0.0 to 7.3
|
2.1 percentage of participants
Interval 0.1 to 11.1
|
0.0 percentage of participants
Interval 0.0 to 7.3
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 70% (ACR70) Response Rate at Week 2
|
2.0 percentage of participants
Interval 0.1 to 10.6
|
2.0 percentage of participants
Interval 0.1 to 10.9
|
4.2 percentage of participants
Interval 0.5 to 14.3
|
0.0 percentage of participants
Interval 0.0 to 7.3
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 70% (ACR70) Response Rate at Week 4
|
2.0 percentage of participants
Interval 0.1 to 10.6
|
0.0 percentage of participants
Interval 0.0 to 7.3
|
4.2 percentage of participants
Interval 0.5 to 14.3
|
2.0 percentage of participants
Interval 0.1 to 10.9
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 70% (ACR70) Response Rate at Week 8
|
4.0 percentage of participants
Interval 0.5 to 13.7
|
4.1 percentage of participants
Interval 0.5 to 14.0
|
4.2 percentage of participants
Interval 0.5 to 14.3
|
4.1 percentage of participants
Interval 0.5 to 14.0
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 70% (ACR70) Response Rate at Week 12
|
6.0 percentage of participants
Interval 1.3 to 16.5
|
8.2 percentage of participants
Interval 2.3 to 19.6
|
12.5 percentage of participants
Interval 4.7 to 25.2
|
8.2 percentage of participants
Interval 2.3 to 19.6
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up)
|
10.0 percentage of participants
Interval 3.3 to 21.8
|
6.1 percentage of participants
Interval 1.3 to 16.9
|
6.3 percentage of participants
Interval 1.3 to 17.2
|
6.1 percentage of participants
Interval 1.3 to 16.9
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
|
17.0 units on a scale
Standard Deviation 5.95
|
16.8 units on a scale
Standard Deviation 6.44
|
14.8 units on a scale
Standard Deviation 5.49
|
15.0 units on a scale
Standard Deviation 5.98
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
|
11.1 units on a scale
Standard Deviation 5.84
|
14.9 units on a scale
Standard Deviation 6.81
|
11.6 units on a scale
Standard Deviation 6.24
|
11.6 units on a scale
Standard Deviation 6.46
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
|
10.0 units on a scale
Standard Deviation 6.00
|
12.3 units on a scale
Standard Deviation 6.50
|
10.2 units on a scale
Standard Deviation 6.49
|
11.4 units on a scale
Standard Deviation 6.31
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
|
8.9 units on a scale
Standard Deviation 6.02
|
11.6 units on a scale
Standard Deviation 7.46
|
9.0 units on a scale
Standard Deviation 6.31
|
9.6 units on a scale
Standard Deviation 6.84
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
|
7.5 units on a scale
Standard Deviation 5.50
|
9.9 units on a scale
Standard Deviation 7.21
|
8.1 units on a scale
Standard Deviation 7.04
|
8.3 units on a scale
Standard Deviation 6.27
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
|
7.8 units on a scale
Standard Deviation 6.57
|
9.4 units on a scale
Standard Deviation 7.09
|
7.1 units on a scale
Standard Deviation 7.05
|
7.8 units on a scale
Standard Deviation 7.50
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
|
8.9 units on a scale
Standard Deviation 6.97
|
9.1 units on a scale
Standard Deviation 7.13
|
7.4 units on a scale
Standard Deviation 7.15
|
9.2 units on a scale
Standard Deviation 7.37
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
|
13.0 units on a scale
Standard Deviation 5.31
|
12.7 units on a scale
Standard Deviation 4.45
|
11.4 units on a scale
Standard Deviation 4.10
|
12.3 units on a scale
Standard Deviation 4.96
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
|
9.1 units on a scale
Standard Deviation 4.96
|
11.3 units on a scale
Standard Deviation 5.72
|
8.0 units on a scale
Standard Deviation 4.65
|
9.6 units on a scale
Standard Deviation 4.80
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
|
7.3 units on a scale
Standard Deviation 5.76
|
9.4 units on a scale
Standard Deviation 5.45
|
6.9 units on a scale
Standard Deviation 4.98
|
8.7 units on a scale
Standard Deviation 4.58
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
|
7.1 units on a scale
Standard Deviation 6.03
|
7.9 units on a scale
Standard Deviation 5.14
|
5.8 units on a scale
Standard Deviation 4.00
|
7.0 units on a scale
Standard Deviation 4.70
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
|
6.5 units on a scale
Standard Deviation 5.96
|
6.7 units on a scale
Standard Deviation 5.25
|
5.5 units on a scale
Standard Deviation 4.64
|
6.9 units on a scale
Standard Deviation 5.51
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
|
6.3 units on a scale
Standard Deviation 5.92
|
6.3 units on a scale
Standard Deviation 5.67
|
5.3 units on a scale
Standard Deviation 4.86
|
6.3 units on a scale
Standard Deviation 5.54
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
|
6.5 units on a scale
Standard Deviation 5.96
|
6.5 units on a scale
Standard Deviation 5.69
|
4.8 units on a scale
Standard Deviation 4.63
|
6.9 units on a scale
Standard Deviation 5.72
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
|
63.0 units on a scale
Standard Deviation 18.95
|
68.7 units on a scale
Standard Deviation 18.94
|
61.9 units on a scale
Standard Deviation 20.32
|
62.4 units on a scale
Standard Deviation 21.42
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
|
42.6 units on a scale
Standard Deviation 20.62
|
61.5 units on a scale
Standard Deviation 25.16
|
47.9 units on a scale
Standard Deviation 22.94
|
48.4 units on a scale
Standard Deviation 22.53
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
|
39.6 units on a scale
Standard Deviation 22.60
|
56.5 units on a scale
Standard Deviation 23.89
|
46.4 units on a scale
Standard Deviation 22.61
|
47.7 units on a scale
Standard Deviation 25.20
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
|
39.0 units on a scale
Standard Deviation 19.75
|
50.3 units on a scale
Standard Deviation 23.78
|
44.5 units on a scale
Standard Deviation 25.23
|
44.8 units on a scale
Standard Deviation 24.48
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
|
41.5 units on a scale
Standard Deviation 23.39
|
49.7 units on a scale
Standard Deviation 26.53
|
46.1 units on a scale
Standard Deviation 24.97
|
46.4 units on a scale
Standard Deviation 25.42
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
|
42.3 units on a scale
Standard Deviation 21.46
|
45.9 units on a scale
Standard Deviation 28.15
|
43.9 units on a scale
Standard Deviation 27.39
|
43.8 units on a scale
Standard Deviation 26.93
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
|
48.5 units on a scale
Standard Deviation 23.93
|
50.7 units on a scale
Standard Deviation 27.93
|
47.1 units on a scale
Standard Deviation 26.32
|
48.7 units on a scale
Standard Deviation 27.09
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
|
55.4 units on a scale
Standard Deviation 20.34
|
65.2 units on a scale
Standard Deviation 20.59
|
60.1 units on a scale
Standard Deviation 20.80
|
63.4 units on a scale
Standard Deviation 19.25
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
|
42.3 units on a scale
Standard Deviation 20.66
|
57.2 units on a scale
Standard Deviation 24.52
|
45.8 units on a scale
Standard Deviation 22.65
|
48.3 units on a scale
Standard Deviation 22.82
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
|
40.3 units on a scale
Standard Deviation 22.33
|
57.6 units on a scale
Standard Deviation 21.74
|
46.3 units on a scale
Standard Deviation 23.62
|
49.4 units on a scale
Standard Deviation 22.61
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
|
40.0 units on a scale
Standard Deviation 20.55
|
50.5 units on a scale
Standard Deviation 23.96
|
43.5 units on a scale
Standard Deviation 24.57
|
46.7 units on a scale
Standard Deviation 23.70
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
|
41.8 units on a scale
Standard Deviation 21.60
|
48.7 units on a scale
Standard Deviation 26.34
|
42.9 units on a scale
Standard Deviation 24.69
|
45.5 units on a scale
Standard Deviation 22.95
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
|
41.1 units on a scale
Standard Deviation 19.75
|
45.5 units on a scale
Standard Deviation 26.71
|
40.6 units on a scale
Standard Deviation 23.24
|
43.4 units on a scale
Standard Deviation 24.82
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
|
44.8 units on a scale
Standard Deviation 21.95
|
46.9 units on a scale
Standard Deviation 26.69
|
42.6 units on a scale
Standard Deviation 22.99
|
47.5 units on a scale
Standard Deviation 27.18
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
|
59.7 units on a scale
Standard Deviation 13.26
|
61.2 units on a scale
Standard Deviation 16.71
|
66.0 units on a scale
Standard Deviation 13.80
|
61.0 units on a scale
Standard Deviation 15.23
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
|
41.1 units on a scale
Standard Deviation 17.14
|
53.7 units on a scale
Standard Deviation 17.80
|
47.7 units on a scale
Standard Deviation 19.55
|
46.8 units on a scale
Standard Deviation 18.21
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
|
35.3 units on a scale
Standard Deviation 18.27
|
47.9 units on a scale
Standard Deviation 18.61
|
41.8 units on a scale
Standard Deviation 18.67
|
43.9 units on a scale
Standard Deviation 19.45
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
|
34.7 units on a scale
Standard Deviation 19.20
|
42.0 units on a scale
Standard Deviation 19.83
|
39.9 units on a scale
Standard Deviation 21.55
|
38.8 units on a scale
Standard Deviation 18.40
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
|
32.7 units on a scale
Standard Deviation 22.50
|
39.5 units on a scale
Standard Deviation 20.96
|
37.0 units on a scale
Standard Deviation 21.21
|
36.8 units on a scale
Standard Deviation 18.88
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
|
31.2 units on a scale
Standard Deviation 21.64
|
35.8 units on a scale
Standard Deviation 21.96
|
34.9 units on a scale
Standard Deviation 22.19
|
35.7 units on a scale
Standard Deviation 21.06
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
|
34.6 units on a scale
Standard Deviation 20.37
|
36.7 units on a scale
Standard Deviation 20.86
|
33.2 units on a scale
Standard Deviation 19.22
|
40.7 units on a scale
Standard Deviation 21.92
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
|
1.5 units on a scale
Standard Deviation 0.65
|
1.6 units on a scale
Standard Deviation 0.59
|
1.5 units on a scale
Standard Deviation 0.52
|
1.5 units on a scale
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
|
1.2 units on a scale
Standard Deviation 0.68
|
1.6 units on a scale
Standard Deviation 0.66
|
1.3 units on a scale
Standard Deviation 0.58
|
1.3 units on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
|
1.0 units on a scale
Standard Deviation 0.62
|
1.5 units on a scale
Standard Deviation 0.59
|
1.3 units on a scale
Standard Deviation 0.59
|
1.3 units on a scale
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
|
1.1 units on a scale
Standard Deviation 0.60
|
1.4 units on a scale
Standard Deviation 0.63
|
1.3 units on a scale
Standard Deviation 0.68
|
1.2 units on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
|
1.1 units on a scale
Standard Deviation 0.66
|
1.4 units on a scale
Standard Deviation 0.70
|
1.2 units on a scale
Standard Deviation 0.72
|
1.2 units on a scale
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
|
1.1 units on a scale
Standard Deviation 0.64
|
1.3 units on a scale
Standard Deviation 0.72
|
1.1 units on a scale
Standard Deviation 0.66
|
1.1 units on a scale
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
|
1.1 units on a scale
Standard Deviation 0.62
|
1.3 units on a scale
Standard Deviation 0.76
|
1.2 units on a scale
Standard Deviation 0.70
|
1.2 units on a scale
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
C-Reactive Protein (CRP) at Baseline
|
2.4 mg/dL
Standard Deviation 1.95
|
1.9 mg/dL
Standard Deviation 1.42
|
1.8 mg/dL
Standard Deviation 1.18
|
2.4 mg/dL
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
C-Reactive Protein (CRP) at Week 1
|
1.4 mg/dL
Standard Deviation 1.58
|
2.2 mg/dL
Standard Deviation 2.20
|
1.9 mg/dL
Standard Deviation 2.85
|
2.0 mg/dL
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
C-Reactive Protein (CRP) at Week 2
|
2.1 mg/dL
Standard Deviation 2.07
|
1.9 mg/dL
Standard Deviation 1.70
|
1.9 mg/dL
Standard Deviation 1.70
|
2.5 mg/dL
Standard Deviation 2.36
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
C-Reactive Protein (CRP) at Week 4
|
2.2 mg/dL
Standard Deviation 2.25
|
1.9 mg/dL
Standard Deviation 1.55
|
2.2 mg/dL
Standard Deviation 3.18
|
2.6 mg/dL
Standard Deviation 3.02
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
C-Reactive Protein (CRP) at Week 8
|
3.0 mg/dL
Standard Deviation 3.34
|
2.1 mg/dL
Standard Deviation 2.24
|
2.0 mg/dL
Standard Deviation 1.88
|
2.6 mg/dL
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
C-Reactive Protein (CRP) at Week 12
|
2.9 mg/dL
Standard Deviation 2.91
|
2.1 mg/dL
Standard Deviation 2.14
|
1.8 mg/dL
Standard Deviation 1.87
|
2.5 mg/dL
Standard Deviation 2.51
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
C-Reactive Protein (CRP) at Week 16 (Follow-up)
|
2.3 mg/dL
Standard Deviation 2.50
|
1.9 mg/dL
Standard Deviation 1.79
|
2.3 mg/dL
Standard Deviation 3.33
|
2.0 mg/dL
Standard Deviation 1.68
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
|
6.1 units on a scale
Standard Deviation 0.77
|
6.1 units on a scale
Standard Deviation 0.77
|
5.9 units on a scale
Standard Deviation 0.61
|
6.0 units on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
|
5.0 units on a scale
Standard Deviation 0.97
|
5.8 units on a scale
Standard Deviation 1.01
|
5.0 units on a scale
Standard Deviation 1.03
|
5.2 units on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
|
4.8 units on a scale
Standard Deviation 1.14
|
5.4 units on a scale
Standard Deviation 0.94
|
4.9 units on a scale
Standard Deviation 1.17
|
5.3 units on a scale
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
|
4.7 units on a scale
Standard Deviation 1.24
|
5.2 units on a scale
Standard Deviation 1.13
|
4.7 units on a scale
Standard Deviation 1.28
|
5.0 units on a scale
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
|
4.6 units on a scale
Standard Deviation 1.40
|
4.9 units on a scale
Standard Deviation 1.23
|
4.6 units on a scale
Standard Deviation 1.34
|
4.8 units on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
|
4.6 units on a scale
Standard Deviation 1.43
|
4.8 units on a scale
Standard Deviation 1.26
|
4.3 units on a scale
Standard Deviation 1.39
|
4.6 units on a scale
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
|
4.7 units on a scale
Standard Deviation 1.42
|
4.8 units on a scale
Standard Deviation 1.20
|
4.4 units on a scale
Standard Deviation 1.27
|
4.8 units on a scale
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
|
33.8 units on a scale
Standard Deviation 9.58
|
29.8 units on a scale
Standard Deviation 8.45
|
31.4 units on a scale
Standard Deviation 7.78
|
31.6 units on a scale
Standard Deviation 8.29
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
|
38.7 units on a scale
Standard Deviation 8.74
|
33.8 units on a scale
Standard Deviation 9.05
|
36.0 units on a scale
Standard Deviation 9.10
|
34.3 units on a scale
Standard Deviation 9.73
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
|
38.2 units on a scale
Standard Deviation 10.36
|
34.2 units on a scale
Standard Deviation 9.86
|
37.2 units on a scale
Standard Deviation 9.25
|
34.9 units on a scale
Standard Deviation 10.32
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
|
38.8 units on a scale
Standard Deviation 9.63
|
34.5 units on a scale
Standard Deviation 11.08
|
37.2 units on a scale
Standard Deviation 9.83
|
36.4 units on a scale
Standard Deviation 10.91
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
|
37.8 units on a scale
Standard Deviation 9.84
|
35.4 units on a scale
Standard Deviation 11.10
|
36.0 units on a scale
Standard Deviation 9.75
|
35.5 units on a scale
Standard Deviation 8.99
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
|
32.9 units on a scale
Standard Deviation 8.49
|
30.3 units on a scale
Standard Deviation 8.47
|
32.7 units on a scale
Standard Deviation 8.07
|
32.3 units on a scale
Standard Deviation 7.68
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
|
38.6 units on a scale
Standard Deviation 7.88
|
34.8 units on a scale
Standard Deviation 8.20
|
37.1 units on a scale
Standard Deviation 9.69
|
37.1 units on a scale
Standard Deviation 7.89
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
|
39.2 units on a scale
Standard Deviation 9.20
|
34.6 units on a scale
Standard Deviation 9.17
|
39.2 units on a scale
Standard Deviation 9.70
|
36.5 units on a scale
Standard Deviation 8.09
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
|
39.3 units on a scale
Standard Deviation 8.12
|
35.1 units on a scale
Standard Deviation 9.65
|
39.7 units on a scale
Standard Deviation 10.36
|
37.9 units on a scale
Standard Deviation 9.46
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
|
38.7 units on a scale
Standard Deviation 9.21
|
36.4 units on a scale
Standard Deviation 10.45
|
38.9 units on a scale
Standard Deviation 8.50
|
36.9 units on a scale
Standard Deviation 9.48
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
|
33.0 units on a scale
Standard Deviation 6.50
|
32.5 units on a scale
Standard Deviation 6.39
|
33.1 units on a scale
Standard Deviation 6.22
|
32.4 units on a scale
Standard Deviation 7.18
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
|
41.0 units on a scale
Standard Deviation 9.22
|
37.3 units on a scale
Standard Deviation 8.49
|
38.1 units on a scale
Standard Deviation 9.22
|
38.0 units on a scale
Standard Deviation 8.58
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
|
40.8 units on a scale
Standard Deviation 10.11
|
37.2 units on a scale
Standard Deviation 9.05
|
39.1 units on a scale
Standard Deviation 9.73
|
38.7 units on a scale
Standard Deviation 8.27
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
|
40.9 units on a scale
Standard Deviation 9.62
|
38.1 units on a scale
Standard Deviation 10.01
|
39.3 units on a scale
Standard Deviation 9.21
|
38.7 units on a scale
Standard Deviation 9.61
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
|
38.1 units on a scale
Standard Deviation 9.19
|
37.9 units on a scale
Standard Deviation 10.62
|
38.1 units on a scale
Standard Deviation 9.89
|
37.0 units on a scale
Standard Deviation 9.73
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
|
36.1 units on a scale
Standard Deviation 7.44
|
34.1 units on a scale
Standard Deviation 6.65
|
33.6 units on a scale
Standard Deviation 8.05
|
34.0 units on a scale
Standard Deviation 7.85
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
|
38.9 units on a scale
Standard Deviation 9.07
|
36.4 units on a scale
Standard Deviation 6.00
|
36.9 units on a scale
Standard Deviation 9.10
|
36.9 units on a scale
Standard Deviation 9.11
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
|
39.7 units on a scale
Standard Deviation 9.29
|
36.8 units on a scale
Standard Deviation 7.96
|
37.8 units on a scale
Standard Deviation 9.10
|
36.9 units on a scale
Standard Deviation 8.21
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
|
39.2 units on a scale
Standard Deviation 8.74
|
37.8 units on a scale
Standard Deviation 6.93
|
37.1 units on a scale
Standard Deviation 9.13
|
36.7 units on a scale
Standard Deviation 9.28
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
|
38.3 units on a scale
Standard Deviation 9.25
|
37.4 units on a scale
Standard Deviation 8.60
|
36.8 units on a scale
Standard Deviation 9.02
|
36.4 units on a scale
Standard Deviation 8.53
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
|
44.5 units on a scale
Standard Deviation 8.30
|
40.1 units on a scale
Standard Deviation 10.10
|
41.5 units on a scale
Standard Deviation 7.79
|
41.3 units on a scale
Standard Deviation 9.17
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
|
47.3 units on a scale
Standard Deviation 9.64
|
44.3 units on a scale
Standard Deviation 8.75
|
46.3 units on a scale
Standard Deviation 10.31
|
44.7 units on a scale
Standard Deviation 9.16
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
|
49.0 units on a scale
Standard Deviation 9.30
|
43.9 units on a scale
Standard Deviation 9.76
|
47.2 units on a scale
Standard Deviation 11.08
|
45.3 units on a scale
Standard Deviation 10.03
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
|
47.5 units on a scale
Standard Deviation 9.41
|
45.5 units on a scale
Standard Deviation 9.73
|
47.8 units on a scale
Standard Deviation 10.20
|
46.3 units on a scale
Standard Deviation 10.56
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
|
46.9 units on a scale
Standard Deviation 9.93
|
45.1 units on a scale
Standard Deviation 10.55
|
47.4 units on a scale
Standard Deviation 11.67
|
44.4 units on a scale
Standard Deviation 9.91
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
|
36.7 units on a scale
Standard Deviation 10.62
|
32.7 units on a scale
Standard Deviation 10.97
|
34.1 units on a scale
Standard Deviation 9.28
|
34.7 units on a scale
Standard Deviation 9.50
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
|
38.9 units on a scale
Standard Deviation 9.71
|
36.9 units on a scale
Standard Deviation 9.74
|
39.9 units on a scale
Standard Deviation 10.07
|
38.3 units on a scale
Standard Deviation 10.04
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
|
40.2 units on a scale
Standard Deviation 9.44
|
37.1 units on a scale
Standard Deviation 10.41
|
40.0 units on a scale
Standard Deviation 9.60
|
39.0 units on a scale
Standard Deviation 10.09
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
|
39.6 units on a scale
Standard Deviation 8.67
|
37.3 units on a scale
Standard Deviation 10.93
|
38.9 units on a scale
Standard Deviation 10.01
|
40.2 units on a scale
Standard Deviation 10.15
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
|
38.8 units on a scale
Standard Deviation 10.70
|
37.1 units on a scale
Standard Deviation 11.97
|
39.0 units on a scale
Standard Deviation 10.77
|
37.2 units on a scale
Standard Deviation 10.18
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
|
32.7 units on a scale
Standard Deviation 13.03
|
29.3 units on a scale
Standard Deviation 12.17
|
31.2 units on a scale
Standard Deviation 11.66
|
31.1 units on a scale
Standard Deviation 9.96
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
|
34.6 units on a scale
Standard Deviation 10.96
|
34.8 units on a scale
Standard Deviation 10.88
|
36.2 units on a scale
Standard Deviation 12.69
|
34.1 units on a scale
Standard Deviation 10.32
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
|
36.5 units on a scale
Standard Deviation 10.91
|
33.3 units on a scale
Standard Deviation 12.19
|
38.3 units on a scale
Standard Deviation 11.79
|
34.5 units on a scale
Standard Deviation 11.09
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
|
36.5 units on a scale
Standard Deviation 11.17
|
33.4 units on a scale
Standard Deviation 12.14
|
37.4 units on a scale
Standard Deviation 12.38
|
35.0 units on a scale
Standard Deviation 11.46
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
|
36.1 units on a scale
Standard Deviation 12.46
|
34.4 units on a scale
Standard Deviation 13.11
|
36.4 units on a scale
Standard Deviation 10.77
|
35.2 units on a scale
Standard Deviation 10.73
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
|
38.9 units on a scale
Standard Deviation 12.06
|
35.3 units on a scale
Standard Deviation 12.54
|
37.4 units on a scale
Standard Deviation 10.99
|
36.1 units on a scale
Standard Deviation 11.39
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
|
40.9 units on a scale
Standard Deviation 10.80
|
40.6 units on a scale
Standard Deviation 11.13
|
43.3 units on a scale
Standard Deviation 12.95
|
38.9 units on a scale
Standard Deviation 12.64
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
|
42.7 units on a scale
Standard Deviation 11.43
|
40.5 units on a scale
Standard Deviation 11.70
|
42.9 units on a scale
Standard Deviation 12.44
|
39.7 units on a scale
Standard Deviation 12.63
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
|
41.7 units on a scale
Standard Deviation 11.66
|
41.0 units on a scale
Standard Deviation 11.23
|
43.1 units on a scale
Standard Deviation 11.58
|
39.7 units on a scale
Standard Deviation 12.14
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
|
40.4 units on a scale
Standard Deviation 12.11
|
40.5 units on a scale
Standard Deviation 12.27
|
41.4 units on a scale
Standard Deviation 13.00
|
37.7 units on a scale
Standard Deviation 11.70
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
SF-36V2 is a generic 36-item generic health status measure covering 2 summary measures: physical component summary (PCS) and mental health component score (MCS); it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst) to 100 (best).
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
|
40.0 units on a scale
Standard Deviation 11.86
|
35.9 units on a scale
Standard Deviation 12.47
|
37.8 units on a scale
Standard Deviation 10.91
|
37.3 units on a scale
Standard Deviation 10.11
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
|
40.4 units on a scale
Standard Deviation 10.79
|
41.1 units on a scale
Standard Deviation 11.01
|
43.3 units on a scale
Standard Deviation 12.95
|
39.9 units on a scale
Standard Deviation 11.52
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
|
42.8 units on a scale
Standard Deviation 10.82
|
40.2 units on a scale
Standard Deviation 11.36
|
43.7 units on a scale
Standard Deviation 11.41
|
40.6 units on a scale
Standard Deviation 12.35
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
|
41.7 units on a scale
Standard Deviation 11.35
|
40.7 units on a scale
Standard Deviation 11.06
|
43.1 units on a scale
Standard Deviation 11.31
|
40.9 units on a scale
Standard Deviation 11.66
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
|
41.1 units on a scale
Standard Deviation 11.92
|
40.4 units on a scale
Standard Deviation 11.98
|
42.3 units on a scale
Standard Deviation 12.10
|
39.3 units on a scale
Standard Deviation 11.14
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
|
33.9 units on a scale
Standard Deviation 6.98
|
32.1 units on a scale
Standard Deviation 6.06
|
32.8 units on a scale
Standard Deviation 5.91
|
32.9 units on a scale
Standard Deviation 6.30
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
|
40.5 units on a scale
Standard Deviation 7.57
|
35.3 units on a scale
Standard Deviation 7.47
|
36.6 units on a scale
Standard Deviation 7.73
|
37.1 units on a scale
Standard Deviation 7.08
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
|
40.0 units on a scale
Standard Deviation 8.78
|
35.8 units on a scale
Standard Deviation 7.59
|
38.1 units on a scale
Standard Deviation 8.12
|
37.2 units on a scale
Standard Deviation 6.73
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
|
40.3 units on a scale
Standard Deviation 8.16
|
36.5 units on a scale
Standard Deviation 8.26
|
38.3 units on a scale
Standard Deviation 8.82
|
38.2 units on a scale
Standard Deviation 8.65
|
SECONDARY outcome
Timeframe: Week 16 (Follow-up)Population: Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Outcome measures
| Measure |
ARRY-438162: 20 mg Bid
n=50 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
Placebo
n=49 Participants
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=48 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=49 Participants
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
|
39.0 units on a scale
Standard Deviation 7.96
|
37.1 units on a scale
Standard Deviation 9.50
|
37.6 units on a scale
Standard Deviation 7.34
|
37.2 units on a scale
Standard Deviation 7.95
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
ARRY-438162: 10 mg Bid
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
ARRY-438162: 40 mg qd
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
ARRY-438162: 20 mg Bid
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=49 participants at risk
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=49 participants at risk
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=50 participants at risk
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 20 mg Bid
n=50 participants at risk
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
EROSIVE OESOPHAGITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
ABDOMINAL INJURY
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
CHEST INJURY
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Vascular disorders
THROMBOPHLEBITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
Other adverse events
| Measure |
Placebo
n=49 participants at risk
Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 10 mg Bid
n=49 participants at risk
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 40 mg qd
n=50 participants at risk
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
ARRY-438162: 20 mg Bid
n=50 participants at risk
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
10.2%
5/49 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
6.1%
3/49 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
30.0%
15/50 • Number of events 15 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
24.0%
12/50 • Number of events 12 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
12.0%
6/50 • Number of events 6 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
4.1%
2/49 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
6.0%
3/50 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
6.0%
3/50 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
6.0%
3/50 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.1%
2/49 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
6.0%
3/50 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
CHEILITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
EROSIVE OESOPHAGITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
TONGUE DISORDER
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
RASH
|
4.1%
2/49 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
14.0%
7/50 • Number of events 7 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
10.0%
5/50 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
10.0%
5/50 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
ROSACEA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.1%
2/49 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.1%
2/49 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
4.1%
2/49 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
LIVEDO RETICULARIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
ONYCHOCLASIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
PERIORBITAL OEDEMA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
PIGMENTATION DISORDER
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
PLANTAR ERYTHEMA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
PRURIGO
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
8.2%
4/49 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
8.2%
4/49 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
10.0%
5/50 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
BRONCHITIS
|
4.1%
2/49 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.1%
2/49 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
8.0%
4/50 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
FOLLICULITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
6.1%
3/49 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
RASH PUSTULAR
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
INFLUENZA
|
6.1%
3/49 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
ACUTE TONSILLITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
GENITAL HERPES
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
HELICOBACTER GASTRITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
HERPES SIMPLEX
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
NASOPHARYNGITIS
|
8.2%
4/49 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
PARONYCHIA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
PHARYNGOTONSILLITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
TRACHEITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
TRACHEOBRONCHITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
ASYMPTOMATIC BACTERIURIA
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
8.2%
4/49 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
10.0%
5/50 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
10.0%
5/50 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.1%
2/49 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Investigations
TRANSAMINASES INCREASED
|
4.1%
2/49 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Investigations
BLOOD PRESSURE SYSTOLIC ABNORMAL
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Investigations
ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
10.2%
5/49 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.1%
2/49 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
10.0%
5/50 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Investigations
OSTEOARTHRITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
General disorders
OEDEMA PERIPHERAL
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
6.0%
3/50 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
6.0%
3/50 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
General disorders
FACE OEDEMA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
General disorders
FATIGUE
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
General disorders
GENERALISED OEDEMA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
General disorders
PYREXIA
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
General disorders
THIRST
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
General disorders
ASTHENIA
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
6.0%
3/50 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
HYPOTONIA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
SOMNOLENCE
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Vascular disorders
HYPERTENSION
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.1%
2/49 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
6.0%
3/50 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Vascular disorders
PHLEBITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Vascular disorders
THROMBOPHLEBITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Vascular disorders
VASCULITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
LEFT VENTRICULAR HYPERTROPHY
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
TRICUSPID VALVE INCOMPETENCE
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Eye disorders
EYE SWELLING
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Eye disorders
SCOTOMA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC SINUSITIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT INFLAMMATION
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.1%
2/49 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
ABDOMINAL INJURY
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
CHEST INJURY
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
4.0%
2/50 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Metabolism and nutrition disorders
DYSLIPIDAEMIA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Renal and urinary disorders
URINARY BLADDER POLYP
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Renal and urinary disorders
HAEMATURIA
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Renal and urinary disorders
PROTEINURIA
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Renal and urinary disorders
RENAL COLIC
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Reproductive system and breast disorders
GENITAL DISCHARGE
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Reproductive system and breast disorders
HYPOMENORRHOEA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Blood and lymphatic system disorders
LYMPHOCYTOSIS
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Blood and lymphatic system disorders
SPONTANEOUS HAEMATOMA
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
2.0%
1/50 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
2.0%
1/49 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/49 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
0.00%
0/50 • Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of the sponsor's agreements with its investigators may vary. However, the sponsor does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e. data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER