Trial Outcomes & Findings for Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis (NCT NCT00716144)
NCT ID: NCT00716144
Last Updated: 2018-01-29
Results Overview
PASI75 success at Visit 6 was defined as number of participants who achieved at least 75% reduction in PASI scores at Visit 6 compared to Visit 2 (Baseline). The PASI score was determined through evaluation of body surface area (BSA) covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
176 participants
Primary outcome timeframe
Week 12 (Visit 6)
Results posted on
2018-01-29
Participant Flow
A total of 176 participants were randomized into the study. This study was conducted at 25 centers located in Ireland, the United Kingdom, the Netherlands, Germany, and Russia from 19 June 2006 to 18 May 2007.
All participants were screened (Visit 1) two weeks prior to randomization (Visit 2) in order to evaluate their eligibility for entry into the trial. At Visit 1, participants signed an informed consent, provided their medical histories, reported their concomitant medication usages, and were evaluated against the inclusion/exclusion criteria.
Participant milestones
| Measure |
Placebo
Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 0.5 mg
Eligible participants received R115866 softgel capsule 0.5 milligram (mg) orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 1.0 mg
Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 2.0 mg
Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
45
|
45
|
45
|
|
Overall Study
COMPLETED
|
32
|
38
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
12
|
12
|
Reasons for withdrawal
| Measure |
Placebo
Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 0.5 mg
Eligible participants received R115866 softgel capsule 0.5 milligram (mg) orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 1.0 mg
Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 2.0 mg
Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
1
|
2
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
2
|
|
Overall Study
Non-compliance
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
2
|
2
|
|
Overall Study
Intercurrent illness
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrew consent, allowed use of data
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse event: left foot pain
|
0
|
1
|
0
|
0
|
|
Overall Study
Clinical Depression
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo
n=41 Participants
Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 0.5 mg
n=45 Participants
Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 1.0 mg
n=45 Participants
Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 2.0 mg
n=45 Participants
Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.9 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
42.3 Years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
47.3 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
48.2 Years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
NA Years
STANDARD_DEVIATION NA • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
161 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
174 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
PRIMARY outcome
Timeframe: Week 12 (Visit 6)Population: Modified Intent-to-Treat (MITT) population. MITT population comprised of all randomized participants who took study medication and provided post-Visit 2 efficacy data (i.e., had one on-therapy follow-up visit).
PASI75 success at Visit 6 was defined as number of participants who achieved at least 75% reduction in PASI scores at Visit 6 compared to Visit 2 (Baseline). The PASI score was determined through evaluation of body surface area (BSA) covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.
Outcome measures
| Measure |
Placebo
n=41 Participants
Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 0.5 mg
n=45 Participants
Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 1.0 mg
n=45 Participants
Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 2.0 mg
n=45 Participants
Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
|---|---|---|---|---|
|
Psoriasis Area Severity Index (PASI)75 Success at Visit 6
|
4 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 1 to Week 20 (Visit 3 to Visit 8)Population: MITT population.
PASI50 success was defined as number of participants who achieved at least 50% reduction in PASI scores at each post baseline visit (Visit 3 to 8) compared to Visit 2 (Baseline). The PASI score was determined through evaluation of BSA covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.
Outcome measures
| Measure |
Placebo
n=41 Participants
Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 0.5 mg
n=45 Participants
Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 1.0 mg
n=45 Participants
Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 2.0 mg
n=45 Participants
Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
|---|---|---|---|---|
|
PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit
Visit 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit
Visit 4
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit
Visit 5
|
7 Participants
|
9 Participants
|
8 Participants
|
11 Participants
|
|
PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit
Visit 7
|
11 Participants
|
18 Participants
|
17 Participants
|
21 Participants
|
|
PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit
Visit 8
|
15 Participants
|
16 Participants
|
18 Participants
|
24 Participants
|
|
PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit
Visit 6
|
8 Participants
|
18 Participants
|
18 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Week 1 to Week 20 (Visit 3 to Visit 8)Population: MITT population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points; thus, the overall number of participants analyzed reflects everyone in the MITT Population.
The IGA was used to assess the overall severity of a participant's plaque psoriasis at a particular time point and the evaluation took into consideration the three individual characteristics of plaque psoriasis (scaling, plaque elevation, and erythema). The IGA was recorded using a scale that ranged from 0 (clear), 1 = almost clear, 2 = mild, 3 = moderate to 4 (severe) in whole-unit increments; higher scores indicating worse psoriasis. Investigators did not refer to previous evaluations when conducting the IGA assessment. At every study visit, the investigator evaluated each participant's plaque psoriasis and recorded the one integer grade that best described the average, overall severity of the condition. Investigators were trained not to refer to previous assessments of the IGA, and not to base the IGA scores on any component of the PASI. Individual body regions were not assessed (as in the PASI), but rather a global evaluation for each participant at each visit was determined.
Outcome measures
| Measure |
Placebo
n=41 Participants
Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 0.5 mg
n=45 Participants
Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 1.0 mg
n=45 Participants
Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 2.0 mg
n=45 Participants
Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
|---|---|---|---|---|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Almost clear; Visit 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Severe; Visit 3
|
6 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Clear; Visit 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Almost clear; Visit 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Mild; Visit 4
|
15 Participants
|
14 Participants
|
19 Participants
|
18 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Moderate; Visit 4
|
22 Participants
|
28 Participants
|
22 Participants
|
24 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Clear; Visit 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Almost clear; Visit 5
|
3 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Clear; Visit 6
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Almost clear; Visit 6
|
3 Participants
|
9 Participants
|
6 Participants
|
11 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Mild; Visit 6
|
18 Participants
|
24 Participants
|
20 Participants
|
22 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Moderate; Visit 6
|
17 Participants
|
12 Participants
|
18 Participants
|
9 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Severe; Visit 6
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Clear; Visit 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Almost clear; Visit 7
|
5 Participants
|
11 Participants
|
8 Participants
|
14 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Mild; Visit 7
|
15 Participants
|
19 Participants
|
16 Participants
|
14 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Moderate; Visit 7
|
13 Participants
|
8 Participants
|
11 Participants
|
8 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Severe; Visit 7
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Clear; Visit 8
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Almost clear; Visit 8
|
6 Participants
|
6 Participants
|
9 Participants
|
15 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Mild; Visit 8
|
15 Participants
|
21 Participants
|
10 Participants
|
10 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Moderate; Visit 8
|
10 Participants
|
10 Participants
|
12 Participants
|
8 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Severe; Visit 8
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Clear; Visit 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Mild; Visit 3
|
8 Participants
|
7 Participants
|
12 Participants
|
15 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Moderate; Visit 3
|
27 Participants
|
31 Participants
|
30 Participants
|
25 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Severe; Visit 4
|
4 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Mild; Visit 5
|
15 Participants
|
21 Participants
|
15 Participants
|
18 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Moderate; Visit 5
|
21 Participants
|
21 Participants
|
25 Participants
|
18 Participants
|
|
Investigator's Global Assessment (IGA) at Each Post Baseline Visit
Severe; Visit 5
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 1 to Week 20 (Visit 3 to Visit 8) except Week 12 (Visit 6)Population: MITT population.
PASI75 success was defined as number of participants who achieved at least 75% reduction in PASI scores at each post baseline visit (Visit 3 to Visit 8) except Visit 6. The PASI score was determined through evaluation of BSA covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.
Outcome measures
| Measure |
Placebo
n=41 Participants
Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 0.5 mg
n=45 Participants
Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 1.0 mg
n=45 Participants
Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 2.0 mg
n=45 Participants
Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
|---|---|---|---|---|
|
PASI75 at Each Post Baseline Visit Except Visit 6
Visit 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
PASI75 at Each Post Baseline Visit Except Visit 6
Visit 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
PASI75 at Each Post Baseline Visit Except Visit 6
Visit 5
|
4 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
|
PASI75 at Each Post Baseline Visit Except Visit 6
Visit 7
|
5 Participants
|
8 Participants
|
6 Participants
|
7 Participants
|
|
PASI75 at Each Post Baseline Visit Except Visit 6
Visit 8
|
6 Participants
|
7 Participants
|
10 Participants
|
13 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
R115866 0.5 mg
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
R115866 1.0 mg
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
R115866 2.0 mg
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=41 participants at risk
Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 0.5 mg
n=45 participants at risk
Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 1.0 mg
n=45 participants at risk
Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 2.0 mg
n=45 participants at risk
Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
2.2%
1/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.4%
1/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
Other adverse events
| Measure |
Placebo
n=41 participants at risk
Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 0.5 mg
n=45 participants at risk
Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 1.0 mg
n=45 participants at risk
Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
R115866 2.0 mg
n=45 participants at risk
Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Coagulopathy
|
4.9%
2/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
6.7%
3/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
2.2%
1/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
4.4%
2/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Eye disorders
Dry eye
|
2.4%
1/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
6.7%
3/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
13.3%
6/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
6.7%
3/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
22.2%
10/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
28.9%
13/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
15.6%
7/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Gastrointestinal disorders
Dry mouth
|
4.9%
2/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
4.4%
2/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
6.7%
3/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
2.2%
1/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Gastrointestinal disorders
Lip dry
|
2.4%
1/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
20.0%
9/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
17.8%
8/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
26.7%
12/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
1/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
11.1%
5/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
4.4%
2/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
2.2%
1/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Investigations
Blood cholesterol increased
|
2.4%
1/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
2.2%
1/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
6.7%
3/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
6.7%
3/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
6.7%
3/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
11.1%
5/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Investigations
Prothrombin time prolonged
|
7.3%
3/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
2.2%
1/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
2.2%
1/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
2.2%
1/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
2.2%
1/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
8.9%
4/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Psychiatric disorders
Depressive symptom
|
4.9%
2/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
6.7%
3/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
2.2%
1/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
4.4%
2/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
2.2%
1/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
6.7%
3/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
2.2%
1/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
2.2%
1/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
20.0%
9/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.2%
5/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
8.9%
4/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
17.8%
8/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
24.4%
11/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.2%
5/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
8.9%
4/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
4.4%
2/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
8.9%
4/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
7.3%
3/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
2.2%
1/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
6.7%
3/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
8.9%
4/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
4.4%
2/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
6.7%
3/45 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER