Trial Outcomes & Findings for A Dose Ranging Study to Evaluate the Safety and Efficacy of GSK2586184 in Patients With Chronic Plaque Psoriasis (NCT NCT01782664)
NCT ID: NCT01782664
Last Updated: 2017-08-03
Results Overview
PASI score was determined by evaluation of body surface area (BSA) covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 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, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. Percentage of participants who achieved \>= 75% improvement from Baseline was reported with last observation carried forward (LOCF) analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2017-08-03
Participant Flow
A total of 68 participants with chronic plaque psoriasis were enrolled. The study was conducted at 13 centers in 2 countries: 10 in Germany and 3 in United Kingdom from 12 March 2013 to 24 March 2014.
A total of 68 participants were enrolled for this study. Of these, 1 participant was not dosed any study medication because the participant was taking prohibited concomitant medications.
Participant milestones
| Measure |
Placebo
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
16
|
14
|
6
|
2
|
|
Overall Study
COMPLETED
|
8
|
10
|
12
|
9
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
4
|
5
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
2
|
2
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
2
|
2
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Dose Ranging Study to Evaluate the Safety and Efficacy of GSK2586184 in Patients With Chronic Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo
n=14 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.0 Years
STANDARD_DEVIATION 13.79 • n=5 Participants
|
43.9 Years
STANDARD_DEVIATION 14.10 • n=7 Participants
|
49.0 Years
STANDARD_DEVIATION 13.24 • n=5 Participants
|
41.5 Years
STANDARD_DEVIATION 12.08 • n=4 Participants
|
50.7 Years
STANDARD_DEVIATION 11.96 • n=21 Participants
|
53.5 Years
STANDARD_DEVIATION 2.12 • n=8 Participants
|
46.6 Years
STANDARD_DEVIATION 13.11 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
30 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
64 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent-to-Treat (ITT) Population: participants who received at least one dose of study medication.
PASI score was determined by evaluation of body surface area (BSA) covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 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, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. Percentage of participants who achieved \>= 75% improvement from Baseline was reported with last observation carried forward (LOCF) analysis.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)
|
0 Percentage of participants
|
13 Percentage of participants
|
25 Percentage of participants
|
57 Percentage of participants
|
50 Percentage of participants
|
50 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Per-Protocol Population: Participants in the ITT analysis set who had no major protocol deviations.
PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 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, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. Percentage of participants who achieved \>= 75% improvement from Baseline was reported with LOCF analysis.
Outcome measures
| Measure |
Placebo
n=11 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=14 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=11 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=13 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=4 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)
|
0 Percentage of participants
|
14 Percentage of participants
|
36 Percentage of participants
|
62 Percentage of participants
|
75 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until the Follow-up visit (Day 112)Population: ITT Population
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect. Any SAEs assessed as related to study participation (e.g. study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK product was recorded from the time a participant consents to participate in the study up to and including any follow-up contact.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any AE
|
13 Participants
|
10 Participants
|
14 Participants
|
10 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any SAE
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From BL (Day 1) until the Follow-up visit (Day 112)Population: ITT Population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Hematology parameters included: basophils, eosinophils, erythrocyte mean corpuscular hemoglobin (EMCHb) EMCHb concentration (EMCHbC), erythrocyte mean corpuscular volume (EMCV), erythrocyte sedimentation rate (ESR), erythrocytes, hematocrit (fraction 1), hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, segmented neutrophils, platelets, reticulocytes. BL values were obtained at Day 1. The number of participants with the indicated hematology parameters data outside of the reference range (with high and low) any time post-BL are presented. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Lymphocytes, low
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Eosinophils, low
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Eosinophils, high
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Hemoglobin, low
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Leukocytes, high
|
3 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Lymphocytes, high
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Monocytes, low
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Neutrophils, low
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Neutrophils, high
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Neutrophils, Segmented, low
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Reticulocytes, high
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Monocytes, high
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Neutrophils, Segmented, high
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Platelets, low
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Platelets, high
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Reticulocytes, low
|
3 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
EMCHbC, low
|
6 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
EMCHb, low
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
EMCHb, high
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
EMCV, low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
EMCV, high
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
ESR, high
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Erythrocytes, low
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Erythrocytes, high
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Hematocrit, low
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Hematocrit, high
|
5 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Hemoglobin, high
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study
Leukocytes, low
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until the Follow-up visit (Day 112)Population: ITT population. Only those participants available at the specified time points were analyzed.
Safety and tolerability were assessed by measuring the clinical chemistry parameters such as creatinine and cystatin C. BL values were obtained at Day 1. The number of participants with the indicated hematology parameter data outside of the reference range (\> high or \< low) at any time post-BL, including unscheduled or scheduled assessments, are presented.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the Study
Creatinine, high, n=13,15,16,14,6,2
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the Study
Cystatin C, high, n=13,15,16,14,6,2
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the Study
Cystatin C, low, n=13,15,16,14,6,2
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the Study
Creatinine, low, n=13,15,16,14,6,2
|
5 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until the follow-up visit (Day 112)Population: ITT Population. Only those participants available at the specified time points were analyzed.
Vital sign monitoring included systolic and diastolic BP measurements. BP measurements were taken in the supine position after 5 minutes of rest. The number of participants with the SBP or DBP outside the clinical concern range at any time post-BL are presented. SBP "low" was measured as less than 85 millimeters of mercury (mmHg)and "high" was measured as greater than 160 mmHg. DBP "low" was measured as less than 45 mmHg and "high" was measured as greater than 100 mmHg. The BL values were those values obtained at Day 1. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment.
Outcome measures
| Measure |
Placebo
n=13 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the Study
DBP, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the Study
SBP, high
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the Study
DBP, high
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until the Follow-up visit (Day 112)Population: ITT Population. Only those participants available at the specified time points were analyzed.
Vital sign monitoring included heart rate (HR) measurements. HR measurements were taken in supine position after 5 minutes of rest. The number of participants with HR outside the clinical concern range at any time post-BL are presented. HR "low" was any HR less than 40 beats per minute (bpm) and "high" was any HR greater than 110 bpm. The BL values were those values obtained at Day 1. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment.
Outcome measures
| Measure |
Placebo
n=13 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With the Heart Rate Falling Outside the Clinical Concern Range at Any Time Post-Baseline (BL) During the Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until Week 16Population: ITT Population. Only those participants available at the specified time points were analyzed.
Vital sign monitoring included body temperature measurements. Body temperature measurements were taken in the supine position after 5 minutes of rest. Baseline is defined as the last result on or before the day of first dose. Change from Baseline was determined by subtracting the indicated time point value minus the Baseline value.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Temperature
Week 8
|
0.1 Celsius
Standard Deviation 0.44
|
0.1 Celsius
Standard Deviation 0.51
|
-0.2 Celsius
Standard Deviation 0.55
|
-0.1 Celsius
Standard Deviation 0.28
|
0.2 Celsius
Standard Deviation 0.51
|
0.1 Celsius
Standard Deviation 0.21
|
|
Change From Baseline in Body Temperature
Week 12
|
-0.1 Celsius
Standard Deviation 0.38
|
-0.2 Celsius
Standard Deviation 0.64
|
-0.1 Celsius
Standard Deviation 0.38
|
-0.0 Celsius
Standard Deviation 0.23
|
0.0 Celsius
Standard Deviation 0.29
|
0.2 Celsius
Standard Deviation 0.00
|
|
Change From Baseline in Body Temperature
Week 16
|
0.3 Celsius
Standard Deviation 0.45
|
-0.1 Celsius
Standard Deviation 0.66
|
0.1 Celsius
Standard Deviation 0.39
|
-0.1 Celsius
Standard Deviation 0.21
|
0.4 Celsius
Standard Deviation 0.29
|
-0.0 Celsius
Standard Deviation 0.35
|
|
Change From Baseline in Body Temperature
Week 2
|
-0.2 Celsius
Standard Deviation 0.54
|
-0.0 Celsius
Standard Deviation 0.38
|
-0.1 Celsius
Standard Deviation 0.73
|
-0.0 Celsius
Standard Deviation 0.36
|
0.0 Celsius
Standard Deviation 0.21
|
0.6 Celsius
Standard Deviation 0.49
|
|
Change From Baseline in Body Temperature
Week 4
|
-0.1 Celsius
Standard Deviation 0.52
|
0.1 Celsius
Standard Deviation 0.44
|
-0.1 Celsius
Standard Deviation 0.53
|
0.0 Celsius
Standard Deviation 0.28
|
0.3 Celsius
Standard Deviation 0.37
|
0.0 Celsius
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until the Follow-up visit (Day 112)Population: ITT Population.
ECG measurements were obtained using single 12-lead ECGs with the participant in a supine position after resting in this position for at least 10 minutes. The Baseline values were those values obtained Pre-dose on Day 1. The change from Baseline was the difference between post-Baseline and Baseline. The QT intervals (milliseconds \[msec\]) corrected for heart rate using Bazett's formula (QTcB) and Fridericia's formula (QTcF) are reported.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) Findings
QTcF, <30 msec
|
13 Participants
|
15 Participants
|
16 Participants
|
12 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) Findings
QTcB, >=30 to <60 msec
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) Findings
QTcB, <30 msec
|
13 Participants
|
14 Participants
|
16 Participants
|
12 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) Findings
QTcF, >=30 to <60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until Week 12Population: ITT Population. Only those participants available at the specified time points were analyzed.
Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 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, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. The change from Baseline was the difference between post-Baseline and Baseline.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12
Week 4
|
-0.73 Scores on a Scale
Standard Deviation 3.335
|
-4.50 Scores on a Scale
Standard Deviation 4.344
|
-7.03 Scores on a Scale
Standard Deviation 7.594
|
-8.04 Scores on a Scale
Standard Deviation 7.739
|
-9.10 Scores on a Scale
Standard Deviation 3.854
|
-8.20 Scores on a Scale
Standard Deviation 0.990
|
|
Change From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12
Week 12
|
-3.13 Scores on a Scale
Standard Deviation 2.694
|
-9.76 Scores on a Scale
Standard Deviation 6.341
|
-9.21 Scores on a Scale
Standard Deviation 12.446
|
-13.55 Scores on a Scale
Standard Deviation 6.393
|
-9.37 Scores on a Scale
Standard Deviation 7.181
|
-12.45 Scores on a Scale
Standard Deviation 1.061
|
|
Change From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12
Week 2
|
-0.05 Scores on a Scale
Standard Deviation 1.716
|
-2.39 Scores on a Scale
Standard Deviation 3.120
|
-0.51 Scores on a Scale
Standard Deviation 7.693
|
-3.94 Scores on a Scale
Standard Deviation 4.766
|
-5.25 Scores on a Scale
Standard Deviation 4.192
|
-3.75 Scores on a Scale
Standard Deviation 2.192
|
|
Change From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12
Week 8
|
-1.41 Scores on a Scale
Standard Deviation 2.122
|
-6.54 Scores on a Scale
Standard Deviation 6.915
|
-8.45 Scores on a Scale
Standard Deviation 11.396
|
-10.32 Scores on a Scale
Standard Deviation 8.293
|
-7.85 Scores on a Scale
Standard Deviation 5.390
|
-11.50 Scores on a Scale
Standard Deviation 0.424
|
SECONDARY outcome
Timeframe: Week 2, 4, 8 and 12Population: ITT Population. Only those participants available at the specified time points were analyzed.
Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 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, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
PASI Score at Week 2, 4, 8 and 12
Week 4
|
15.12 Scores on a Scale
Standard Deviation 4.683
|
13.94 Scores on a Scale
Standard Deviation 6.616
|
12.59 Scores on a Scale
Standard Deviation 5.524
|
9.58 Scores on a Scale
Standard Deviation 7.910
|
9.90 Scores on a Scale
Standard Deviation 6.271
|
6.75 Scores on a Scale
Standard Deviation 1.485
|
|
PASI Score at Week 2, 4, 8 and 12
Week 2
|
16.33 Scores on a Scale
Standard Deviation 4.896
|
16.56 Scores on a Scale
Standard Deviation 5.708
|
18.92 Scores on a Scale
Standard Deviation 9.969
|
13.39 Scores on a Scale
Standard Deviation 5.594
|
13.75 Scores on a Scale
Standard Deviation 4.807
|
11.20 Scores on a Scale
Standard Deviation 0.283
|
|
PASI Score at Week 2, 4, 8 and 12
Week 8
|
14.64 Scores on a Scale
Standard Deviation 4.289
|
12.56 Scores on a Scale
Standard Deviation 5.442
|
11.03 Scores on a Scale
Standard Deviation 8.322
|
7.30 Scores on a Scale
Standard Deviation 9.110
|
11.15 Scores on a Scale
Standard Deviation 9.573
|
3.45 Scores on a Scale
Standard Deviation 2.899
|
|
PASI Score at Week 2, 4, 8 and 12
Week 12
|
12.92 Scores on a Scale
Standard Deviation 3.384
|
10.52 Scores on a Scale
Standard Deviation 4.932
|
9.67 Scores on a Scale
Standard Deviation 7.799
|
4.03 Scores on a Scale
Standard Deviation 4.666
|
9.63 Scores on a Scale
Standard Deviation 10.688
|
2.50 Scores on a Scale
Standard Deviation 3.536
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until Week 12Population: ITT Population.
Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 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, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline was Day 1.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12
PASI 50, Week 4
|
0 Percentage of Participants
|
13 Percentage of Participants
|
25 Percentage of Participants
|
57 Percentage of Participants
|
50 Percentage of Participants
|
100 Percentage of Participants
|
|
Percentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12
PASI 50, Week 8
|
0 Percentage of Participants
|
20 Percentage of Participants
|
31 Percentage of Participants
|
71 Percentage of Participants
|
50 Percentage of Participants
|
100 Percentage of Participants
|
|
Percentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12
PASI 75, Week 8
|
0 Percentage of Participants
|
7 Percentage of Participants
|
25 Percentage of Participants
|
50 Percentage of Participants
|
17 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12
PASI 90, Week 8
|
0 Percentage of Participants
|
7 Percentage of Participants
|
6 Percentage of Participants
|
14 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12
PASI 75, Week 12
|
0 Percentage of Participants
|
13 Percentage of Participants
|
25 Percentage of Participants
|
57 Percentage of Participants
|
50 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12
PASI 90, Week 12
|
0 Percentage of Participants
|
0 Percentage of Participants
|
25 Percentage of Participants
|
36 Percentage of Participants
|
17 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12
PASI 50, Week 2
|
0 Percentage of Participants
|
7 Percentage of Participants
|
6 Percentage of Participants
|
7 Percentage of Participants
|
17 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12
PASI 50, Week 12
|
0 Percentage of Participants
|
27 Percentage of Participants
|
31 Percentage of Participants
|
64 Percentage of Participants
|
50 Percentage of Participants
|
100 Percentage of Participants
|
|
Percentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12
PASI 75, Week 4
|
0 Percentage of Participants
|
7 Percentage of Participants
|
6 Percentage of Participants
|
21 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8 and 12Population: ITT Population
The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale), 4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). Higher scores indicated worse psoriasis. The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12
Week 2
|
0 Percentage of Participants
|
0 Percentage of Participants
|
6 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12
Week 12
|
0 Percentage of Participants
|
7 Percentage of Participants
|
25 Percentage of Participants
|
43 Percentage of Participants
|
17 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12
Week 4
|
0 Percentage of Participants
|
0 Percentage of Participants
|
6 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12
Week 8
|
0 Percentage of Participants
|
7 Percentage of Participants
|
6 Percentage of Participants
|
29 Percentage of Participants
|
0 Percentage of Participants
|
50 Percentage of Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8 and 12Population: ITT Population. Only those participants available at the specified time points were analyzed.
The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale), 4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). Higher scores indicated worse psoriasis. The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 2, severe
|
0 Percentage of Participants
|
7 Percentage of Participants
|
19 Percentage of Participants
|
7 Percentage of Participants
|
17 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 4, Clear
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 4, mild
|
0 Percentage of Participants
|
14 Percentage of Participants
|
0 Percentage of Participants
|
23 Percentage of Participants
|
33 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 4, almost clear
|
0 Percentage of Participants
|
0 Percentage of Participants
|
7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 2, Clear
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 2, almost clear
|
0 Percentage of Participants
|
0 Percentage of Participants
|
6 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 2, mild to moderate
|
23 Percentage of Participants
|
14 Percentage of Participants
|
19 Percentage of Participants
|
43 Percentage of Participants
|
33 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 4, mild to moderate
|
25 Percentage of Participants
|
36 Percentage of Participants
|
29 Percentage of Participants
|
54 Percentage of Participants
|
33 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 4, moderate
|
50 Percentage of Participants
|
29 Percentage of Participants
|
43 Percentage of Participants
|
8 Percentage of Participants
|
17 Percentage of Participants
|
100 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 4, severe
|
0 Percentage of Participants
|
7 Percentage of Participants
|
7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 8, Clear
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 8, almost clear
|
0 Percentage of Participants
|
9 Percentage of Participants
|
7 Percentage of Participants
|
31 Percentage of Participants
|
0 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 8, mild to moderate
|
22 Percentage of Participants
|
27 Percentage of Participants
|
20 Percentage of Participants
|
23 Percentage of Participants
|
17 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 8, moderate,
|
44 Percentage of Participants
|
36 Percentage of Participants
|
33 Percentage of Participants
|
8 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 8, moderate to severe
|
33 Percentage of Participants
|
9 Percentage of Participants
|
13 Percentage of Participants
|
8 Percentage of Participants
|
33 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 8, severe
|
0 Percentage of Participants
|
9 Percentage of Participants
|
7 Percentage of Participants
|
8 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 12, Clear
|
0 Percentage of Participants
|
0 Percentage of Participants
|
7 Percentage of Participants
|
30 Percentage of Participants
|
0 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 12, almost clear
|
0 Percentage of Participants
|
10 Percentage of Participants
|
21 Percentage of Participants
|
20 Percentage of Participants
|
17 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 12, mild
|
10 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
20 Percentage of Participants
|
17 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 12, mild to moderate
|
30 Percentage of Participants
|
50 Percentage of Participants
|
29 Percentage of Participants
|
20 Percentage of Participants
|
33 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 12, moderate
|
50 Percentage of Participants
|
30 Percentage of Participants
|
21 Percentage of Participants
|
0 Percentage of Participants
|
17 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 12, moderate to severe
|
10 Percentage of Participants
|
10 Percentage of Participants
|
21 Percentage of Participants
|
0 Percentage of Participants
|
17 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 12, Severe
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
10 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 2, moderate to severe
|
31 Percentage of Participants
|
14 Percentage of Participants
|
13 Percentage of Participants
|
14 Percentage of Participants
|
0 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 2, mild
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 4, moderate to severe
|
25 Percentage of Participants
|
14 Percentage of Participants
|
14 Percentage of Participants
|
15 Percentage of Participants
|
17 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 2, moderate
|
46 Percentage of Participants
|
64 Percentage of Participants
|
44 Percentage of Participants
|
36 Percentage of Participants
|
50 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12
Week 8, mild
|
0 Percentage of Participants
|
9 Percentage of Participants
|
20 Percentage of Participants
|
23 Percentage of Participants
|
50 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until Week 12Population: ITT Population. Only participants achieving PASI 75 were analyzed.
PASI 75 was \>= 75% improvement from Baseline in PASI score. Psoriatic lesions were assessed by the investigator using a PASI score. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 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, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline was Day 1.
Outcome measures
| Measure |
Placebo
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=2 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=4 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=9 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=3 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=1 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Time to PASI 75
|
—
|
59 Days
Interval 33.0 to 85.0
|
55.5 Days
Interval 29.0 to 63.0
|
57 Days
Interval 27.0 to 85.0
|
84 Days
Interval 56.0 to 85.0
|
57 Days
Interval 57.0 to 57.0
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until Week 12Population: ITT Population. Only participants achieving a PGA score of 'Clear' or 'Almost Clear' were analyzed.
The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale)4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.
Outcome measures
| Measure |
Placebo
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=1 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=4 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=6 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=1 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=1 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Time to PGA Score of 'Clear' (0) or 'Almost Clear' (1)
|
—
|
55 Days
Interval 55.0 to 55.0
|
84.5 Days
Interval 15.0 to 85.0
|
57 Days
Interval 55.0 to 87.0
|
84 Days
Interval 84.0 to 84.0
|
57 Days
Interval 57.0 to 57.0
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until Week 12Population: ITT Population. Only those participants available at the specified time points were analyzed.
The visual analogue scale (VAS) was used to assess itch. The participants rated the intensity of itch over the past week by marking a line on a 100 millimeter(mm) (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no noticeable itching sensation and extreme right that is 100 mm indicated maximum itching sensation. This scale has no subscales. The participant perception of their symptoms was measured using the VAS itch score. The Baseline value was the value obtained on Day 1. The change from Baseline was the difference between post-Baseline and Baseline.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12
Week 2
|
-5.67 Scores on a Scale
Standard Deviation 32.129
|
-14.79 Scores on a Scale
Standard Deviation 31.396
|
-14.87 Scores on a Scale
Standard Deviation 23.670
|
-24.92 Scores on a Scale
Standard Deviation 24.737
|
-56.33 Scores on a Scale
Standard Deviation 30.329
|
-22.00 Scores on a Scale
Standard Deviation 43.841
|
|
Change From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12
Week 4
|
-7.00 Scores on a Scale
Standard Deviation 37.944
|
-26.50 Scores on a Scale
Standard Deviation 28.659
|
-22.36 Scores on a Scale
Standard Deviation 27.244
|
-28.08 Scores on a Scale
Standard Deviation 25.678
|
-47.50 Scores on a Scale
Standard Deviation 39.480
|
-30.00 Scores on a Scale
Standard Deviation 62.225
|
|
Change From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12
Week 8
|
0.22 Scores on a Scale
Standard Deviation 26.138
|
-26.27 Scores on a Scale
Standard Deviation 35.707
|
-24.86 Scores on a Scale
Standard Deviation 37.134
|
-36.30 Scores on a Scale
Standard Deviation 29.788
|
-61.50 Scores on a Scale
Standard Deviation 31.729
|
-32.50 Scores on a Scale
Standard Deviation 65.761
|
|
Change From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12
Week 12
|
-1.56 Scores on a Scale
Standard Deviation 34.348
|
-21.40 Scores on a Scale
Standard Deviation 40.533
|
-23.92 Scores on a Scale
Standard Deviation 40.586
|
-41.13 Scores on a Scale
Standard Deviation 31.791
|
-60.80 Scores on a Scale
Standard Deviation 38.160
|
-25.00 Scores on a Scale
Standard Deviation 76.368
|
SECONDARY outcome
Timeframe: Week 2, 4, 8 and 12Population: ITT Population. Only those participants available at the specified time points were analyzed.
The visual analogue scale (VAS) was used to assess itch. The participants rated the intensity of itch over the past week by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no noticeable itching sensation and extreme right that is 100 mm indicated maximum itching sensation. This scale has no subscales. The participant perception of their symptoms was measured using the VAS itch score. Itch VAS scores at Week 2, 4, 8 and 12 are reported.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Itch VAS Scores at Week 2, 4, 8 and 12
Week 2,n=12,14,15,12,6,2
|
46.42 Scores on a Scale
Standard Deviation 28.909
|
41.64 Scores on a Scale
Standard Deviation 21.995
|
42.07 Scores on a Scale
Standard Deviation 31.176
|
22.92 Scores on a Scale
Standard Deviation 21.707
|
11.83 Scores on a Scale
Standard Deviation 14.730
|
42.00 Scores on a Scale
Standard Deviation 22.627
|
|
Itch VAS Scores at Week 2, 4, 8 and 12
Week 4,n=10,12,14,13,6,2
|
44.40 Scores on a Scale
Standard Deviation 35.485
|
33.42 Scores on a Scale
Standard Deviation 25.939
|
32.57 Scores on a Scale
Standard Deviation 30.729
|
23.85 Scores on a Scale
Standard Deviation 23.140
|
20.67 Scores on a Scale
Standard Deviation 30.051
|
34.00 Scores on a Scale
Standard Deviation 41.012
|
|
Itch VAS Scores at Week 2, 4, 8 and 12
Week 8,n=9,11,14,11,6,2
|
57.33 Scores on a Scale
Standard Deviation 29.368
|
31.55 Scores on a Scale
Standard Deviation 29.156
|
29.93 Scores on a Scale
Standard Deviation 29.437
|
14.45 Scores on a Scale
Standard Deviation 21.920
|
6.67 Scores on a Scale
Standard Deviation 7.763
|
31.50 Scores on a Scale
Standard Deviation 44.548
|
|
Itch VAS Scores at Week 2, 4, 8 and 12
Week 12,n=9,10,13,9,5,2
|
50.67 Scores on a Scale
Standard Deviation 37.683
|
39.50 Scores on a Scale
Standard Deviation 33.580
|
30.08 Scores on a Scale
Standard Deviation 34.697
|
14.00 Scores on a Scale
Standard Deviation 23.701
|
5.40 Scores on a Scale
Standard Deviation 6.693
|
39.00 Scores on a Scale
Standard Deviation 55.154
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT Population. Only those participants who had a Week 12 evaluation were analyzed.
The DLQI was used to assess a participant's health-related quality of life. Participants completed the questionnaire to evaluate how their psoriasis affected their life over the week before the assessment took place. Each of the 10 questions was scored out of 0-3 as; 0 = Not at all, 1 = A little, 2 = A lot and 3 = Very much. The total score for the DLQI was calculated by adding up all the individual scores for each question resulting in a minimum of 0 and a maximum of 30. Higher score indicated worsening of participant's quality of life. The Baseline value was the value obtained on Day 1. The change from Baseline was the difference between post-Baseline and Baseline.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=10 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=14 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=10 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=4 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline of Dermatology Life Quality Index (DLQI) Score at Week 12
|
1.70 Scores on a Scale
Standard Deviation 5.638
|
-2.80 Scores on a Scale
Standard Deviation 7.743
|
-4.29 Scores on a Scale
Standard Deviation 8.389
|
-8.00 Scores on a Scale
Standard Deviation 3.830
|
-6.75 Scores on a Scale
Standard Deviation 5.123
|
-8.00 Scores on a Scale
Standard Deviation 11.314
|
SECONDARY outcome
Timeframe: Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)Population: PK population. The PK Population comprised of all participants who were randomized and received at least one dose of study medication.
Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.
Outcome measures
| Measure |
Placebo
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=15 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Population Pharmacokinetic (PK) Derived Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Measureable Concentration (AUC(0-tau) of GSK2586184
|
—
|
1464.07903 Nanogram/milliLitre*hour (ng/mL*hr)
Geometric Coefficient of Variation 43.9
|
3516.96224 Nanogram/milliLitre*hour (ng/mL*hr)
Geometric Coefficient of Variation 38.7
|
7768.40786 Nanogram/milliLitre*hour (ng/mL*hr)
Geometric Coefficient of Variation 62.4
|
7561.87974 Nanogram/milliLitre*hour (ng/mL*hr)
Geometric Coefficient of Variation 79.1
|
3208.20452 Nanogram/milliLitre*hour (ng/mL*hr)
Geometric Coefficient of Variation 53.5
|
SECONDARY outcome
Timeframe: Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)Population: PK Population.
Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.
Outcome measures
| Measure |
Placebo
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=15 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Clearance of GSK2586184
|
—
|
68.30232 Litre (L)/hr
Geometric Coefficient of Variation 43.9
|
56.86726 Litre (L)/hr
Geometric Coefficient of Variation 38.7
|
51.49060 Litre (L)/hr
Geometric Coefficient of Variation 62.4
|
52.89690 Litre (L)/hr
Geometric Coefficient of Variation 79.1
|
62.34017 Litre (L)/hr
Geometric Coefficient of Variation 53.5
|
SECONDARY outcome
Timeframe: Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)Population: PK Population
Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.
Outcome measures
| Measure |
Placebo
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=15 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Steady State Volume of Distribution (Vss) of GSK2586184
|
—
|
244.10260 L
Geometric Coefficient of Variation 62.3
|
193.75344 L
Geometric Coefficient of Variation 47.1
|
186.78323 L
Geometric Coefficient of Variation 64.4
|
199.73746 L
Geometric Coefficient of Variation 85.4
|
216.00359 L
Geometric Coefficient of Variation 66.5
|
SECONDARY outcome
Timeframe: Baseline (pre-dose) and Weeks 2, 4, 8 and 12Population: ITT Population
Serum Neopterin is a marker of psoriatic disease activity. Blood samples were collected for estimation of serum neoprotein concentration. Baseline was Day 1. The change from Baseline was the difference between post-Baseline and Baseline.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 Participants
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 Participants
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 Participants
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 Participants
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 Participants
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12
Week 2
|
0.19 Nanomol per Liter (nmol/L)
Standard Deviation 1.219
|
0.43 Nanomol per Liter (nmol/L)
Standard Deviation 5.394
|
2.35 Nanomol per Liter (nmol/L)
Standard Deviation 6.475
|
-0.42 Nanomol per Liter (nmol/L)
Standard Deviation 1.858
|
-0.47 Nanomol per Liter (nmol/L)
Standard Deviation 0.918
|
9.95 Nanomol per Liter (nmol/L)
Standard Deviation 13.930
|
|
Change From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12
Week 4
|
0.18 Nanomol per Liter (nmol/L)
Standard Deviation 0.844
|
-1.69 Nanomol per Liter (nmol/L)
Standard Deviation 2.933
|
-1.15 Nanomol per Liter (nmol/L)
Standard Deviation 1.768
|
-0.69 Nanomol per Liter (nmol/L)
Standard Deviation 1.195
|
-0.67 Nanomol per Liter (nmol/L)
Standard Deviation 0.378
|
1.80 Nanomol per Liter (nmol/L)
Standard Deviation 2.828
|
|
Change From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12
Week 8
|
-0.14 Nanomol per Liter (nmol/L)
Standard Deviation 0.597
|
-1.13 Nanomol per Liter (nmol/L)
Standard Deviation 2.312
|
-0.81 Nanomol per Liter (nmol/L)
Standard Deviation 2.294
|
0.31 Nanomol per Liter (nmol/L)
Standard Deviation 2.998
|
-0.40 Nanomol per Liter (nmol/L)
Standard Deviation 1.520
|
0.15 Nanomol per Liter (nmol/L)
Standard Deviation 2.192
|
|
Change From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12
Week 12
|
-0.01 Nanomol per Liter (nmol/L)
Standard Deviation 1.038
|
-1.32 Nanomol per Liter (nmol/L)
Standard Deviation 2.355
|
-0.79 Nanomol per Liter (nmol/L)
Standard Deviation 1.738
|
4.37 Nanomol per Liter (nmol/L)
Standard Deviation 13.387
|
-0.42 Nanomol per Liter (nmol/L)
Standard Deviation 1.182
|
0.35 Nanomol per Liter (nmol/L)
Standard Deviation 0.212
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
GSK2586184 100 mg
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
GSK2586184 200 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
GSK2586184 400 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
GSK2586184 400 mg OL
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
GSK2586184 200 mg OL
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=14 participants at risk
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 participants at risk
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 participants at risk
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 participants at risk
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 participants at risk
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 participants at risk
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.7%
1/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.7%
1/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.7%
1/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
16.7%
1/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
Other adverse events
| Measure |
Placebo
n=14 participants at risk
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
|
GSK2586184 100 mg
n=15 participants at risk
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg
n=16 participants at risk
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg
n=14 participants at risk
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 400 mg OL
n=6 participants at risk
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
GSK2586184 200 mg OL
n=2 participants at risk
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
21.4%
3/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
33.3%
5/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
25.0%
4/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
35.7%
5/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
16.7%
1/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Cystitis
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.7%
1/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
16.7%
1/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Acne pustular
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
16.7%
1/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
16.7%
1/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Post procedural infection
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.7%
1/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Tinea pedis
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Immune system disorders
Tooth abscess
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
35.7%
5/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
33.3%
5/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
18.8%
3/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
21.4%
3/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
33.3%
2/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
50.0%
1/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
20.0%
3/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Migraine
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.7%
1/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
12.5%
2/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
16.7%
1/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
2/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
13.3%
2/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Eructation
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
16.7%
1/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
2/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.7%
1/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
14.3%
2/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
16.7%
1/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
2/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
13.3%
2/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
18.8%
3/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
16.7%
1/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
16.7%
1/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.7%
1/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Guttate psoriasis
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
16.7%
1/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.7%
1/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Fatigue
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
20.0%
3/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
13.3%
2/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
50.0%
1/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Chills
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.7%
1/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Feeling hot
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Malaise
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.7%
1/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
50.0%
1/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
50.0%
1/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Growing pains
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
50.0%
1/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.7%
1/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
50.0%
1/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
12.5%
2/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Blood triglycerides increased
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
16.7%
1/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
33.3%
2/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Hot flush
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.7%
1/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.7%
1/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.7%
1/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
16.7%
1/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.7%
1/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Eye disorders
Visual impairment
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
7.1%
1/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/15 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/14 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/6 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/2 • Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
|
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