Trial Outcomes & Findings for A Study to Evaluate the Effects of 3 Months Dosing With GW856553, as Assessed FDG-PET/CT Imaging (NCT NCT00633022)
NCT ID: NCT00633022
Last Updated: 2018-10-17
Results Overview
Qualifying artery was defined as the artery (left or right carotid or ascending aorta) with the highest segmental mean of maximum (max) TBR at Baseline. The TBR of the qualifying segment was to be ≥ 1.6. If more than one artery qualified, the hottest (greatest mean of max TBR) artery was the qualifying artery. Baseline was defined as the value between Days -14 to -1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-treatment values.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
99 participants
Primary outcome timeframe
Baseline (Days -14 to -1) and up to Week 12
Results posted on
2018-10-17
Participant Flow
Participants with established atherosclerosis were planned to be enrolled across 4 sites in the United Kingdom from 02 June 2008 to 03 December 2009. Participants were screened within 45 days prior to the first dose and underwent radiological scan within 14 days prior to the first dose.
Participants were randomized in the study to receive oral dose of Losmapimod 7.5 milligram (mg) twice daily, Losmapimod 7.5 mg once daily or placebo.
Participant milestones
| Measure |
Losmapimod 7.5 mg Twice Daily
Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
Losmapimod 7.5 mg Once Daily
Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
|
Placebo
Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
32
|
|
Overall Study
COMPLETED
|
33
|
32
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
5
|
Reasons for withdrawal
| Measure |
Losmapimod 7.5 mg Twice Daily
Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
Losmapimod 7.5 mg Once Daily
Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
|
Placebo
Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
5
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Effects of 3 Months Dosing With GW856553, as Assessed FDG-PET/CT Imaging
Baseline characteristics by cohort
| Measure |
Losmapimod 7.5 mg Twice Daily
n=34 Participants
Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
Losmapimod 7.5 mg Once Daily
n=33 Participants
Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
|
Placebo
n=32 Participants
Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.3 Years
STANDARD_DEVIATION 5.90 • n=5 Participants
|
65.3 Years
STANDARD_DEVIATION 5.94 • n=7 Participants
|
63.7 Years
STANDARD_DEVIATION 6.37 • n=5 Participants
|
63.8 Years
STANDARD_DEVIATION 6.13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Days -14 to -1) and up to Week 12Population: Pharmacodynamic (PD) Population comprised of all participants who provided PD data. Only those participants with data available at the indicated time points were analyzed.
Qualifying artery was defined as the artery (left or right carotid or ascending aorta) with the highest segmental mean of maximum (max) TBR at Baseline. The TBR of the qualifying segment was to be ≥ 1.6. If more than one artery qualified, the hottest (greatest mean of max TBR) artery was the qualifying artery. Baseline was defined as the value between Days -14 to -1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-treatment values.
Outcome measures
| Measure |
Losmapimod 7.5 mg Twice Daily
n=32 Participants
Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
Losmapimod 7.5 mg Once Daily
n=32 Participants
Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
|
Placebo
n=29 Participants
Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
|---|---|---|---|
|
Change From Baseline of Mean of Maximum Tissue to Background Ratio (TBR) in the Qualifying Artery, Following 12 Weeks of Treatment in the Setting of Chronic Statin Therapy
|
-0.146 Maximum tissue to background ratio
Standard Deviation 0.2483
|
-0.122 Maximum tissue to background ratio
Standard Deviation 0.1839
|
-0.070 Maximum tissue to background ratio
Standard Deviation 0.1632
|
SECONDARY outcome
Timeframe: Baseline (Days -14 to -1) and up to Week 12Population: PD Population. Only those participants with data available at the indicated time points were analyzed.
Most diseased segment (MDS) mean of max TBR was mean of all the slice max TBR that compose the most diseased segment. TBR was derived by dividing the arterial vessel wall SUV (tissue) by the background venous blood pool SUV. Unless noted otherwise, the tissue max SUV value for each ROI was used as inputs to the TBR. Baseline was defined as the value between Days -14 to -1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-treatment values.
Outcome measures
| Measure |
Losmapimod 7.5 mg Twice Daily
n=31 Participants
Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
Losmapimod 7.5 mg Once Daily
n=32 Participants
Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
|
Placebo
n=28 Participants
Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
|---|---|---|---|
|
Change From Baseline of the 'Most Diseased Segment (MSD)' Average Maximum TBR in the Qualifying Artery Following 12 Weeks of Treatment With GW856553 or Placebo in the Setting of Chronic Statin Therapy
|
-0.294 Ratio
Standard Deviation 0.3169
|
-0.250 Ratio
Standard Deviation 0.2892
|
-0.221 Ratio
Standard Deviation 0.2132
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Days 7, 14, 21, 28, 42, 56, 70, 84Population: PD Population. Only those participants with data available at the specified time points were analyzed.
CRP is a protein that the liver makes when there is inflammation in the body. It's also called a marker of inflammation, and can be measured with an hs-CRP test. Blood samples were collected to analyze hs-CRP. Baseline was defined as the value on Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-treatment values.
Outcome measures
| Measure |
Losmapimod 7.5 mg Twice Daily
n=34 Participants
Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
Losmapimod 7.5 mg Once Daily
n=33 Participants
Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
|
Placebo
n=32 Participants
Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP)
Day 7
|
-2.293 milligram per litre (mg/L)
Standard Deviation 6.0389
|
-0.446 milligram per litre (mg/L)
Standard Deviation 0.5547
|
0.079 milligram per litre (mg/L)
Standard Deviation 0.6886
|
|
Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP)
Day 14
|
-0.756 milligram per litre (mg/L)
Standard Deviation 4.8068
|
-0.617 milligram per litre (mg/L)
Standard Deviation 2.0800
|
-0.352 milligram per litre (mg/L)
Standard Deviation 1.9871
|
|
Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP)
Day 21
|
-2.250 milligram per litre (mg/L)
Standard Deviation 5.9883
|
0.130 milligram per litre (mg/L)
Standard Deviation 1.1586
|
0.242 milligram per litre (mg/L)
Standard Deviation 1.3125
|
|
Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP)
Day 28
|
-1.394 milligram per litre (mg/L)
Standard Deviation 3.9276
|
1.953 milligram per litre (mg/L)
Standard Deviation 13.6807
|
0.197 milligram per litre (mg/L)
Standard Deviation 3.7474
|
|
Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP)
Day 42
|
-0.085 milligram per litre (mg/L)
Standard Deviation 10.3631
|
-0.145 milligram per litre (mg/L)
Standard Deviation 0.6186
|
-0.009 milligram per litre (mg/L)
Standard Deviation 0.8105
|
|
Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP)
Day 56
|
0.012 milligram per litre (mg/L)
Standard Deviation 6.0287
|
0.077 milligram per litre (mg/L)
Standard Deviation 4.6724
|
0.563 milligram per litre (mg/L)
Standard Deviation 5.0270
|
|
Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP)
Day 70
|
1.313 milligram per litre (mg/L)
Standard Deviation 2.8216
|
0.086 milligram per litre (mg/L)
Standard Deviation 0.9118
|
-0.657 milligram per litre (mg/L)
Standard Deviation 1.3011
|
|
Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP)
Day 84
|
-0.100 milligram per litre (mg/L)
Standard Deviation 1.5281
|
1.452 milligram per litre (mg/L)
Standard Deviation 5.3392
|
-0.313 milligram per litre (mg/L)
Standard Deviation 1.9369
|
SECONDARY outcome
Timeframe: Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98Population: Safety Population comprised of all participants who received at least one dose of study drug. Only those participants with data available at the specified time points were analyzed.
Blood pressure measurements were taken to observe vital signs and included SBP and DBP. SBP and DBP measurements were obtained at Day 1, 7, 14, 21, 28, 42, 56, 70, 84 and follow-up (1-2 weeks post last dose on Day 84).
Outcome measures
| Measure |
Losmapimod 7.5 mg Twice Daily
n=34 Participants
Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
Losmapimod 7.5 mg Once Daily
n=33 Participants
Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
|
Placebo
n=32 Participants
Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
|---|---|---|---|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP: Day 28
|
77.4 millimeter of mercury (mm/Hg)
Standard Deviation 9.64
|
76.5 millimeter of mercury (mm/Hg)
Standard Deviation 9.63
|
76.4 millimeter of mercury (mm/Hg)
Standard Deviation 8.96
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP: Day 42
|
80.6 millimeter of mercury (mm/Hg)
Standard Deviation 11.12
|
72.8 millimeter of mercury (mm/Hg)
Standard Deviation 8.96
|
74.6 millimeter of mercury (mm/Hg)
Standard Deviation 7.94
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP: Day 56
|
77.5 millimeter of mercury (mm/Hg)
Standard Deviation 10.95
|
75.7 millimeter of mercury (mm/Hg)
Standard Deviation 9.09
|
75.9 millimeter of mercury (mm/Hg)
Standard Deviation 7.50
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP: Day 1
|
78.9 millimeter of mercury (mm/Hg)
Standard Deviation 8.67
|
76.7 millimeter of mercury (mm/Hg)
Standard Deviation 11.08
|
75.8 millimeter of mercury (mm/Hg)
Standard Deviation 7.64
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP: Day 7
|
79.4 millimeter of mercury (mm/Hg)
Standard Deviation 8.00
|
73.6 millimeter of mercury (mm/Hg)
Standard Deviation 11.04
|
73.9 millimeter of mercury (mm/Hg)
Standard Deviation 6.81
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP: Day 14
|
76.6 millimeter of mercury (mm/Hg)
Standard Deviation 9.01
|
76.1 millimeter of mercury (mm/Hg)
Standard Deviation 10.55
|
76.4 millimeter of mercury (mm/Hg)
Standard Deviation 9.03
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP: Day 21
|
77.9 millimeter of mercury (mm/Hg)
Standard Deviation 8.44
|
73.8 millimeter of mercury (mm/Hg)
Standard Deviation 12.05
|
74.5 millimeter of mercury (mm/Hg)
Standard Deviation 7.60
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP: Day 70
|
76.3 millimeter of mercury (mm/Hg)
Standard Deviation 4.54
|
73.8 millimeter of mercury (mm/Hg)
Standard Deviation 10.71
|
75.0 millimeter of mercury (mm/Hg)
Standard Deviation 6.30
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP: Day 84
|
75.6 millimeter of mercury (mm/Hg)
Standard Deviation 8.68
|
75.4 millimeter of mercury (mm/Hg)
Standard Deviation 9.51
|
76.2 millimeter of mercury (mm/Hg)
Standard Deviation 8.90
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP: Day 98
|
78.0 millimeter of mercury (mm/Hg)
Standard Deviation 9.81
|
76.6 millimeter of mercury (mm/Hg)
Standard Deviation 10.58
|
73.6 millimeter of mercury (mm/Hg)
Standard Deviation 8.26
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP: Day 1
|
134.9 millimeter of mercury (mm/Hg)
Standard Deviation 16.67
|
132.6 millimeter of mercury (mm/Hg)
Standard Deviation 16.00
|
129.5 millimeter of mercury (mm/Hg)
Standard Deviation 19.22
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP: Day 7
|
132.4 millimeter of mercury (mm/Hg)
Standard Deviation 19.40
|
123.1 millimeter of mercury (mm/Hg)
Standard Deviation 13.58
|
122.4 millimeter of mercury (mm/Hg)
Standard Deviation 13.99
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP: Day 14
|
128.2 millimeter of mercury (mm/Hg)
Standard Deviation 17.08
|
133.3 millimeter of mercury (mm/Hg)
Standard Deviation 19.05
|
130.3 millimeter of mercury (mm/Hg)
Standard Deviation 17.87
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP: Day 21
|
136.9 millimeter of mercury (mm/Hg)
Standard Deviation 15.12
|
132.8 millimeter of mercury (mm/Hg)
Standard Deviation 20.80
|
126.6 millimeter of mercury (mm/Hg)
Standard Deviation 15.76
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP: Day 28
|
131.7 millimeter of mercury (mm/Hg)
Standard Deviation 21.94
|
132.3 millimeter of mercury (mm/Hg)
Standard Deviation 17.79
|
128.5 millimeter of mercury (mm/Hg)
Standard Deviation 18.76
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP: Day 42
|
140.7 millimeter of mercury (mm/Hg)
Standard Deviation 19.78
|
126.5 millimeter of mercury (mm/Hg)
Standard Deviation 17.94
|
128.3 millimeter of mercury (mm/Hg)
Standard Deviation 20.10
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP: Day 56
|
130.1 millimeter of mercury (mm/Hg)
Standard Deviation 17.88
|
130.5 millimeter of mercury (mm/Hg)
Standard Deviation 16.91
|
127.4 millimeter of mercury (mm/Hg)
Standard Deviation 16.69
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP: Day 70
|
136.3 millimeter of mercury (mm/Hg)
Standard Deviation 11.46
|
122.8 millimeter of mercury (mm/Hg)
Standard Deviation 14.56
|
135.4 millimeter of mercury (mm/Hg)
Standard Deviation 19.48
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP: Day 84
|
129.5 millimeter of mercury (mm/Hg)
Standard Deviation 17.78
|
128.1 millimeter of mercury (mm/Hg)
Standard Deviation 14.32
|
126.4 millimeter of mercury (mm/Hg)
Standard Deviation 19.84
|
|
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP: Day 98
|
131.2 millimeter of mercury (mm/Hg)
Standard Deviation 18.06
|
130.9 millimeter of mercury (mm/Hg)
Standard Deviation 17.61
|
125.1 millimeter of mercury (mm/Hg)
Standard Deviation 15.87
|
SECONDARY outcome
Timeframe: Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Vital sign monitoring included heart rate measurement. Heart rate measurements were obtained at Day 1, 7, 14, 21, 28, 42, 56, 70, 84 and follow-up (1-2 weeks post last dose on Day 84).
Outcome measures
| Measure |
Losmapimod 7.5 mg Twice Daily
n=34 Participants
Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
Losmapimod 7.5 mg Once Daily
n=33 Participants
Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
|
Placebo
n=32 Participants
Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
|---|---|---|---|
|
Mean Heart Rate at Indicated Time Points
Heart rate: Day 14
|
57.7 beats per minute (bpm)
Standard Deviation 11.80
|
56.7 beats per minute (bpm)
Standard Deviation 7.66
|
55.4 beats per minute (bpm)
Standard Deviation 10.32
|
|
Mean Heart Rate at Indicated Time Points
Heart rate: Day 21
|
63.9 beats per minute (bpm)
Standard Deviation 12.44
|
54.3 beats per minute (bpm)
Standard Deviation 6.59
|
54.8 beats per minute (bpm)
Standard Deviation 8.97
|
|
Mean Heart Rate at Indicated Time Points
Heart rate: Day 28
|
58.7 beats per minute (bpm)
Standard Deviation 12.25
|
56.4 beats per minute (bpm)
Standard Deviation 9.17
|
57.2 beats per minute (bpm)
Standard Deviation 10.91
|
|
Mean Heart Rate at Indicated Time Points
Heart rate: Day 42
|
60.1 beats per minute (bpm)
Standard Deviation 9.31
|
52.1 beats per minute (bpm)
Standard Deviation 6.46
|
56.8 beats per minute (bpm)
Standard Deviation 10.80
|
|
Mean Heart Rate at Indicated Time Points
Heart rate: Day 1
|
57.6 beats per minute (bpm)
Standard Deviation 11.39
|
56.3 beats per minute (bpm)
Standard Deviation 9.84
|
56.5 beats per minute (bpm)
Standard Deviation 9.79
|
|
Mean Heart Rate at Indicated Time Points
Heart rate: Day 7
|
60.8 beats per minute (bpm)
Standard Deviation 13.97
|
52.5 beats per minute (bpm)
Standard Deviation 6.81
|
54.6 beats per minute (bpm)
Standard Deviation 6.11
|
|
Mean Heart Rate at Indicated Time Points
Heart rate: Day 56
|
58.6 beats per minute (bpm)
Standard Deviation 11.48
|
56.1 beats per minute (bpm)
Standard Deviation 10.12
|
56.5 beats per minute (bpm)
Standard Deviation 10.73
|
|
Mean Heart Rate at Indicated Time Points
Heart rate: Day 70
|
57.3 beats per minute (bpm)
Standard Deviation 7.67
|
53.8 beats per minute (bpm)
Standard Deviation 5.26
|
54.3 beats per minute (bpm)
Standard Deviation 9.52
|
|
Mean Heart Rate at Indicated Time Points
Heart rate: Day 84
|
58.7 beats per minute (bpm)
Standard Deviation 12.07
|
59.2 beats per minute (bpm)
Standard Deviation 10.35
|
55.8 beats per minute (bpm)
Standard Deviation 11.53
|
|
Mean Heart Rate at Indicated Time Points
Heart rate: Day 98
|
61.5 beats per minute (bpm)
Standard Deviation 12.09
|
58.2 beats per minute (bpm)
Standard Deviation 9.00
|
56.1 beats per minute (bpm)
Standard Deviation 9.76
|
SECONDARY outcome
Timeframe: Days 1, 7, 14, 21, 28, 42, 56, 70, 84, 98Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
All 12-lead ECGs were obtained after the participant had rested in the supine position for at least 15 minutes. All ECGs were evaluated by the principal investigator or designee for any other abnormality of potential clinical importance (PCI). Data for abnormal ECG findings have been reported under abnormal - Not clinically significant (NCS) and Abnormal - Clinically significant (CS) categories. Data only for categories with values have been presented.
Outcome measures
| Measure |
Losmapimod 7.5 mg Twice Daily
n=34 Participants
Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
Losmapimod 7.5 mg Once Daily
n=33 Participants
Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
|
Placebo
n=32 Participants
Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
|---|---|---|---|
|
Number of Participants With 12-lead Electrocardiogram (ECG) Findings
Day 1 pre-dose 1: Abnormal-NCS
|
19 Participants
|
17 Participants
|
15 Participants
|
|
Number of Participants With 12-lead Electrocardiogram (ECG) Findings
Day 1 pre-dose 2:Abnormal-NCS
|
19 Participants
|
16 Participants
|
15 Participants
|
|
Number of Participants With 12-lead Electrocardiogram (ECG) Findings
Day 1 pre-dose 3: Abnormal-NCS
|
18 Participants
|
16 Participants
|
15 Participants
|
|
Number of Participants With 12-lead Electrocardiogram (ECG) Findings
Day 7 pre-dose 1: Abnormal-NCS
|
8 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With 12-lead Electrocardiogram (ECG) Findings
Day 14 pre-dose 1: Abnormal-NCS
|
16 Participants
|
17 Participants
|
16 Participants
|
|
Number of Participants With 12-lead Electrocardiogram (ECG) Findings
Day 28 pre-dose 1: Abnormal-NCS
|
16 Participants
|
14 Participants
|
13 Participants
|
|
Number of Participants With 12-lead Electrocardiogram (ECG) Findings
Day 28 pre-dose 1: Abnormal-CS
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With 12-lead Electrocardiogram (ECG) Findings
Day 56 pre-dose 1: Abnormal-NCS
|
17 Participants
|
15 Participants
|
12 Participants
|
|
Number of Participants With 12-lead Electrocardiogram (ECG) Findings
Day 70 pre-dose 1: Abnormal-NCS
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With 12-lead Electrocardiogram (ECG) Findings
Day 84 pre-dose 1: Abnormal-NCS
|
15 Participants
|
17 Participants
|
11 Participants
|
|
Number of Participants With 12-lead Electrocardiogram (ECG) Findings
Day 98: Abnormal-NCS
|
15 Participants
|
18 Participants
|
13 Participants
|
|
Number of Participants With 12-lead Electrocardiogram (ECG) Findings
Day 98: Abnormal-CS
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Follow-up (Day 98)Population: Safety Population.
Clinical chemistry range for PCI was calcium low \<1.5 mill mole per litre (mmol/L), high \> 3.24 mmol/L; creatinine high 155 mmol/L; glucose low \< 2.2 (age: 13-99) mmol/L, high \> 27.8 (age: 13-99) mmol/L; phosphorus low \< 2.8 mmol/L, high \> 6.5 mmol/L; sodium low \< 125 mmol/L, high \> 150 mmol/L. Categories with values have been presented.
Outcome measures
| Measure |
Losmapimod 7.5 mg Twice Daily
n=34 Participants
Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
Losmapimod 7.5 mg Once Daily
n=33 Participants
Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
|
Placebo
n=32 Participants
Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Clinical Chemistry Abnormalities of PCI
Calcium low
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Abnormalities of PCI
Calcium high
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Abnormalities of PCI
Glucose low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Abnormalities of PCI
Glucose high
|
7 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Clinical Chemistry Abnormalities of PCI
Potassium low
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Abnormalities of PCI
Sodium low
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Clinical Chemistry Abnormalities of PCI
Creatinine high
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Clinical Chemistry Abnormalities of PCI
Chloride low
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Follow-up (Day 98)Population: Safety Population.
Hematology range for PCI was: white blood cell count (WBC) low \< 1.1 x109/ L; hemoglobin low \<71 (age: 18-99) grams per litre (g/L), high \>199 (age: 18-99) g/L; hematocrit low 0.201 (age: 18-99) ratio of 1 high 0.599 (age: 18-99) ratio of 1 and platelet count low \< 80 x109/ L, high \> 500 x109/ L. Categories with values have been presented.
Outcome measures
| Measure |
Losmapimod 7.5 mg Twice Daily
n=34 Participants
Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
Losmapimod 7.5 mg Once Daily
n=33 Participants
Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
|
Placebo
n=32 Participants
Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Hematology Abnormalities of PCI
Eosinophils high
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Hematology Abnormalities of PCI
Eosinophils low
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Abnormalities of PCI
Haemoglobin low
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Abnormalities of PCI
Lymphocytes low
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Hematology Abnormalities of PCI
Lymphocytes high
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Hematology Abnormalities of PCI
MCH high
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Abnormalities of PCI
Monocytes high
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Abnormalities of PCI
Neutrophils low
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Abnormalities of PCI
Neutrophils high
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology Abnormalities of PCI
RBC count low
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Abnormalities of PCI
Reticulocytes low
|
4 Participants
|
4 Participants
|
9 Participants
|
|
Number of Participants With Hematology Abnormalities of PCI
Reticulocytes high
|
18 Participants
|
10 Participants
|
13 Participants
|
|
Number of Participants With Hematology Abnormalities of PCI
Platelet count low
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology Abnormalities of PCI
WBC count low
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98Population: Safety Population.
A urine dipstick test is a basic diagnostic tool used to determine pathological changes in a participant's urine in standard urinalysis. Data was analyzed for urine occult blood, urine glucose, urine ketones and urine protein ranging from 2+, trace, 1+, 3+, 1+or 1/4, 3+ or 1 and trace or 1/10, indicating proportional concentrations in the urine sample. Data has been presented for categories with values for positive findings.
Outcome measures
| Measure |
Losmapimod 7.5 mg Twice Daily
n=34 Participants
Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
Losmapimod 7.5 mg Once Daily
n=33 Participants
Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
|
Placebo
n=32 Participants
Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Urinalysis Dipstick Results
Day 42: Urine Protein, trace
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 42: Urine Protein, 1+
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 98: Urine Protein, 1+
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 1: Urine Occult Blood, trace
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 1: Urine Occult Blood, 3+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 1: Urine Glucose, 1+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 1: Urine Protein, trace
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 1: Urine Protein, 1+
|
2 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 7: Urine Occult Blood, 1+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 7: Urine Occult Blood, 3+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 7: Urine Protein, trace
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 7: Urine Protein, 1+
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 14: Urine Occult Blood, 2+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 14: Urine Occult Blood, trace
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 14: Urine Occult Blood, 1+
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 14: Urine Ketones, trace
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 14: Urine Protein, trace
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 14: Urine Protein, 1+
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 21: Urine Occult Blood, trace
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 21: Urine Ketones, trace
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 21: Urine Protein, trace
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 21: Urine Protein, 1+
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 28: Urine Occult Blood, 2+
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 28: Urine Occult Blood, trace
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 28: Urine Protein, trace
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 28: Urine Protein, 1+
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 42: Urine Occult Blood, 2+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 56: Urine Occult Blood, 2+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 56: Urine Occult Blood, trace
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 56: Urine Occult Blood, 1+
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 56: Urine Glucose, Trace or 1/10
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 56: Urine Ketones, trace
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 56: Urine Protein, trace
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 56: Urine Protein, 1+
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 70: Urine Occult Blood, 2+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 70: Urine Occult Blood, trace
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 70: Urine Protein, 2+
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 70: Urine Protein, trace
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 70: Urine Protein, 1+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 84: Urine Occult Blood, 2+
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 84: Urine Occult Blood, trace
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 84: Urine Occult Blood, 1+
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 84: Urine Ketones, trace
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 84: Urine Protein, 2+
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 84: Urine Protein, trace
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 84: Urine Protein, 1+
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 98: Urine Occult Blood, 2+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 98: Urine Occult Blood, trace
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 98: Urine Occult Blood, 1+
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 98: Urine Occult Blood, 3+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 98: Urine Glucose, 3+ OR 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
Day 98: Urine Protein, trace
|
2 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Follow-up (Day 98)Population: Safety Population.
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Outcome measures
| Measure |
Losmapimod 7.5 mg Twice Daily
n=34 Participants
Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
Losmapimod 7.5 mg Once Daily
n=33 Participants
Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
|
Placebo
n=32 Participants
Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
|
29 Participants
|
28 Participants
|
31 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
|
4 Participants
|
1 Participants
|
3 Participants
|
Adverse Events
Losmapimod 7.5 mg Twice Daily
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Losmapimod 7.5 mg Once Daily
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 28 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Losmapimod 7.5 mg Twice Daily
n=34 participants at risk
Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
Losmapimod 7.5 mg Once Daily
n=33 participants at risk
Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
|
Placebo
n=32 participants at risk
Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
|---|---|---|---|
|
Infections and infestations
Meningitis herpes
|
2.9%
1/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
2.9%
1/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
General disorders
Pain
|
2.9%
1/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
General disorders
Chest pain
|
2.9%
1/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Nervous system disorders
Presyncope
|
2.9%
1/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.1%
1/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.0%
1/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.0%
1/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.0%
1/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Injury, poisoning and procedural complications
Road trafic accident
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.1%
1/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.1%
1/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
Other adverse events
| Measure |
Losmapimod 7.5 mg Twice Daily
n=34 participants at risk
Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
Losmapimod 7.5 mg Once Daily
n=33 participants at risk
Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
|
Placebo
n=32 participants at risk
Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
20.6%
7/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
30.3%
10/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
31.2%
10/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Nervous system disorders
Dizziness
|
5.9%
2/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.1%
2/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
12.5%
4/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
12.5%
4/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Nervous system disorders
Migraine
|
2.9%
1/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.1%
2/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.5%
8/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
9.1%
3/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
9.4%
3/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Gastrointestinal disorders
Nausea
|
8.8%
3/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.1%
2/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.2%
2/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Gastrointestinal disorders
Constipation
|
8.8%
3/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
9.4%
3/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.8%
3/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.1%
1/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Gastrointestinal disorders
Toothache
|
11.8%
4/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
2/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.0%
1/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.1%
1/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.0%
1/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.2%
2/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.1%
2/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.2%
2/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.1%
2/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.8%
3/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.0%
1/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
9.4%
3/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.9%
1/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
9.1%
3/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
9.4%
3/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.8%
4/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.1%
2/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.1%
1/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
15.6%
5/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.1%
2/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.1%
1/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.2%
2/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.9%
2/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
General disorders
Fatigue
|
11.8%
4/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.1%
2/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
15.6%
5/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
General disorders
Chest pain
|
8.8%
3/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.1%
2/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.2%
2/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
General disorders
Chest discomfort
|
5.9%
2/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.0%
1/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.1%
1/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
General disorders
Pyrexia
|
5.9%
2/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
3/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
9.1%
3/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.1%
1/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
2/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
9.1%
3/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.1%
1/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
9.1%
3/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
2/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.1%
2/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Infections and infestations
Nasopharyngitis
|
14.7%
5/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
12.1%
4/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.2%
2/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.0%
1/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.2%
2/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Cardiac disorders
Palpitations
|
5.9%
2/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
9.1%
3/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.1%
1/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Cardiac disorders
Angina pectoris
|
5.9%
2/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.0%
1/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
2.9%
1/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.1%
2/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.1%
2/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.1%
1/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.2%
2/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Investigations
C-reactive protein increased
|
2.9%
1/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
9.1%
3/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Investigations
Blood urine present
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.1%
2/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
2.9%
1/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.0%
1/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
9.4%
3/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Eye disorders
Eye pain
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
9.1%
3/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.1%
2/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
3.1%
1/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.1%
2/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Psychiatric disorders
Depressed mood
|
5.9%
2/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.1%
2/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
6.2%
2/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
|
Surgical and medical procedures
Tooth extraction
|
5.9%
2/34 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/33 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/32 • SAEs and non-serious AEs were collected up to Follow-up visit (Day 98)
SAEs and non-serious AEs are reported for Safety Population.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER