Trial Outcomes & Findings for Dose-finding Pharmacokinetic Study in Healthy Males (NCT NCT03055936)
NCT ID: NCT03055936
Last Updated: 2021-05-27
Results Overview
Levodopa Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
During 24 hours
Results posted on
2021-05-27
Participant Flow
Participant milestones
| Measure |
Group 1
A1 levodopa 50 mg, carbidopa 12.5 mg; B1 levodopa 50 mg, carbidopa 65 mg; C1 levodopa 50 mg, carbidopa 65 mg, ODM-104 50 mg; D1 levodopa 50 mg, carbidopa 65 mg, ODM-104 100 mg
|
Group 2
A2 levodopa 100 mg, carbidopa 25 mg; B2 levodopa 100 mg, carbidopa 65 mg; C2 levodopa 100 mg, carbidopa 65 mg, ODM-104 50 mg; D2 levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
|
Group 3
A3 levodopa 150 mg, carbidopa 37.5 mg; B3 levodopa 150 mg, carbidopa 65 mg; C3 levodopa 150 mg, carbidopa 65 mg, ODM-104 50 mg; D3 levodopa 150 mg, carbidopa 65 mg, ODM-104 100 mg
|
Group 4
A4 (Sinemet: levodopa IR 100 mg, carbidopa 25 mg; B4 levodopa 100 mg, carbidopa 65 mg; C4 levodopa 100 mg, carbidopa 25 mg, ODM-104 100 mg; D4 levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
14
|
14
|
|
Overall Study
COMPLETED
|
12
|
13
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
Group 1
A1 levodopa 50 mg, carbidopa 12.5 mg; B1 levodopa 50 mg, carbidopa 65 mg; C1 levodopa 50 mg, carbidopa 65 mg, ODM-104 50 mg; D1 levodopa 50 mg, carbidopa 65 mg, ODM-104 100 mg
|
Group 2
A2 levodopa 100 mg, carbidopa 25 mg; B2 levodopa 100 mg, carbidopa 65 mg; C2 levodopa 100 mg, carbidopa 65 mg, ODM-104 50 mg; D2 levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
|
Group 3
A3 levodopa 150 mg, carbidopa 37.5 mg; B3 levodopa 150 mg, carbidopa 65 mg; C3 levodopa 150 mg, carbidopa 65 mg, ODM-104 50 mg; D3 levodopa 150 mg, carbidopa 65 mg, ODM-104 100 mg
|
Group 4
A4 (Sinemet: levodopa IR 100 mg, carbidopa 25 mg; B4 levodopa 100 mg, carbidopa 65 mg; C4 levodopa 100 mg, carbidopa 25 mg, ODM-104 100 mg; D4 levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
1
|
|
Overall Study
Personal reason
|
2
|
0
|
1
|
0
|
Baseline Characteristics
Dose-finding Pharmacokinetic Study in Healthy Males
Baseline characteristics by cohort
| Measure |
Group 1
n=14 Participants
A1 levodopa 50 mg, carbidopa 12.5 mg; B1 levodopa 50 mg, carbidopa 65 mg; C1 levodopa 50 mg, carbidopa 65 mg, ODM-104 50 mg; D1 levodopa 50 mg, carbidopa 65 mg, ODM-104 100 mg
|
Group 2
n=14 Participants
A2 levodopa 100 mg, carbidopa 25 mg; B2 levodopa 100 mg, carbidopa 65 mg; C2 levodopa 100 mg, carbidopa 65 mg, ODM-104 50 mg; D2 levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
|
Group 3
n=14 Participants
A3 levodopa 150 mg, carbidopa 37.5 mg; B3 levodopa 150 mg, carbidopa 65 mg; C3 levodopa 150 mg, carbidopa 65 mg, ODM-104 50 mg; D3 levodopa 150 mg, carbidopa 65 mg, ODM-104 100 mg
|
Group 4
n=14 Participants
A4 (Sinemet): levodopa IR 100 mg, carbidopa 25 mg; B4 levodopa 100 mg, carbidopa 65 mg; C4 levodopa 100 mg, carbidopa 25 mg, ODM-104 100 mg; D4 levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
56 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 13.7 • n=99 Participants
|
49.5 years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
48.0 years
STANDARD_DEVIATION 13.5 • n=206 Participants
|
46.0 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
46.4 years
STANDARD_DEVIATION 12.2 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
56 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
52 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=99 Participants
|
14 participants
n=107 Participants
|
14 participants
n=206 Participants
|
14 participants
n=7 Participants
|
14 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: During 24 hoursPopulation: PP (Per Protocol population)
Levodopa Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24)
Outcome measures
| Measure |
A1 50 mg LD + 12.5 mg CD
n=12 Participants
50 mg of MR levodopa + 12.5 mg of carbidopa
|
B1 50 mg LD + 65 mg CD
n=12 Participants
50 mg of MR levodopa + 65 mg of carbidopa
|
C1 50 mg LD + 65 mg CD + 50 mg ODM-104
n=12 Participants
50 mg of MR levodopa + 65 mg carbidopa + 50 mg ODM-104
|
D1 50 mg LD + 65 mg CD + 100 mg ODM-104
n=12 Participants
50 mg of MR levodopa + 65 mg of carbidopa + 100 mg of ODM-104
|
A2 100 mg LD + 25 mg CD
n=13 Participants
100 mg of MR levodopa + 25 mg of carbidopa
|
B2 100 mg LD + 65 mg CD
n=13 Participants
100 mg of MR levodopa + 65 mg of carbidopa
|
C2 100 mg of LD + 65 mg CD + 50 mg ODM-104
n=13 Participants
100 mg of MR levodopa + 65 mg of carbidopa + 50 mg of ODM-104
|
D2 100 mg LD + 65 mg CD + 100 mg of ODM-104
n=13 Participants
100 mg of MR levodopa + 65 mg of carbidopa + 100 mg of ODM-104
|
A3 150 mg LD + 37.5 mg CD
n=12 Participants
150 mg of MR levodopa + 37.5 mg of carbidopa
|
B3 150 mg LD + 65 mg CD
n=12 Participants
150 mg of MR levodopa + 65 mg of carbidopa
|
C3 150 mg LD + 65 mg CD + 50 mg ODM-104
n=12 Participants
150 mg of MR levodopa + 65 mg of carbidopa + 50 mg of ODM-104
|
D3 150 mg LD + 65 mg CD + 100 mg ODM-104
n=12 Participants
150 mg of MR levodopa + 65 mg of carbidopa + 100 mg of ODM-104
|
A4 (Sinemet) 100 mg IR LD + 25 mg CD
n=13 Participants
(Sinemet) 100 mg of IR levodopa + 25 mg of carbidopa
|
B4 100 mg LD + 65 mg CD
n=13 Participants
100 mg of MR levodopa + 65 mg of carbidopa
|
C4 100 mg LD + 25 mg CD + 100 mg ODM-104
n=13 Participants
100 mg of MR levodopa + 25 mg of carbidopa + 100 mg of ODM-104
|
D4 100 mg LD + 65 mg CD + 100 mg ODM-104
n=13 Participants
100 mg of MR levodopa + 65 mg of carbidopa + 100 mg of ODM-104
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Levodopa Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24) Time 0 to the 24 h PK Sample (AUC0-24)
|
4300 h*ng/ml
Interval 3905.0 to 4734.0
|
5423 h*ng/ml
Interval 4928.0 to 5968.0
|
7439 h*ng/ml
Interval 6760.0 to 8186.0
|
9046 h*ng/ml
Interval 8215.0 to 9960.0
|
9643 h*ng/ml
Interval 9060.0 to 10263.0
|
10709 h*ng/ml
Interval 10062.0 to 11399.0
|
15257 h*ng/ml
Interval 14335.0 to 16239.0
|
17896 h*ng/ml
Interval 16814.0 to 19048.0
|
14285 h*ng/ml
Interval 13550.0 to 15061.0
|
15805 h*ng/ml
Interval 14995.0 to 16658.0
|
22473 h*ng/ml
Interval 21316.0 to 23693.0
|
25672 h*ng/ml
Interval 24390.0 to 27021.0
|
7965 h*ng/ml
Interval 6436.0 to 9859.0
|
8994 h*ng/ml
Interval 7286.0 to 11104.0
|
13866 h*ng/ml
Interval 11232.0 to 17118.0
|
16310 h*ng/ml
Interval 13140.0 to 20246.0
|
SECONDARY outcome
Timeframe: 16 hoursExplore fluctuation of levodopa Cmax/Cmin, tau. Figures given are per performed statistical analysis.
Outcome measures
| Measure |
A1 50 mg LD + 12.5 mg CD
n=13 Participants
50 mg of MR levodopa + 12.5 mg of carbidopa
|
B1 50 mg LD + 65 mg CD
n=14 Participants
50 mg of MR levodopa + 65 mg of carbidopa
|
C1 50 mg LD + 65 mg CD + 50 mg ODM-104
n=14 Participants
50 mg of MR levodopa + 65 mg carbidopa + 50 mg ODM-104
|
D1 50 mg LD + 65 mg CD + 100 mg ODM-104
n=13 Participants
50 mg of MR levodopa + 65 mg of carbidopa + 100 mg of ODM-104
|
A2 100 mg LD + 25 mg CD
n=13 Participants
100 mg of MR levodopa + 25 mg of carbidopa
|
B2 100 mg LD + 65 mg CD
n=13 Participants
100 mg of MR levodopa + 65 mg of carbidopa
|
C2 100 mg of LD + 65 mg CD + 50 mg ODM-104
n=13 Participants
100 mg of MR levodopa + 65 mg of carbidopa + 50 mg of ODM-104
|
D2 100 mg LD + 65 mg CD + 100 mg of ODM-104
n=13 Participants
100 mg of MR levodopa + 65 mg of carbidopa + 100 mg of ODM-104
|
A3 150 mg LD + 37.5 mg CD
n=13 Participants
150 mg of MR levodopa + 37.5 mg of carbidopa
|
B3 150 mg LD + 65 mg CD
n=13 Participants
150 mg of MR levodopa + 65 mg of carbidopa
|
C3 150 mg LD + 65 mg CD + 50 mg ODM-104
n=13 Participants
150 mg of MR levodopa + 65 mg of carbidopa + 50 mg of ODM-104
|
D3 150 mg LD + 65 mg CD + 100 mg ODM-104
n=13 Participants
150 mg of MR levodopa + 65 mg of carbidopa + 100 mg of ODM-104
|
A4 (Sinemet) 100 mg IR LD + 25 mg CD
n=13 Participants
(Sinemet) 100 mg of IR levodopa + 25 mg of carbidopa
|
B4 100 mg LD + 65 mg CD
n=14 Participants
100 mg of MR levodopa + 65 mg of carbidopa
|
C4 100 mg LD + 25 mg CD + 100 mg ODM-104
n=14 Participants
100 mg of MR levodopa + 25 mg of carbidopa + 100 mg of ODM-104
|
D4 100 mg LD + 65 mg CD + 100 mg ODM-104
n=13 Participants
100 mg of MR levodopa + 65 mg of carbidopa + 100 mg of ODM-104
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Fluctuation of Levodopa Cmax/Cmin, Tau
|
12.24 (ng/ml)/(ng/ml)
Standard Deviation 5.73
|
7.49 (ng/ml)/(ng/ml)
Standard Deviation 2.23
|
4.16 (ng/ml)/(ng/ml)
Standard Deviation 0.77
|
3.02 (ng/ml)/(ng/ml)
Standard Deviation 1.00
|
11.00 (ng/ml)/(ng/ml)
Standard Deviation 3.30
|
8.32 (ng/ml)/(ng/ml)
Standard Deviation 2.23
|
4.46 (ng/ml)/(ng/ml)
Standard Deviation 1.09
|
3.35 (ng/ml)/(ng/ml)
Standard Deviation 0.74
|
8.45 (ng/ml)/(ng/ml)
Standard Deviation 3.16
|
7.16 (ng/ml)/(ng/ml)
Standard Deviation 3.87
|
3.67 (ng/ml)/(ng/ml)
Standard Deviation 1.29
|
2.82 (ng/ml)/(ng/ml)
Standard Deviation 0.99
|
19.52 (ng/ml)/(ng/ml)
Standard Deviation 14.13
|
9.18 (ng/ml)/(ng/ml)
Standard Deviation 6.23
|
7.63 (ng/ml)/(ng/ml)
Standard Deviation 12.96
|
3.04 (ng/ml)/(ng/ml)
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: 24 hoursLevodopa peak plasma concentration (Cmax)
Outcome measures
| Measure |
A1 50 mg LD + 12.5 mg CD
n=13 Participants
50 mg of MR levodopa + 12.5 mg of carbidopa
|
B1 50 mg LD + 65 mg CD
n=14 Participants
50 mg of MR levodopa + 65 mg of carbidopa
|
C1 50 mg LD + 65 mg CD + 50 mg ODM-104
n=14 Participants
50 mg of MR levodopa + 65 mg carbidopa + 50 mg ODM-104
|
D1 50 mg LD + 65 mg CD + 100 mg ODM-104
n=13 Participants
50 mg of MR levodopa + 65 mg of carbidopa + 100 mg of ODM-104
|
A2 100 mg LD + 25 mg CD
n=13 Participants
100 mg of MR levodopa + 25 mg of carbidopa
|
B2 100 mg LD + 65 mg CD
n=13 Participants
100 mg of MR levodopa + 65 mg of carbidopa
|
C2 100 mg of LD + 65 mg CD + 50 mg ODM-104
n=13 Participants
100 mg of MR levodopa + 65 mg of carbidopa + 50 mg of ODM-104
|
D2 100 mg LD + 65 mg CD + 100 mg of ODM-104
n=13 Participants
100 mg of MR levodopa + 65 mg of carbidopa + 100 mg of ODM-104
|
A3 150 mg LD + 37.5 mg CD
n=13 Participants
150 mg of MR levodopa + 37.5 mg of carbidopa
|
B3 150 mg LD + 65 mg CD
n=13 Participants
150 mg of MR levodopa + 65 mg of carbidopa
|
C3 150 mg LD + 65 mg CD + 50 mg ODM-104
n=13 Participants
150 mg of MR levodopa + 65 mg of carbidopa + 50 mg of ODM-104
|
D3 150 mg LD + 65 mg CD + 100 mg ODM-104
n=13 Participants
150 mg of MR levodopa + 65 mg of carbidopa + 100 mg of ODM-104
|
A4 (Sinemet) 100 mg IR LD + 25 mg CD
n=13 Participants
(Sinemet) 100 mg of IR levodopa + 25 mg of carbidopa
|
B4 100 mg LD + 65 mg CD
n=14 Participants
100 mg of MR levodopa + 65 mg of carbidopa
|
C4 100 mg LD + 25 mg CD + 100 mg ODM-104
n=14 Participants
100 mg of MR levodopa + 25 mg of carbidopa + 100 mg of ODM-104
|
D4 100 mg LD + 65 mg CD + 100 mg ODM-104
n=13 Participants
100 mg of MR levodopa + 65 mg of carbidopa + 100 mg of ODM-104
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Levodopa Peak Plasma Concentration (Cmax)
|
685.92 ng/ml
Standard Deviation 193.08
|
775.36 ng/ml
Standard Deviation 186.29
|
908.86 ng/ml
Standard Deviation 230.23
|
950.38 ng/ml
Standard Deviation 241.60
|
1519.92 ng/ml
Standard Deviation 294.51
|
1593.85 ng/ml
Standard Deviation 288.95
|
1855.38 ng/ml
Standard Deviation 240.58
|
1955.38 ng/ml
Standard Deviation 278.62
|
2105.45 ng/ml
Standard Deviation 422.05
|
2072.73 ng/ml
Standard Deviation 403.78
|
2545.45 ng/ml
Standard Deviation 424.30
|
2616.67 ng/ml
Standard Deviation 388.76
|
1634.62 ng/ml
Standard Deviation 361.70
|
1367.36 ng/ml
Standard Deviation 352.26
|
1711.43 ng/ml
Standard Deviation 316.10
|
1717.69 ng/ml
Standard Deviation 641.60
|
Adverse Events
A1 (Levodopa 50, Carbidopa 12.5)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
B1 (Levodopa 50, Carbidopa 65)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
C1 (Levodopa 50, Carbidopa 65, ODM-104 50)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
D1 (Levodopa 50, Carbidopa 65, ODM-104 100)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
A2 (levodopa100, Carbidopa 25)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
B2 (Levodopa 100, Carbidopa 65)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
C2 (levodopa100, Carbidopa 65, ODM-104 50)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
D2 (Levodopa 100, Carbidopa 65, ODM-104 100)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
A3 (Levodopa 150, Carbidopa 37.5)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
B3 (Levodopa 150, Carbidopa 65)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
C3 (Levodopa 150, Carbidopa 65, ODM-104 50)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
D3 (Levodopa 150, Carbidopa 65, ODM-104 100)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
A4 (Sinemet, Levodopa 100, Carbidopa 25)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
B4 (Levodopa 100, Carbidopa 65)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
C4 (Levodopa 100, Carbidopa 25, ODM-104 100)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
D4 (Levodopa 100, Carbidopa 65, ODM-104 100)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A1 (Levodopa 50, Carbidopa 12.5)
n=14 participants at risk
levodopa 50 mg, carbidopa 12.5 mg
|
B1 (Levodopa 50, Carbidopa 65)
n=14 participants at risk
levodopa 50 mg, carbidopa 65 mg
|
C1 (Levodopa 50, Carbidopa 65, ODM-104 50)
n=14 participants at risk
levodopa 50 mg, carbidopa 65 mg, ODM-104 50 mg
|
D1 (Levodopa 50, Carbidopa 65, ODM-104 100)
n=14 participants at risk
levodopa 50 mg, carbidopa 65 mg, ODM-104 100 mg
|
A2 (levodopa100, Carbidopa 25)
n=14 participants at risk
levodopa 100 mg, carbidopa 25 mg
|
B2 (Levodopa 100, Carbidopa 65)
n=14 participants at risk
levodopa 100 mg, carbidopa 65 mg
|
C2 (levodopa100, Carbidopa 65, ODM-104 50)
n=14 participants at risk
levodopa 100 mg, carbidopa 65 mg, ODM-104 50 mg
|
D2 (Levodopa 100, Carbidopa 65, ODM-104 100)
n=14 participants at risk
levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
|
A3 (Levodopa 150, Carbidopa 37.5)
n=14 participants at risk
levodopa 150 mg, carbidopa 37.5 mg;
|
B3 (Levodopa 150, Carbidopa 65)
n=14 participants at risk
levodopa 150 mg, carbidopa 65 mg
|
C3 (Levodopa 150, Carbidopa 65, ODM-104 50)
n=14 participants at risk
levodopa 150 mg, carbidopa 65 mg, ODM-104 50 mg
|
D3 (Levodopa 150, Carbidopa 65, ODM-104 100)
n=14 participants at risk
levodopa 150 mg, carbidopa 65 mg, ODM-104 100 mg
|
A4 (Sinemet, Levodopa 100, Carbidopa 25)
n=14 participants at risk
levodopa IR (Sinemet) 100 mg, carbidopa 25 mg
|
B4 (Levodopa 100, Carbidopa 65)
n=14 participants at risk
levodopa 100 mg, carbidopa 65 mg
|
C4 (Levodopa 100, Carbidopa 25, ODM-104 100)
n=14 participants at risk
levodopa 100 mg, carbidopa 25 mg, ODM-104 100 mg
|
D4 (Levodopa 100, Carbidopa 65, ODM-104 100)
n=14 participants at risk
levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Diverticulitis
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Reproductive system and breast disorders
Peritonitis
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
Other adverse events
| Measure |
A1 (Levodopa 50, Carbidopa 12.5)
n=14 participants at risk
levodopa 50 mg, carbidopa 12.5 mg
|
B1 (Levodopa 50, Carbidopa 65)
n=14 participants at risk
levodopa 50 mg, carbidopa 65 mg
|
C1 (Levodopa 50, Carbidopa 65, ODM-104 50)
n=14 participants at risk
levodopa 50 mg, carbidopa 65 mg, ODM-104 50 mg
|
D1 (Levodopa 50, Carbidopa 65, ODM-104 100)
n=14 participants at risk
levodopa 50 mg, carbidopa 65 mg, ODM-104 100 mg
|
A2 (levodopa100, Carbidopa 25)
n=14 participants at risk
levodopa 100 mg, carbidopa 25 mg
|
B2 (Levodopa 100, Carbidopa 65)
n=14 participants at risk
levodopa 100 mg, carbidopa 65 mg
|
C2 (levodopa100, Carbidopa 65, ODM-104 50)
n=14 participants at risk
levodopa 100 mg, carbidopa 65 mg, ODM-104 50 mg
|
D2 (Levodopa 100, Carbidopa 65, ODM-104 100)
n=14 participants at risk
levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
|
A3 (Levodopa 150, Carbidopa 37.5)
n=14 participants at risk
levodopa 150 mg, carbidopa 37.5 mg;
|
B3 (Levodopa 150, Carbidopa 65)
n=14 participants at risk
levodopa 150 mg, carbidopa 65 mg
|
C3 (Levodopa 150, Carbidopa 65, ODM-104 50)
n=14 participants at risk
levodopa 150 mg, carbidopa 65 mg, ODM-104 50 mg
|
D3 (Levodopa 150, Carbidopa 65, ODM-104 100)
n=14 participants at risk
levodopa 150 mg, carbidopa 65 mg, ODM-104 100 mg
|
A4 (Sinemet, Levodopa 100, Carbidopa 25)
n=14 participants at risk
levodopa IR (Sinemet) 100 mg, carbidopa 25 mg
|
B4 (Levodopa 100, Carbidopa 65)
n=14 participants at risk
levodopa 100 mg, carbidopa 65 mg
|
C4 (Levodopa 100, Carbidopa 25, ODM-104 100)
n=14 participants at risk
levodopa 100 mg, carbidopa 25 mg, ODM-104 100 mg
|
D4 (Levodopa 100, Carbidopa 65, ODM-104 100)
n=14 participants at risk
levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Psychiatric disorders
Mood altered
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Number of events 3 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
21.4%
3/14 • Number of events 3 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
21.4%
3/14 • Number of events 5 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
35.7%
5/14 • Number of events 5 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
28.6%
4/14 • Number of events 5 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
28.6%
4/14 • Number of events 8 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
21.4%
3/14 • Number of events 3 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
28.6%
4/14 • Number of events 10 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
21.4%
3/14 • Number of events 9 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 3 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 3 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
General disorders
Medical device site rash
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Injury, poisoning and procedural complications
Accident at home
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 3 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Nervous system disorders
Dizziness
|
21.4%
3/14 • Number of events 3 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
3/14 • Number of events 4 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 3 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
21.4%
3/14 • Number of events 3 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 3 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 3 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 3 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 3 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Infections and infestations
Subcutaneous gland infection
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
General disorders
Catheter site pain
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
General disorders
Catheter site phlebitis
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
21.4%
3/14 • Number of events 3 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Cardiac disorders
Palpitations
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Psychiatric disorders
Poor quality sleep
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
14.3%
2/14 • Number of events 7 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 6 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Gingival bleeding
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
General disorders
Chills
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
35.7%
5/14 • Number of events 6 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 3 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Psychiatric disorders
Listless
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
21.4%
3/14 • Number of events 3 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
14.3%
2/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Metabolism and nutrition disorders
Decrease appetite
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
General disorders
Catheter site dryness
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Investigations
Blood creatine phosphokinase increased
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 2 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Infections and infestations
Gingivitis
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
0.00%
0/14 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
7.1%
1/14 • Number of events 1 • Through study completion, upto 15 weeks.
Adverse events are recorded per arm. Same applies to Number of Participants at Risk across the All-Cause Mortality, Serious Adverse Events and/or Other (Not Including Serious) Adverse Events.
|
Additional Information
Clinical Study Director
Orion Corporation, Orion Pharma
Phone: +358104264184
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place