Trial Outcomes & Findings for A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (Core OLE) (NCT NCT04712669)
NCT ID: NCT04712669
Last Updated: 2025-06-04
Results Overview
Pulmonary vascular resistance (PVR) was measured by right heart catheterization (RHC)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
24 Weeks
Results posted on
2025-06-04
Participant Flow
Out of 108 subjects who are dosed in Double Blind phase 76 Subjects have enrolled in Open Label extension phase.
Participant milestones
| Measure |
Rodatristat Ethyl 300 mg BID
MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks
|
Rodatristat Ethyl 600 mg BID
MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks
|
Placebo
MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks
|
Placebo-Rodatristat Ethyl 300 mg
Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase
|
Placebo-Rodatristat Ethyl 600 mg
Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase
|
Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 300 mg
Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase
|
Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 600 mg
Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase
|
Rodatristat Ethyl 600 Mg-Rodatristat Ethyl 600 mg
Subjects whose actual treatment group is Rodatristat ethyl two 600 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase
|
|---|---|---|---|---|---|---|---|---|
|
Double Blind Phase
STARTED
|
36
|
36
|
36
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind Phase
COMPLETED
|
28
|
26
|
32
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind Phase
NOT COMPLETED
|
8
|
10
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Open Label Phase
STARTED
|
0
|
0
|
0
|
15
|
16
|
22
|
2
|
21
|
|
Open Label Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open Label Phase
NOT COMPLETED
|
0
|
0
|
0
|
15
|
16
|
22
|
2
|
21
|
Reasons for withdrawal
| Measure |
Rodatristat Ethyl 300 mg BID
MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks
|
Rodatristat Ethyl 600 mg BID
MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks
|
Placebo
MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks
|
Placebo-Rodatristat Ethyl 300 mg
Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase
|
Placebo-Rodatristat Ethyl 600 mg
Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase
|
Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 300 mg
Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase
|
Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 600 mg
Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase
|
Rodatristat Ethyl 600 Mg-Rodatristat Ethyl 600 mg
Subjects whose actual treatment group is Rodatristat ethyl two 600 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase
|
|---|---|---|---|---|---|---|---|---|
|
Double Blind Phase
Adverse Event
|
4
|
4
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind Phase
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind Phase
Withdrawal by Subject
|
3
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind Phase
Termination by Sponsor
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Open Label Phase
Adverse Event
|
0
|
0
|
0
|
1
|
1
|
3
|
1
|
2
|
|
Open Label Phase
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Open Label Phase
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Open Label Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Open Label Phase
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Open Label Phase
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
5
|
5
|
0
|
4
|
|
Open Label Phase
Termination by Sponsor
|
0
|
0
|
0
|
11
|
9
|
14
|
0
|
14
|
Baseline Characteristics
Safety Population
Baseline characteristics by cohort
| Measure |
Rodatristat Ethyl 300 mg BID
n=36 Participants
MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks
|
Rodatristat Ethyl 600 mg BID
n=36 Participants
MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks
|
Placebo
n=36 Participants
MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks
|
Placebo-Rodatristat Ethyl 300 mg
n=15 Participants
Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase
|
Placebo-Rodatristat Ethyl 600 mg
n=16 Participants
Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase
|
Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 300 mg
n=22 Participants
Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase
|
Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 600 mg
n=2 Participants
Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase
|
Rodatristat Ethyl 600 Mg-Rodatristat Ethyl 600 mg
n=21 Participants
Subjects whose actual treatment group is Rodatristat ethyl two 600 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
Double Blind Phase · <=18 years
|
0 Participants
n=36 Participants • Safety Population
|
0 Participants
n=36 Participants • Safety Population
|
0 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
n=108 Participants • Safety Population
|
|
Age, Categorical
Double Blind Phase · Between 18 and 65 years
|
22 Participants
n=36 Participants • Safety Population
|
29 Participants
n=36 Participants • Safety Population
|
27 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
78 Participants
n=108 Participants • Safety Population
|
|
Age, Categorical
Double Blind Phase · >=65 years
|
14 Participants
n=36 Participants • Safety Population
|
7 Participants
n=36 Participants • Safety Population
|
9 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
30 Participants
n=108 Participants • Safety Population
|
|
Age, Categorical
Open Label Phase · <=18 years
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
n=15 Participants • Safety Population
|
0 Participants
n=16 Participants • Safety Population
|
0 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
0 Participants
n=21 Participants • Safety Population
|
0 Participants
n=76 Participants • Safety Population
|
|
Age, Categorical
Open Label Phase · Between 18 and 65 years
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
10 Participants
n=15 Participants • Safety Population
|
13 Participants
n=16 Participants • Safety Population
|
10 Participants
n=22 Participants • Safety Population
|
2 Participants
n=2 Participants • Safety Population
|
16 Participants
n=21 Participants • Safety Population
|
51 Participants
n=76 Participants • Safety Population
|
|
Age, Categorical
Open Label Phase · >=65 years
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
5 Participants
n=15 Participants • Safety Population
|
3 Participants
n=16 Participants • Safety Population
|
12 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
5 Participants
n=21 Participants • Safety Population
|
25 Participants
n=76 Participants • Safety Population
|
|
Age, Continuous
Double Blind Phase
|
56.4 Years
STANDARD_DEVIATION 14.3 • n=36 Participants • Safety Population
|
48.4 Years
STANDARD_DEVIATION 15.31 • n=36 Participants • Safety Population
|
53.7 Years
STANDARD_DEVIATION 13.76 • n=36 Participants • Safety Population
|
—
|
—
|
—
|
—
|
—
|
52.83 Years
STANDARD_DEVIATION 14.84 • n=108 Participants • Safety Population
|
|
Age, Continuous
Open Label Phase
|
—
|
—
|
—
|
53.8 Years
STANDARD_DEVIATION 13.96 • n=15 Participants • Safety Population
|
53.4 Years
STANDARD_DEVIATION 14.19 • n=16 Participants • Safety Population
|
59.8 Years
STANDARD_DEVIATION 15.84 • n=22 Participants • Safety Population
|
53.0 Years
STANDARD_DEVIATION 5.65 • n=2 Participants • Safety Population
|
51.1 Years
STANDARD_DEVIATION 13.3 • n=21 Participants • Safety Population
|
54.68 Years
STANDARD_DEVIATION 14.65 • n=76 Participants • Safety Population
|
|
Sex: Female, Male
Double Blind Phase · Female
|
28 Participants
n=36 Participants • Safety Population
|
31 Participants
n=36 Participants • Safety Population
|
26 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
85 Participants
n=108 Participants • Safety Population
|
|
Sex: Female, Male
Double Blind Phase · Male
|
8 Participants
n=36 Participants • Safety Population
|
5 Participants
n=36 Participants • Safety Population
|
10 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
23 Participants
n=108 Participants • Safety Population
|
|
Sex: Female, Male
Open Label Phase · Female
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
13 Participants
n=15 Participants • Safety Population
|
12 Participants
n=16 Participants • Safety Population
|
17 Participants
n=22 Participants • Safety Population
|
1 Participants
n=2 Participants • Safety Population
|
19 Participants
n=21 Participants • Safety Population
|
62 Participants
n=76 Participants • Safety Population
|
|
Sex: Female, Male
Open Label Phase · Male
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
2 Participants
n=15 Participants • Safety Population
|
4 Participants
n=16 Participants • Safety Population
|
5 Participants
n=22 Participants • Safety Population
|
1 Participants
n=2 Participants • Safety Population
|
2 Participants
n=21 Participants • Safety Population
|
14 Participants
n=76 Participants • Safety Population
|
|
Ethnicity (NIH/OMB)
Double Blind Phase · Hispanic or Latino
|
4 Participants
n=36 Participants • Safety Population
|
5 Participants
n=36 Participants • Safety Population
|
2 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
11 Participants
n=108 Participants • Safety Population
|
|
Ethnicity (NIH/OMB)
Double Blind Phase · Not Hispanic or Latino
|
32 Participants
n=36 Participants • Safety Population
|
29 Participants
n=36 Participants • Safety Population
|
33 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
94 Participants
n=108 Participants • Safety Population
|
|
Ethnicity (NIH/OMB)
Double Blind Phase · Unknown or Not Reported
|
0 Participants
n=36 Participants • Safety Population
|
2 Participants
n=36 Participants • Safety Population
|
1 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
3 Participants
n=108 Participants • Safety Population
|
|
Ethnicity (NIH/OMB)
Open Label Phase · Hispanic or Latino
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
1 Participants
n=15 Participants • Safety Population
|
1 Participants
n=16 Participants • Safety Population
|
2 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
2 Participants
n=21 Participants • Safety Population
|
6 Participants
n=76 Participants • Safety Population
|
|
Ethnicity (NIH/OMB)
Open Label Phase · Not Hispanic or Latino
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
14 Participants
n=15 Participants • Safety Population
|
14 Participants
n=16 Participants • Safety Population
|
20 Participants
n=22 Participants • Safety Population
|
2 Participants
n=2 Participants • Safety Population
|
18 Participants
n=21 Participants • Safety Population
|
68 Participants
n=76 Participants • Safety Population
|
|
Ethnicity (NIH/OMB)
Open Label Phase · Unknown or Not Reported
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
n=15 Participants • Safety Population
|
1 Participants
n=16 Participants • Safety Population
|
0 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
1 Participants
n=21 Participants • Safety Population
|
2 Participants
n=76 Participants • Safety Population
|
|
Race (NIH/OMB)
Double Blind Phase · American Indian or Alaska Native
|
1 Participants
n=36 Participants • Safety Population
|
0 Participants
n=36 Participants • Safety Population
|
0 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
1 Participants
n=108 Participants • Safety Population
|
|
Race (NIH/OMB)
Double Blind Phase · Asian
|
1 Participants
n=36 Participants • Safety Population
|
1 Participants
n=36 Participants • Safety Population
|
2 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
4 Participants
n=108 Participants • Safety Population
|
|
Race (NIH/OMB)
Double Blind Phase · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=36 Participants • Safety Population
|
0 Participants
n=36 Participants • Safety Population
|
0 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
n=108 Participants • Safety Population
|
|
Race (NIH/OMB)
Double Blind Phase · Black or African American
|
0 Participants
n=36 Participants • Safety Population
|
1 Participants
n=36 Participants • Safety Population
|
2 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
3 Participants
n=108 Participants • Safety Population
|
|
Race (NIH/OMB)
Double Blind Phase · White
|
29 Participants
n=36 Participants • Safety Population
|
29 Participants
n=36 Participants • Safety Population
|
25 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
83 Participants
n=108 Participants • Safety Population
|
|
Race (NIH/OMB)
Double Blind Phase · More than one race
|
0 Participants
n=36 Participants • Safety Population
|
0 Participants
n=36 Participants • Safety Population
|
0 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
n=108 Participants • Safety Population
|
|
Race (NIH/OMB)
Double Blind Phase · Unknown or Not Reported
|
5 Participants
n=36 Participants • Safety Population
|
5 Participants
n=36 Participants • Safety Population
|
7 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
17 Participants
n=108 Participants • Safety Population
|
|
Race (NIH/OMB)
Open Label Phase · American Indian or Alaska Native
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
n=15 Participants • Safety Population
|
0 Participants
n=16 Participants • Safety Population
|
1 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
0 Participants
n=21 Participants • Safety Population
|
1 Participants
n=76 Participants • Safety Population
|
|
Race (NIH/OMB)
Open Label Phase · Asian
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
1 Participants
n=15 Participants • Safety Population
|
1 Participants
n=16 Participants • Safety Population
|
1 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
1 Participants
n=21 Participants • Safety Population
|
4 Participants
n=76 Participants • Safety Population
|
|
Race (NIH/OMB)
Open Label Phase · Native Hawaiian or Other Pacific Islander
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
n=15 Participants • Safety Population
|
0 Participants
n=16 Participants • Safety Population
|
0 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
0 Participants
n=21 Participants • Safety Population
|
0 Participants
n=76 Participants • Safety Population
|
|
Race (NIH/OMB)
Open Label Phase · Black or African American
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
n=15 Participants • Safety Population
|
2 Participants
n=16 Participants • Safety Population
|
0 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
0 Participants
n=21 Participants • Safety Population
|
2 Participants
n=76 Participants • Safety Population
|
|
Race (NIH/OMB)
Open Label Phase · White
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
11 Participants
n=15 Participants • Safety Population
|
10 Participants
n=16 Participants • Safety Population
|
17 Participants
n=22 Participants • Safety Population
|
2 Participants
n=2 Participants • Safety Population
|
17 Participants
n=21 Participants • Safety Population
|
57 Participants
n=76 Participants • Safety Population
|
|
Race (NIH/OMB)
Open Label Phase · More than one race
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
n=15 Participants • Safety Population
|
0 Participants
n=16 Participants • Safety Population
|
0 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
0 Participants
n=21 Participants • Safety Population
|
0 Participants
n=76 Participants • Safety Population
|
|
Race (NIH/OMB)
Open Label Phase · Unknown or Not Reported
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
3 Participants
n=15 Participants • Safety Population
|
3 Participants
n=16 Participants • Safety Population
|
3 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
3 Participants
n=21 Participants • Safety Population
|
12 Participants
n=76 Participants • Safety Population
|
|
Region of Enrollment
United States
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
4 Participants
n=15 Participants • Safety Population
|
8 Participants
n=16 Participants • Safety Population
|
9 Participants
n=22 Participants • Safety Population
|
2 Participants
n=2 Participants • Safety Population
|
11 Participants
n=21 Participants • Safety Population
|
34 Participants
n=76 Participants • Safety Population
|
|
Region of Enrollment
Canada
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
n=15 Participants • Safety Population
|
1 Participants
n=16 Participants • Safety Population
|
0 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
0 Participants
n=21 Participants • Safety Population
|
1 Participants
n=76 Participants • Safety Population
|
|
Region of Enrollment
Austria
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
1 Participants
n=15 Participants • Safety Population
|
0 Participants
n=16 Participants • Safety Population
|
0 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
0 Participants
n=21 Participants • Safety Population
|
1 Participants
n=76 Participants • Safety Population
|
|
Region of Enrollment
Belgium
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
n=15 Participants • Safety Population
|
0 Participants
n=16 Participants • Safety Population
|
0 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
1 Participants
n=21 Participants • Safety Population
|
1 Participants
n=76 Participants • Safety Population
|
|
Region of Enrollment
Bulgaria
|
0 Participants
n=36 Participants • Safety Population
|
0 Participants
n=36 Participants • Safety Population
|
1 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
1 Participants
n=108 Participants • Safety Population
|
|
Region of Enrollment
Czechia
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
1 Participants
n=15 Participants • Safety Population
|
0 Participants
n=16 Participants • Safety Population
|
2 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
0 Participants
n=21 Participants • Safety Population
|
3 Participants
n=76 Participants • Safety Population
|
|
Region of Enrollment
France
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
2 Participants
n=15 Participants • Safety Population
|
2 Participants
n=16 Participants • Safety Population
|
3 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
3 Participants
n=21 Participants • Safety Population
|
10 Participants
n=76 Participants • Safety Population
|
|
Region of Enrollment
Germany
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
2 Participants
n=15 Participants • Safety Population
|
0 Participants
n=16 Participants • Safety Population
|
0 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
1 Participants
n=21 Participants • Safety Population
|
3 Participants
n=76 Participants • Safety Population
|
|
Region of Enrollment
Italy
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
n=15 Participants • Safety Population
|
1 Participants
n=16 Participants • Safety Population
|
2 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
0 Participants
n=21 Participants • Safety Population
|
3 Participants
n=76 Participants • Safety Population
|
|
Region of Enrollment
Latvia
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
1 Participants
n=15 Participants • Safety Population
|
1 Participants
n=16 Participants • Safety Population
|
4 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
1 Participants
n=21 Participants • Safety Population
|
7 Participants
n=76 Participants • Safety Population
|
|
Region of Enrollment
Poland
|
1 Participants
n=36 Participants • Safety Population
|
0 Participants
n=36 Participants • Safety Population
|
1 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
2 Participants
n=108 Participants • Safety Population
|
|
Region of Enrollment
Spain
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
2 Participants
n=15 Participants • Safety Population
|
0 Participants
n=16 Participants • Safety Population
|
0 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
0 Participants
n=21 Participants • Safety Population
|
2 Participants
n=76 Participants • Safety Population
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=36 Participants • Safety Population
|
0 Participants
n=36 Participants • Safety Population
|
1 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
3 Participants
n=108 Participants • Safety Population
|
|
Region of Enrollment
Bosnia and Herzegovina
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
n=15 Participants • Safety Population
|
1 Participants
n=16 Participants • Safety Population
|
0 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
0 Participants
n=21 Participants • Safety Population
|
1 Participants
n=76 Participants • Safety Population
|
|
Region of Enrollment
Moldova
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
2 Participants
n=15 Participants • Safety Population
|
2 Participants
n=16 Participants • Safety Population
|
2 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
4 Participants
n=21 Participants • Safety Population
|
10 Participants
n=76 Participants • Safety Population
|
|
Duration since PAH diagnosis
Double Blind Phase
|
6.18 Year
STANDARD_DEVIATION 4.268 • n=36 Participants • Safety Population
|
6.69 Year
STANDARD_DEVIATION 4.913 • n=36 Participants • Safety Population
|
8.65 Year
STANDARD_DEVIATION 6.486 • n=36 Participants • Safety Population
|
—
|
—
|
—
|
—
|
—
|
7.17 Year
STANDARD_DEVIATION 5.4 • n=108 Participants • Safety Population
|
|
Duration since PAH diagnosis
Open Label Phase
|
—
|
—
|
—
|
10.54 Year
STANDARD_DEVIATION 5.97 • n=15 Participants • Safety Population
|
7.39 Year
STANDARD_DEVIATION 6.98 • n=16 Participants • Safety Population
|
5.82 Year
STANDARD_DEVIATION 4.86 • n=22 Participants • Safety Population
|
8.05 Year
STANDARD_DEVIATION 3.18 • n=2 Participants • Safety Population
|
6.14 Year
STANDARD_DEVIATION 4.85 • n=21 Participants • Safety Population
|
7.22 Year
STANDARD_DEVIATION 5.8 • n=76 Participants • Safety Population
|
|
Duration since PAH diagnosis category
Double Blind Phase · <=5 years
|
18 Participants
n=36 Participants • Safety Population
|
17 Participants
n=36 Participants • Safety Population
|
13 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
48 Participants
n=108 Participants • Safety Population
|
|
Duration since PAH diagnosis category
Double Blind Phase · >5 years
|
18 Participants
n=36 Participants • Safety Population
|
19 Participants
n=36 Participants • Safety Population
|
23 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
60 Participants
n=108 Participants • Safety Population
|
|
Duration since PAH diagnosis category
Open Label Phase · <=5 years
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
2 Participants
n=15 Participants • Safety Population
|
8 Participants
n=16 Participants • Safety Population
|
14 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
10 Participants
n=21 Participants • Safety Population
|
34 Participants
n=76 Participants • Safety Population
|
|
Duration since PAH diagnosis category
Open Label Phase · >5 years
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
13 Participants
n=15 Participants • Safety Population
|
8 Participants
n=16 Participants • Safety Population
|
8 Participants
n=22 Participants • Safety Population
|
2 Participants
n=2 Participants • Safety Population
|
11 Participants
n=21 Participants • Safety Population
|
42 Participants
n=76 Participants • Safety Population
|
|
PAH classification
Double Blind Phase · IPAH
|
13 Participants
n=36 Participants • Safety Population
|
19 Participants
n=36 Participants • Safety Population
|
26 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
58 Participants
n=108 Participants • Safety Population
|
|
PAH classification
Double Blind Phase · HPAH
|
5 Participants
n=36 Participants • Safety Population
|
5 Participants
n=36 Participants • Safety Population
|
4 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
14 Participants
n=108 Participants • Safety Population
|
|
PAH classification
Double Blind Phase · Drug or toxin
|
3 Participants
n=36 Participants • Safety Population
|
3 Participants
n=36 Participants • Safety Population
|
2 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
8 Participants
n=108 Participants • Safety Population
|
|
PAH classification
Double Blind Phase · PAH associated with connective tissue disease
|
11 Participants
n=36 Participants • Safety Population
|
3 Participants
n=36 Participants • Safety Population
|
1 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
15 Participants
n=108 Participants • Safety Population
|
|
PAH classification
Double Blind Phase · PAH associated with congenital systemic pulmonary shunt
|
4 Participants
n=36 Participants • Safety Population
|
6 Participants
n=36 Participants • Safety Population
|
3 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
13 Participants
n=108 Participants • Safety Population
|
|
PAH classification
Open Label Phase · IPAH
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
11 Participants
n=15 Participants • Safety Population
|
12 Participants
n=16 Participants • Safety Population
|
10 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
8 Participants
n=21 Participants • Safety Population
|
41 Participants
n=76 Participants • Safety Population
|
|
PAH classification
Open Label Phase · HPAH
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
1 Participants
n=15 Participants • Safety Population
|
2 Participants
n=16 Participants • Safety Population
|
2 Participants
n=22 Participants • Safety Population
|
1 Participants
n=2 Participants • Safety Population
|
3 Participants
n=21 Participants • Safety Population
|
9 Participants
n=76 Participants • Safety Population
|
|
PAH classification
Open Label Phase · Drug or toxin
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
1 Participants
n=15 Participants • Safety Population
|
0 Participants
n=16 Participants • Safety Population
|
1 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
3 Participants
n=21 Participants • Safety Population
|
5 Participants
n=76 Participants • Safety Population
|
|
PAH classification
Open Label Phase · PAH associated with connective tissue disease
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
1 Participants
n=15 Participants • Safety Population
|
0 Participants
n=16 Participants • Safety Population
|
7 Participants
n=22 Participants • Safety Population
|
1 Participants
n=2 Participants • Safety Population
|
2 Participants
n=21 Participants • Safety Population
|
11 Participants
n=76 Participants • Safety Population
|
|
PAH classification
Open Label Phase · PAH associated with congenital systemic pulmonary shunt
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
1 Participants
n=15 Participants • Safety Population
|
2 Participants
n=16 Participants • Safety Population
|
2 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
5 Participants
n=21 Participants • Safety Population
|
10 Participants
n=76 Participants • Safety Population
|
|
Number of PAH therapies category
Double Blind Phase · 1 PAH therapy
|
5 Participants
n=36 Participants • Safety Population
|
6 Participants
n=36 Participants • Safety Population
|
6 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
17 Participants
n=108 Participants • Safety Population
|
|
Number of PAH therapies category
Double Blind Phase · 2 PAH therapies
|
12 Participants
n=36 Participants • Safety Population
|
12 Participants
n=36 Participants • Safety Population
|
11 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
35 Participants
n=108 Participants • Safety Population
|
|
Number of PAH therapies category
Double Blind Phase · 3 PAH therapies
|
19 Participants
n=36 Participants • Safety Population
|
18 Participants
n=36 Participants • Safety Population
|
19 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
56 Participants
n=108 Participants • Safety Population
|
|
Number of PAH therapies category
Open Label Phase · 1 PAH therapy
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
3 Participants
n=15 Participants • Safety Population
|
3 Participants
n=16 Participants • Safety Population
|
3 Participants
n=22 Participants • Safety Population
|
1 Participants
n=2 Participants • Safety Population
|
4 Participants
n=21 Participants • Safety Population
|
14 Participants
n=76 Participants • Safety Population
|
|
Number of PAH therapies category
Open Label Phase · 2 PAH therapies
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
4 Participants
n=15 Participants • Safety Population
|
5 Participants
n=16 Participants • Safety Population
|
10 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
6 Participants
n=21 Participants • Safety Population
|
25 Participants
n=76 Participants • Safety Population
|
|
Number of PAH therapies category
Open Label Phase · 3 PAH therapies
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
8 Participants
n=15 Participants • Safety Population
|
8 Participants
n=16 Participants • Safety Population
|
9 Participants
n=22 Participants • Safety Population
|
1 Participants
n=2 Participants • Safety Population
|
11 Participants
n=21 Participants • Safety Population
|
37 Participants
n=76 Participants • Safety Population
|
|
Baseline use of selexipag
Double Blind Phase · Yes
|
8 Participants
n=36 Participants • Safety Population
|
9 Participants
n=36 Participants • Safety Population
|
8 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
25 Participants
n=108 Participants • Safety Population
|
|
Baseline use of selexipag
Double Blind Phase · No
|
28 Participants
n=36 Participants • Safety Population
|
27 Participants
n=36 Participants • Safety Population
|
28 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
83 Participants
n=108 Participants • Safety Population
|
|
Baseline use of selexipag
Open Label Phase · Yes
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
2 Participants
n=15 Participants • Safety Population
|
3 Participants
n=16 Participants • Safety Population
|
2 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
5 Participants
n=21 Participants • Safety Population
|
12 Participants
n=76 Participants • Safety Population
|
|
Baseline use of selexipag
Open Label Phase · No
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
13 Participants
n=15 Participants • Safety Population
|
13 Participants
n=16 Participants • Safety Population
|
20 Participants
n=22 Participants • Safety Population
|
2 Participants
n=2 Participants • Safety Population
|
16 Participants
n=21 Participants • Safety Population
|
64 Participants
n=76 Participants • Safety Population
|
|
Baseline use of parenteral prostacyclin
Double Blind Phase · Yes
|
13 Participants
n=36 Participants • Safety Population
|
11 Participants
n=36 Participants • Safety Population
|
14 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
38 Participants
n=108 Participants • Safety Population
|
|
Baseline use of parenteral prostacyclin
Double Blind Phase · No
|
23 Participants
n=36 Participants • Safety Population
|
25 Participants
n=36 Participants • Safety Population
|
22 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
70 Participants
n=108 Participants • Safety Population
|
|
Baseline use of parenteral prostacyclin
Open Label Phase · Yes
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
8 Participants
n=15 Participants • Safety Population
|
6 Participants
n=16 Participants • Safety Population
|
9 Participants
n=22 Participants • Safety Population
|
1 Participants
n=2 Participants • Safety Population
|
7 Participants
n=21 Participants • Safety Population
|
31 Participants
n=76 Participants • Safety Population
|
|
Baseline use of parenteral prostacyclin
Open Label Phase · No
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
7 Participants
n=15 Participants • Safety Population
|
10 Participants
n=16 Participants • Safety Population
|
13 Participants
n=22 Participants • Safety Population
|
1 Participants
n=2 Participants • Safety Population
|
14 Participants
n=21 Participants • Safety Population
|
45 Participants
n=76 Participants • Safety Population
|
|
Baseline use of endothelin receptor antagonist
Double Blind Phase · Yes
|
30 Participants
n=36 Participants • Safety Population
|
30 Participants
n=36 Participants • Safety Population
|
29 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
89 Participants
n=108 Participants • Safety Population
|
|
Baseline use of endothelin receptor antagonist
Double Blind Phase · No
|
6 Participants
n=36 Participants • Safety Population
|
6 Participants
n=36 Participants • Safety Population
|
7 Participants
n=36 Participants • Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
19 Participants
n=108 Participants • Safety Population
|
|
Baseline use of endothelin receptor antagonist
Open Label Phase · Yes
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
11 Participants
n=15 Participants • Safety Population
|
13 Participants
n=16 Participants • Safety Population
|
17 Participants
n=22 Participants • Safety Population
|
2 Participants
n=2 Participants • Safety Population
|
16 Participants
n=21 Participants • Safety Population
|
59 Participants
n=76 Participants • Safety Population
|
|
Baseline use of endothelin receptor antagonist
Open Label Phase · No
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
0 Participants
Safety Population
|
4 Participants
n=15 Participants • Safety Population
|
3 Participants
n=16 Participants • Safety Population
|
5 Participants
n=22 Participants • Safety Population
|
0 Participants
n=2 Participants • Safety Population
|
5 Participants
n=21 Participants • Safety Population
|
17 Participants
n=76 Participants • Safety Population
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: ITT population
Pulmonary vascular resistance (PVR) was measured by right heart catheterization (RHC)
Outcome measures
| Measure |
Rodatristat Ethyl 300 mg BID
n=36 Participants
MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks
|
Rodatristat Ethyl 600 mg BID
n=36 Participants
MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks
|
Placebo
n=36 Participants
MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks
|
|---|---|---|---|
|
Percent Change From Baseline of Pulmonary Vascular Resistance (PVR) at Week 24
|
63.083 percent
Standard Error 18.529
|
64.219 percent
Standard Error 18.013
|
5.813 percent
Standard Error 18.052
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: ITT population
PAH functional disease severity is classified in 4 classes (I to IV) according to World Health Organization (WHO). I:Patients with pulmonary hypertension (PH) but without resulting limitation of physical act.Ordinary physical act does not cause undue dyspnea,fatigue,chest pain,near syncope. II:Patients with PH with slight limitation of physical act.Ordinary physical act causes undue dyspnea or fatigue, chest pain,or near syncope. III:Patients with PH with marked limitation of physical act.Less than ordinary act causes undue dyspnea or fatigue,chest pain,or near syncope. IV:Patients with PH with inability to carry out any physical act without symptoms,manifest signs of right-heart failure.Dyspnea and/or fatigue may even be present at rest.Discomfort is increased by physical act -II, -I:Patients condition improved at WK24 compared with baseline II, I:Patients condition worsened at WK24 compared with baseline No change:Patients condition not changes at WK24 compare with baseline
Outcome measures
| Measure |
Rodatristat Ethyl 300 mg BID
n=36 Participants
MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks
|
Rodatristat Ethyl 600 mg BID
n=36 Participants
MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks
|
Placebo
n=36 Participants
MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in World Health Organization (WHO) Functional Class (FC)
-II
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in World Health Organization (WHO) Functional Class (FC)
-I
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Change From Baseline in World Health Organization (WHO) Functional Class (FC)
No Change
|
30 Participants
|
30 Participants
|
30 Participants
|
|
Change From Baseline in World Health Organization (WHO) Functional Class (FC)
I
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Change From Baseline in World Health Organization (WHO) Functional Class (FC)
II
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: ITT population
The six-minute walk distance (6MWD) is a simple, commonly used, standardized measure of functional exercise capacity and endurance. It is a commonly used measure of efficacy in PAH clinical studies.
Outcome measures
| Measure |
Rodatristat Ethyl 300 mg BID
n=36 Participants
MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks
|
Rodatristat Ethyl 600 mg BID
n=36 Participants
MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks
|
Placebo
n=36 Participants
MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Six-minute Walk Distance (6MWD)
|
-14.5 six-minute walk distance (6MWD) (meters)
Interval -31.5 to 28.0
|
0 six-minute walk distance (6MWD) (meters)
Interval -27.5 to 20.0
|
2.5 six-minute walk distance (6MWD) (meters)
Interval -13.5 to 23.0
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: ITT population
N-terminal prohormone of brain natriuretic peptide (NT-proBNP) is a strong predictor of disease progression and mortality in PAH patients. Current PAH treatment guidelines recommend measurement of NT-proBNP levels for both risk assessment and longitudinal follow up. NT-proBNP levels are also a good marker of response to treatment.
Outcome measures
| Measure |
Rodatristat Ethyl 300 mg BID
n=36 Participants
MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks
|
Rodatristat Ethyl 600 mg BID
n=36 Participants
MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks
|
Placebo
n=36 Participants
MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Levels
|
1145.7 pg/mL
Standard Error 325.93
|
886.1 pg/mL
Standard Error 275.70
|
19.8 pg/mL
Standard Error 143.86
|
Adverse Events
Rodatristat Ethyl 300 mg BID
Serious events: 9 serious events
Other events: 32 other events
Deaths: 1 deaths
Rodatristat Ethyl 600 mg BID
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo-Rodatristat Ethyl 300 mg
Serious events: 2 serious events
Other events: 12 other events
Deaths: 2 deaths
Placebo-Rodatristat Ethyl 600 mg
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 300 mg
Serious events: 6 serious events
Other events: 12 other events
Deaths: 0 deaths
Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 600 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Rodatristat Ethyl 600 Mg-Rodatristat Ethyl 600 mg
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rodatristat Ethyl 300 mg BID
n=36 participants at risk
MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks
|
Rodatristat Ethyl 600 mg BID
n=36 participants at risk
MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks
|
Placebo
n=36 participants at risk
MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks
|
Placebo-Rodatristat Ethyl 300 mg
n=15 participants at risk
Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase
|
Placebo-Rodatristat Ethyl 600 mg
n=16 participants at risk
Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase
|
Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 300 mg
n=22 participants at risk
Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase
|
Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 600 mg
n=2 participants at risk
Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase
|
Rodatristat Ethyl 600 Mg-Rodatristat Ethyl 600 mg
n=21 participants at risk
Subjects whose actual treatment group is Rodatristat ethyl two 600 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
13.3%
2/15 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.1%
2/22 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Cardiac disorders
Right ventricular failure
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.1%
2/22 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Cardiac disorders
Angina pectoris
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Cardiac disorders
Atrial fibrillation
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Cardiac disorders
Myocardial infarction
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Device related infection
|
2.8%
1/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Influenza
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Pneumonia influenzal
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Septic shock
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Nervous system disorders
Syncope
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Nervous system disorders
Presyncope
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Nervous system disorders
Seizure
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
General disorders
Device related thrombosis
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
Transplant evaluation
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
General disorders
Pyrexia
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Product Issues
Device extrusion
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Product Issues
Device breakage
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Product Issues
Device malfunction
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
Other adverse events
| Measure |
Rodatristat Ethyl 300 mg BID
n=36 participants at risk
MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks
|
Rodatristat Ethyl 600 mg BID
n=36 participants at risk
MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks
|
Placebo
n=36 participants at risk
MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks
|
Placebo-Rodatristat Ethyl 300 mg
n=15 participants at risk
Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase
|
Placebo-Rodatristat Ethyl 600 mg
n=16 participants at risk
Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase
|
Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 300 mg
n=22 participants at risk
Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase
|
Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 600 mg
n=2 participants at risk
Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase
|
Rodatristat Ethyl 600 Mg-Rodatristat Ethyl 600 mg
n=21 participants at risk
Subjects whose actual treatment group is Rodatristat ethyl two 600 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
13.9%
5/36 • Number of events 5 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
8.3%
3/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
22.2%
8/36 • Number of events 8 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
20.0%
3/15 • Number of events 5 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
43.8%
7/16 • Number of events 8 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
22.7%
5/22 • Number of events 5 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
50.0%
1/2 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
28.6%
6/21 • Number of events 6 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
8.3%
3/36 • Number of events 4 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Respiratory tract infection
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
13.3%
2/15 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Influenza
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Respiratory tract infection viral
|
8.3%
3/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.5%
2/21 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Urinary tract infection bacterial
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.1%
2/22 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Urinary tract infection
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Infusion site infection
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
2/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
50.0%
1/2 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
3/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
13.6%
3/22 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.6%
2/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
8.3%
3/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.5%
2/21 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.6%
2/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Metabolism and nutrition disorders
Fluid overload
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.1%
2/22 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
11.1%
4/36 • Number of events 4 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
8.3%
3/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
8.3%
3/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
14.3%
3/21 • Number of events 4 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Nervous system disorders
Dizziness
|
8.3%
3/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
8.3%
3/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
13.9%
5/36 • Number of events 5 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
13.3%
2/15 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.1%
2/22 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
50.0%
1/2 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Nervous system disorders
Headache
|
8.3%
3/36 • Number of events 4 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
8.3%
3/36 • Number of events 4 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
50.0%
1/2 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
14.3%
3/21 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Nervous system disorders
Syncope
|
8.3%
3/36 • Number of events 4 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.5%
2/21 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
50.0%
1/2 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Cardiac disorders
Palpitations
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
13.9%
5/36 • Number of events 5 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Cardiac disorders
Right ventricular failure
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
12.5%
2/16 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Cardiac disorders
Sinus tachycardia
|
5.6%
2/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.1%
2/22 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
50.0%
1/2 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.9%
5/36 • Number of events 6 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
11.1%
4/36 • Number of events 6 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.5%
2/21 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
11.1%
4/36 • Number of events 4 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
11.1%
4/36 • Number of events 4 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
13.3%
2/15 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
14.3%
3/21 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
8.3%
3/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.1%
2/22 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
9/36 • Number of events 11 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
47.2%
17/36 • Number of events 24 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
11.1%
4/36 • Number of events 5 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
13.3%
2/15 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
37.5%
6/16 • Number of events 11 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
14.3%
3/21 • Number of events 4 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Nausea
|
30.6%
11/36 • Number of events 14 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
36.1%
13/36 • Number of events 17 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
8.3%
3/36 • Number of events 4 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
20.0%
3/15 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
18.8%
3/16 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
18.2%
4/22 • Number of events 4 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
50.0%
1/2 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.5%
2/21 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
4/36 • Number of events 5 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
22.2%
8/36 • Number of events 9 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
13.3%
2/15 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
31.2%
5/16 • Number of events 7 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.1%
2/22 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
23.8%
5/21 • Number of events 5 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
3/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
11.1%
4/36 • Number of events 5 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
11.1%
4/36 • Number of events 4 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Constipation
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
8.3%
3/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
50.0%
1/2 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 5 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
12.5%
2/16 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
18.8%
3/16 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.5%
2/21 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Flatulence
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
50.0%
1/2 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
2/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.5%
2/21 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
General disorders
Fatigue
|
13.9%
5/36 • Number of events 5 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
8.3%
3/36 • Number of events 4 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
General disorders
Pain
|
8.3%
3/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.1%
2/22 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
General disorders
Oedema peripheral
|
11.1%
4/36 • Number of events 6 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
General disorders
Pyrexia
|
8.3%
3/36 • Number of events 6 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
General disorders
Asthenia
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
General disorders
Chest discomfort
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
5.6%
2/36 • Number of events 4 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
General disorders
Non-cardiac chest pain
|
5.6%
2/36 • Number of events 4 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
General disorders
Adverse drug reaction
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
General disorders
Peripheral swelling
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
General disorders
Device related thrombosis
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
50.0%
1/2 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
General disorders
Lithiasis
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
Gamma-glutamyltransferase increased
|
38.9%
14/36 • Number of events 26 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
30.6%
11/36 • Number of events 20 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
26.7%
4/15 • Number of events 10 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
43.8%
7/16 • Number of events 18 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
13.6%
3/22 • Number of events 7 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
14.3%
3/21 • Number of events 6 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
Aspartate aminotransferase increased
|
13.9%
5/36 • Number of events 6 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
11.1%
4/36 • Number of events 5 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.1%
2/22 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
4/36 • Number of events 4 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
8.3%
3/36 • Number of events 4 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
12.5%
2/16 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.1%
2/22 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
Anticoagulation drug level below therapeutic
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
3/36 • Number of events 5 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
Platelet count decreased
|
5.6%
2/36 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
White blood cell count decreased
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
Blood pH increased
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
50.0%
1/2 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
50.0%
1/2 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Investigations
Weight decreased
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
8.3%
3/36 • Number of events 3 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Ear and labyrinth disorders
Vertigo
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
2.8%
1/36 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.2%
1/16 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.5%
1/22 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Vascular disorders
Hypotension
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
9.1%
2/22 • Number of events 2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
4.8%
1/21 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Hepatobiliary disorders
Congestive hepatopathy
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
50.0%
1/2 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
6.7%
1/15 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/2 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
50.0%
1/2 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/36 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/15 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/16 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/22 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
50.0%
1/2 • Number of events 1 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
0.00%
0/21 • Up to 48 weeks
An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER