Trial Outcomes & Findings for Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C) (NCT NCT03596905)
NCT ID: NCT03596905
Last Updated: 2025-12-31
Results Overview
Weekly SBM rate computed for each week
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
218 participants
Primary outcome timeframe
Baseline to Week 4
Results posted on
2025-12-31
Participant Flow
Participant milestones
| Measure |
0.5 mg Plecanatide
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
Plecanatide: Taken orally daily for 4 weeks
|
1.0 mg Plecanatide - Group A
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Matching Placebo - Group A
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
1.0 mg Plecanatide - Group B
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: 12 to18 years old
|
2.0 mg Plecanatide
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
Plecanatide: Taken orally daily for 4 weeks
|
3.0 mg Plecanatide
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
Plecanatide: Taken orally daily for 4 weeks
|
Matching Placebo - Group B
Matching placebo tablets orally daily for 4 weeks Group B - 12 to 18 years old
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
29
|
34
|
32
|
32
|
32
|
|
Overall Study
COMPLETED
|
29
|
26
|
28
|
34
|
27
|
31
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
1
|
0
|
5
|
1
|
3
|
Reasons for withdrawal
| Measure |
0.5 mg Plecanatide
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
Plecanatide: Taken orally daily for 4 weeks
|
1.0 mg Plecanatide - Group A
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Matching Placebo - Group A
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
1.0 mg Plecanatide - Group B
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: 12 to18 years old
|
2.0 mg Plecanatide
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
Plecanatide: Taken orally daily for 4 weeks
|
3.0 mg Plecanatide
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
Plecanatide: Taken orally daily for 4 weeks
|
Matching Placebo - Group B
Matching placebo tablets orally daily for 4 weeks Group B - 12 to 18 years old
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
0
|
2
|
0
|
0
|
|
Overall Study
Participant moved and was unable to complete study
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Non-Compliance with eDiary
|
1
|
0
|
0
|
0
|
1
|
0
|
2
|
|
Overall Study
Non-Compliance with Study Drug
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)
Baseline characteristics by cohort
| Measure |
0.5 mg Plecanatide
n=30 Participants
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
|
1.0 mg Plecanatide - Group A
n=29 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Matching Placebo - Group A
n=29 Participants
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
1.0 mg Plecanatide - Group B
n=34 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: 12 to 18 years old
|
2.0 mg Plecanatide
n=32 Participants
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
3.0 mg Plecanatide
n=32 Participants
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Matching Placebo - Group B
n=32 Participants
Matching placebo Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Age Group · Group A: Age 6 to 11
|
30 Participants
n=1000 Participants
|
29 Participants
n=1986 Participants
|
29 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
88 Participants
n=6 Participants
|
|
Age, Customized
Age Group · Group B: Age 12 to <18
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
34 Participants
n=4994 Participants
|
32 Participants
n=62 Participants
|
32 Participants
n=357 Participants
|
32 Participants
n=6 Participants
|
130 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=1000 Participants
|
15 Participants
n=1986 Participants
|
15 Participants
n=2008 Participants
|
20 Participants
n=4994 Participants
|
20 Participants
n=62 Participants
|
20 Participants
n=357 Participants
|
20 Participants
n=6 Participants
|
126 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=1000 Participants
|
14 Participants
n=1986 Participants
|
14 Participants
n=2008 Participants
|
14 Participants
n=4994 Participants
|
12 Participants
n=62 Participants
|
12 Participants
n=357 Participants
|
12 Participants
n=6 Participants
|
92 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
1 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
1 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=1000 Participants
|
2 Participants
n=1986 Participants
|
5 Participants
n=2008 Participants
|
6 Participants
n=4994 Participants
|
6 Participants
n=62 Participants
|
2 Participants
n=357 Participants
|
2 Participants
n=6 Participants
|
27 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=1000 Participants
|
27 Participants
n=1986 Participants
|
22 Participants
n=2008 Participants
|
28 Participants
n=4994 Participants
|
25 Participants
n=62 Participants
|
30 Participants
n=357 Participants
|
30 Participants
n=6 Participants
|
188 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=1000 Participants
|
27 Participants
n=1986 Participants
|
23 Participants
n=2008 Participants
|
25 Participants
n=4994 Participants
|
24 Participants
n=62 Participants
|
27 Participants
n=357 Participants
|
28 Participants
n=6 Participants
|
177 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=1000 Participants
|
2 Participants
n=1986 Participants
|
6 Participants
n=2008 Participants
|
9 Participants
n=4994 Participants
|
8 Participants
n=62 Participants
|
5 Participants
n=357 Participants
|
4 Participants
n=6 Participants
|
41 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=1000 Participants
|
29 Participants
n=1986 Participants
|
29 Participants
n=2008 Participants
|
34 Participants
n=4994 Participants
|
32 Participants
n=62 Participants
|
32 Participants
n=357 Participants
|
32 Participants
n=6 Participants
|
218 Participants
n=6 Participants
|
|
Height at Screening (m)
|
1.37 meters
STANDARD_DEVIATION 0.136 • n=1000 Participants
|
1.36 meters
STANDARD_DEVIATION 0.135 • n=1986 Participants
|
1.38 meters
STANDARD_DEVIATION 0.131 • n=2008 Participants
|
1.63 meters
STANDARD_DEVIATION 0.091 • n=4994 Participants
|
1.60 meters
STANDARD_DEVIATION 0.097 • n=62 Participants
|
1.58 meters
STANDARD_DEVIATION 0.079 • n=357 Participants
|
1.63 meters
STANDARD_DEVIATION 0.086 • n=6 Participants
|
1.51 meters
STANDARD_DEVIATION 0.159 • n=6 Participants
|
|
Weight at Screening
|
37.53 kilograms
STANDARD_DEVIATION 11.980 • n=1000 Participants
|
39.55 kilograms
STANDARD_DEVIATION 15.118 • n=1986 Participants
|
38.79 kilograms
STANDARD_DEVIATION 17.070 • n=2008 Participants
|
66.35 kilograms
STANDARD_DEVIATION 22.402 • n=4994 Participants
|
60.72 kilograms
STANDARD_DEVIATION 14.050 • n=62 Participants
|
58.21 kilograms
STANDARD_DEVIATION 16.223 • n=357 Participants
|
63.60 kilograms
STANDARD_DEVIATION 16.62 • n=6 Participants
|
52.73 kilograms
STANDARD_DEVIATION 20.231 • n=6 Participants
|
|
BMI at Screening
|
19.82 kg/m^2
STANDARD_DEVIATION 4.961 • n=1000 Participants
|
20.87 kg/m^2
STANDARD_DEVIATION 6.678 • n=1986 Participants
|
19.64 kg/m^2
STANDARD_DEVIATION 5.590 • n=2008 Participants
|
24.85 kg/m^2
STANDARD_DEVIATION 7.129 • n=4994 Participants
|
23.66 kg/m^2
STANDARD_DEVIATION 4.460 • n=62 Participants
|
23.26 kg/m^2
STANDARD_DEVIATION 6.230 • n=357 Participants
|
23.74 kg/m^2
STANDARD_DEVIATION 4.867 • n=6 Participants
|
22.385 kg/m^2
STANDARD_DEVIATION 6.035 • n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4Weekly SBM rate computed for each week
Outcome measures
| Measure |
Experimental: 0.5 mg plecanatide
n=30 Participants
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group A
n=28 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Matching placebo - Group A
n=29 Participants
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group B
n=34 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: 12 to18 years old
|
Experimental: 2.0 mg plecanatide
n=32 Participants
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Experimental: 3.0 mg plecanatide
n=32 Participants
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Matching Placebo - Group B
n=32 Participants
Matching placebo Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups
|
0.6 Number of SBMs per week
Standard Deviation 2.24 • Interval -0.86 to 0.9
|
0.8 Number of SBMs per week
Standard Deviation 1.75 • Interval -0.65 to 1.17
|
0.6 Number of SBMs per week
Standard Deviation 1.53
|
1.0 Number of SBMs per week
Standard Deviation 2.08 • Interval -0.06 to 1.87
|
1.1 Number of SBMs per week
Standard Deviation 2.20 • Interval 0.05 to 2.01
|
.70 Number of SBMs per week
Standard Deviation 2.45 • Interval -0.28 to 1.67
|
-0.2 Number of SBMs per week
Standard Deviation 1.95
|
SECONDARY outcome
Timeframe: Baseline to Week 4Weekly frequency was calculated as the number of abdominal pain episodes and abdominal discomfort episodes per week, based on daily diary entries. Baseline was the average weekly frequency during the 2-week baseline assessment period. Values shown are mean change from baseline (SD).
Outcome measures
| Measure |
Experimental: 0.5 mg plecanatide
n=30 Participants
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group A
n=28 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Matching placebo - Group A
n=29 Participants
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group B
n=34 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: 12 to18 years old
|
Experimental: 2.0 mg plecanatide
n=32 Participants
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Experimental: 3.0 mg plecanatide
n=32 Participants
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Matching Placebo - Group B
n=32 Participants
Matching placebo Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Frequency of Abdominal Pain and Abdominal Discomfort Over the 4-week Treatment Period Compared to Placebo and Across Treatment Groups..
Frequency of Abdominal Pain
|
-2.7 Episodes per week
Standard Deviation 2.27
|
-2.2 Episodes per week
Standard Deviation 2.38
|
-1.4 Episodes per week
Standard Deviation 2.47
|
-1.3 Episodes per week
Standard Deviation 1.49
|
-1.6 Episodes per week
Standard Deviation 2.34
|
-1.4 Episodes per week
Standard Deviation 2.26
|
-1.6 Episodes per week
Standard Deviation 2.56
|
|
Change From Baseline in Frequency of Abdominal Pain and Abdominal Discomfort Over the 4-week Treatment Period Compared to Placebo and Across Treatment Groups..
Frequency of Abdominal Discomfort
|
-2.5 Episodes per week
Standard Deviation 2.18
|
-2.1 Episodes per week
Standard Deviation 2.35
|
-1.3 Episodes per week
Standard Deviation 2.44
|
-0.9 Episodes per week
Standard Deviation 1.59
|
-1.5 Episodes per week
Standard Deviation 2.22
|
-1.1 Episodes per week
Standard Deviation 2.03
|
-1.3 Episodes per week
Standard Deviation 2.43
|
SECONDARY outcome
Timeframe: Baseline to Week 4Severity of abdominal pain and abdominal discomfort was recorded daily using an electronic diary on a 0-10 numeric rating scale (0 = no pain/discomfort; 10 = worst possible). Weekly averages were calculated; baseline was the average score during the 2-week baseline period. Values shown are mean change from baseline.
Outcome measures
| Measure |
Experimental: 0.5 mg plecanatide
n=30 Participants
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group A
n=28 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Matching placebo - Group A
n=29 Participants
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group B
n=34 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: 12 to18 years old
|
Experimental: 2.0 mg plecanatide
n=32 Participants
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Experimental: 3.0 mg plecanatide
n=32 Participants
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Matching Placebo - Group B
n=32 Participants
Matching placebo Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Severity of Abdominal Pain and Abdominal Discomfort Over the 4-week Treatment Period Compared to Placebo and Across Treatment Groups..
Severity of Abdominal Pain
|
-3.3 Severity score (0-10 scale)
Standard Deviation 3.07 • Interval -1.39 to 0.88
|
-2.3 Severity score (0-10 scale)
Standard Deviation 2.72 • Interval -0.62 to 1.69
|
-2.3 Severity score (0-10 scale)
Standard Deviation 2.33
|
-2.2 Severity score (0-10 scale)
Standard Deviation 2.37 • Interval -1.09 to 0.77
|
-2.8 Severity score (0-10 scale)
Standard Deviation 2.19 • Interval -1.7 to 0.2
|
-2.56 Severity score (0-10 scale)
Standard Deviation 2.27 • Interval -1.22 to 0.67
|
-2 Severity score (0-10 scale)
Standard Deviation 2.36
|
|
Change From Baseline in Severity of Abdominal Pain and Abdominal Discomfort Over the 4-week Treatment Period Compared to Placebo and Across Treatment Groups..
Severity of Abdominal Discomfort
|
-3.4 Severity score (0-10 scale)
Standard Deviation 2.97 • Interval -2.24 to 0.18
|
-2.4 Severity score (0-10 scale)
Standard Deviation 2.83 • Interval -1.25 to 1.22
|
-2.40 Severity score (0-10 scale)
Standard Deviation 2.51
|
-1.9 Severity score (0-10 scale)
Standard Deviation 2.58 • Interval -1.0 to 1.01
|
-3.0 Severity score (0-10 scale)
Standard Deviation 2.23 • Interval -1.97 to 0.1
|
-2.5 Severity score (0-10 scale)
Standard Deviation 2.36 • Interval -1.47 to 0.58
|
-2.0 Severity score (0-10 scale)
Standard Deviation 2.46
|
SECONDARY outcome
Timeframe: Baseline to Week 6Weekly frequency of complete spontaneous bowel movements (CSBMs) was calculated based on daily diary entries. Baseline was the average weekly frequency during the 2-week baseline period. Values shown are mean change from baseline (SD) at end of 4 weeks of study.
Outcome measures
| Measure |
Experimental: 0.5 mg plecanatide
n=30 Participants
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group A
n=28 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Matching placebo - Group A
n=29 Participants
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group B
n=34 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: 12 to18 years old
|
Experimental: 2.0 mg plecanatide
n=32 Participants
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Experimental: 3.0 mg plecanatide
n=32 Participants
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Matching Placebo - Group B
n=32 Participants
Matching placebo Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Frequency of Complete Spontaneous Bowel Movements (CSBM)
|
0.7 Change in Number of CSBMs per week
Standard Deviation 1.73
|
0.2 Change in Number of CSBMs per week
Standard Deviation 0.75
|
0.2 Change in Number of CSBMs per week
Standard Deviation 0.91
|
0.4 Change in Number of CSBMs per week
Standard Deviation 0.85
|
0.1 Change in Number of CSBMs per week
Standard Deviation 1.07
|
0.7 Change in Number of CSBMs per week
Standard Deviation 1.79
|
-0.1 Change in Number of CSBMs per week
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Baseline to Week 4Weekly frequency of bowel movements (BMs) was calculated based on daily diary entries. Baseline was the average weekly frequency during the 2-week baseline period. Values shown are mean change from baseline (SD).
Outcome measures
| Measure |
Experimental: 0.5 mg plecanatide
n=30 Participants
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group A
n=28 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Matching placebo - Group A
n=29 Participants
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group B
n=34 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: 12 to18 years old
|
Experimental: 2.0 mg plecanatide
n=32 Participants
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Experimental: 3.0 mg plecanatide
n=32 Participants
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Matching Placebo - Group B
n=32 Participants
Matching placebo Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Frequency of Bowel Movements (BM)
|
0.5 Number of BMs per week
Standard Deviation 2.24
|
0.8 Number of BMs per week
Standard Deviation 1.7
|
0.6 Number of BMs per week
Standard Deviation 1.52
|
0.8 Number of BMs per week
Standard Deviation 2.06
|
1.0 Number of BMs per week
Standard Deviation 2.23
|
0.8 Number of BMs per week
Standard Deviation 2.263
|
0 Number of BMs per week
Standard Deviation 2.05
|
SECONDARY outcome
Timeframe: Day 1 to first BM during Treatment PeriodThis outcome was analyzed as a time-to-event variable (time to first complete spontaneous bowel movement), and confidence intervals were estimated using Kaplan-Meier methods.
Outcome measures
| Measure |
Experimental: 0.5 mg plecanatide
n=30 Participants
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group A
n=28 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Matching placebo - Group A
n=29 Participants
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group B
n=34 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: 12 to18 years old
|
Experimental: 2.0 mg plecanatide
n=32 Participants
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Experimental: 3.0 mg plecanatide
n=32 Participants
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Matching Placebo - Group B
n=32 Participants
Matching placebo Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
|---|---|---|---|---|---|---|---|
|
Time to First Bowl Movement (in Days)
|
4.1 Days
Interval 1.13 to 11.43
|
2.58 Days
Interval 1.56 to 6.21
|
5.35 Days
Interval 2.35 to
The upper confidence limit could not be estimated because the time-to-event distribution did not contain a sufficient number of events beyond the median to support calculation of the upper confidence interval.
|
1.68 Days
Interval 0.99 to 5.23
|
2.05 Days
Interval 0.86 to 6.25
|
2.57 Days
Interval 0.89 to 8.15
|
2.69 Days
Interval 1.35 to 5.28
|
SECONDARY outcome
Timeframe: Baseline to Week 4Weekly stool consistency scores based on BSFS (≥12 years) or mBSFS-C (6-11 years). BSFS Scale is a 7 point scale, from Type 1 (Hard to pass) to Type 7 (entirely liquid). mBSFS-C is a 5 point scale, from Type 1 (hard to pass) to Type 5 (watery, no solid pieces).
Outcome measures
| Measure |
Experimental: 0.5 mg plecanatide
n=30 Participants
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group A
n=28 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Matching placebo - Group A
n=29 Participants
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group B
n=34 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: 12 to18 years old
|
Experimental: 2.0 mg plecanatide
n=32 Participants
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Experimental: 3.0 mg plecanatide
n=32 Participants
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Matching Placebo - Group B
n=32 Participants
Matching placebo Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Stool Consistency (Based on Bristol Stool Form Scale, BSFS or Modified Bristol Stool Form Scale for Children, mBSFS-C)
|
1.2 Score (BSFS or mBSFS-C)
Standard Deviation 1.12
|
0.8 Score (BSFS or mBSFS-C)
Standard Deviation 1.18
|
1.2 Score (BSFS or mBSFS-C)
Standard Deviation 0.72
|
1.1 Score (BSFS or mBSFS-C)
Standard Deviation 1.24
|
1.4 Score (BSFS or mBSFS-C)
Standard Deviation 1.5
|
1.9 Score (BSFS or mBSFS-C)
Standard Deviation 1.35
|
0.7 Score (BSFS or mBSFS-C)
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: Baseline to Week 4Number of rescue medication tablets (Dulcolax® 5 mg) used during the 4-week treatment period. Subjects were instructed to use rescue medication only if ≥72 hours had passed since last bowel movement.
Outcome measures
| Measure |
Experimental: 0.5 mg plecanatide
n=30 Participants
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group A
n=28 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Matching placebo - Group A
n=29 Participants
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group B
n=34 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: 12 to18 years old
|
Experimental: 2.0 mg plecanatide
n=32 Participants
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Experimental: 3.0 mg plecanatide
n=32 Participants
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Matching Placebo - Group B
n=32 Participants
Matching placebo Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
|---|---|---|---|---|---|---|---|
|
Use of Rescue Medication
|
1.3 Number of Tablets
Standard Deviation 3.6
|
0.7 Number of Tablets
Standard Deviation 3.22
|
0.4 Number of Tablets
Standard Deviation 1.18
|
2.4 Number of Tablets
Standard Deviation 8.73
|
0.2 Number of Tablets
Standard Deviation 0.59
|
1.6 Number of Tablets
Standard Deviation 5.02
|
2.4 Number of Tablets
Standard Deviation 6.68
|
SECONDARY outcome
Timeframe: Baseline to Week 4Weekly fecal incontinence episodes recorded in daily diary.
Outcome measures
| Measure |
Experimental: 0.5 mg plecanatide
n=30 Participants
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group A
n=28 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Matching placebo - Group A
n=29 Participants
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group B
n=34 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: 12 to18 years old
|
Experimental: 2.0 mg plecanatide
n=32 Participants
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Experimental: 3.0 mg plecanatide
n=32 Participants
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Matching Placebo - Group B
n=32 Participants
Matching placebo Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Frequency of Fecal Incontinence
|
0.3 Number of episodes per week
Standard Deviation 2.10
|
1.9 Number of episodes per week
Standard Deviation 4.36
|
1.1 Number of episodes per week
Standard Deviation 3.04
|
0.9 Number of episodes per week
Standard Deviation 2.58
|
2.3 Number of episodes per week
Standard Deviation 5.33
|
1.0 Number of episodes per week
Standard Deviation 2.73
|
1.3 Number of episodes per week
Standard Deviation 3.29
|
SECONDARY outcome
Timeframe: Baseline to Week 4Severity of abdominal pain scored daily on a 0-10 numeric rating scale (0 = no pain, 10 = worst possible pain). Weekly averages were calculated from daily scores.
Outcome measures
| Measure |
Experimental: 0.5 mg plecanatide
n=30 Participants
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group A
n=28 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Matching placebo - Group A
n=29 Participants
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group B
n=34 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: 12 to18 years old
|
Experimental: 2.0 mg plecanatide
n=32 Participants
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Experimental: 3.0 mg plecanatide
n=32 Participants
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Matching Placebo - Group B
n=32 Participants
Matching placebo Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Severity of Defecation Pain
|
-2.4 Severity Score 0-10 scale
Standard Deviation 3.13
|
-2.6 Severity Score 0-10 scale
Standard Deviation 3.16
|
-2.6 Severity Score 0-10 scale
Standard Deviation 3.62
|
-2.3 Severity Score 0-10 scale
Standard Deviation 2.98
|
-2.5 Severity Score 0-10 scale
Standard Deviation 2.17
|
-1.8 Severity Score 0-10 scale
Standard Deviation 2.7
|
-1.6 Severity Score 0-10 scale
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: All randomized participants who received at least one dose of study drug and had both baseline and post-baseline pain frequency assessments.
Pain with defecation was recorded in daily diaries as the number of episodes per week. Results represent the mean change from baseline in weekly frequency.
Outcome measures
| Measure |
Experimental: 0.5 mg plecanatide
n=30 Participants
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group A
n=28 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Matching placebo - Group A
n=29 Participants
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group B
n=34 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: 12 to18 years old
|
Experimental: 2.0 mg plecanatide
n=32 Participants
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Experimental: 3.0 mg plecanatide
n=32 Participants
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Matching Placebo - Group B
n=32 Participants
Matching placebo Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Frequency of Pain With Defecation
|
-0.3 Change in Episodes per week
Standard Deviation 2.64
|
-0.8 Change in Episodes per week
Standard Deviation 2.97
|
-0.3 Change in Episodes per week
Standard Deviation 2.91
|
0.4 Change in Episodes per week
Standard Deviation 2.33
|
-0.5 Change in Episodes per week
Standard Deviation 2.29
|
-0.8 Change in Episodes per week
Standard Deviation 2.55
|
-0.7 Change in Episodes per week
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: Baseline to Week 4Weekly frequency of large diameter stools recorded in daily diary.
Outcome measures
| Measure |
Experimental: 0.5 mg plecanatide
n=30 Participants
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group A
n=28 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Matching placebo - Group A
n=29 Participants
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg plecanatide - Group B
n=34 Participants
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: 12 to18 years old
|
Experimental: 2.0 mg plecanatide
n=32 Participants
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Experimental: 3.0 mg plecanatide
n=32 Participants
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Matching Placebo - Group B
n=32 Participants
Matching placebo Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Frequency of Large Diameter Stools
|
0 Number of episodes per week
Standard Deviation .28
|
0 Number of episodes per week
Standard Deviation 0.48
|
0.1 Number of episodes per week
Standard Deviation 0.57
|
0.0 Number of episodes per week
Standard Deviation 0.61
|
-0.1 Number of episodes per week
Standard Deviation 0.49
|
0.0 Number of episodes per week
Standard Deviation 0.40
|
0.1 Number of episodes per week
Standard Deviation 0.67
|
Adverse Events
Experimental: 0.5 mg Plecanatide
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental: 1.0 mg Plecanatide - Group A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Matching Placebo - Group A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Experimental: 1.0 mg Plecanatide - Group B
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Experimental: 2.0 mg Plecanatide
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Experimental: 3.0 mg Plecanatide
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Matching Placebo - Group B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental: 0.5 mg Plecanatide
n=30 participants at risk
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg Plecanatide - Group A
n=29 participants at risk
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Matching Placebo - Group A
n=29 participants at risk
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old
|
Experimental: 1.0 mg Plecanatide - Group B
n=34 participants at risk
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: 12 to18 years old
|
Experimental: 2.0 mg Plecanatide
n=32 participants at risk
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Experimental: 3.0 mg Plecanatide
n=32 participants at risk
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
Matching Placebo - Group B
n=32 participants at risk
Matching placebo Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
6.9%
2/29 • Number of events 2 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
2.9%
1/34 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.1%
1/32 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.1%
1/32 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.1%
1/32 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
General disorders
Pyrexia
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.4%
1/29 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/34 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.4%
1/29 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/34 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
1/30 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/34 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
5.9%
2/34 • Number of events 2 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.1%
1/32 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.4%
1/29 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
2.9%
1/34 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.1%
1/32 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.1%
1/32 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.4%
1/29 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.4%
1/29 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
2.9%
1/34 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.1%
1/32 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/34 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.1%
1/32 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/34 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.1%
1/32 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
General disorders
Chest Pain
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
2.9%
1/34 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Infections and infestations
COVID-19
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/34 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.1%
1/32 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/34 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.1%
1/32 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/34 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.1%
1/32 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/34 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.1%
1/32 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
2.9%
1/34 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
2.9%
1/34 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/34 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.1%
1/32 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
2.9%
1/34 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/34 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.1%
1/32 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/34 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
3.1%
1/32 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/30 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/29 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
2.9%
1/34 • Number of events 1 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
0.00%
0/32 • From consent signature until end of study participation, up to 10 weeks. This includes screening, 4-week treatment, and 2-week follow-up periods.
Adverse events were coded using MedDRA Version 24.1. All AEs were collected from consent through final study visit, regardless of relationship to study drug. GI symptoms (e.g., abdominal pain, discomfort, defecation pain) were captured via daily electronic diaries and not separately reported as AEs unless considered bothersome by the subject. Missing severity or relationship values were imputed as "Severe" and "Reasonable Possibility," respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place