Trial Outcomes & Findings for Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d) (NCT NCT01553591)
NCT ID: NCT01553591
Last Updated: 2018-09-04
Results Overview
Composite responders were defined as a participant who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score \<5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1282 participants
Primary outcome timeframe
Up to 12 Weeks
Results posted on
2018-09-04
Participant Flow
Participant milestones
| Measure |
Eluxadoline 75 mg
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
429
|
426
|
427
|
|
Overall Study
Attended Week 12 Visit
|
341
|
330
|
342
|
|
Overall Study
Attended Week 26 Visit
|
289
|
291
|
290
|
|
Overall Study
COMPLETED
|
257
|
257
|
269
|
|
Overall Study
NOT COMPLETED
|
172
|
169
|
158
|
Reasons for withdrawal
| Measure |
Eluxadoline 75 mg
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Overall Study
Voluntarily withdrew
|
94
|
79
|
96
|
|
Overall Study
Adverse Event
|
36
|
45
|
16
|
|
Overall Study
Lost to Follow-up
|
25
|
23
|
16
|
|
Overall Study
Physician decision: other
|
11
|
14
|
16
|
|
Overall Study
Physician decision: lack of efficacy
|
2
|
3
|
7
|
|
Overall Study
Protocol Violation
|
3
|
4
|
4
|
|
Overall Study
Sponsor decision
|
1
|
0
|
3
|
|
Overall Study
Randomized and never dispensed drug
|
0
|
1
|
0
|
Baseline Characteristics
The number analyzed indicates number of participants analyzed for this baseline characteristics.
Baseline characteristics by cohort
| Measure |
Eluxadoline 75 mg
n=429 Participants
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=426 Participants
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 Participants
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
Total
n=1282 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 13.18 • n=429 Participants
|
44.4 years
STANDARD_DEVIATION 13.91 • n=426 Participants
|
45.8 years
STANDARD_DEVIATION 14.10 • n=427 Participants
|
44.9 years
STANDARD_DEVIATION 13.74 • n=1282 Participants
|
|
Age, Customized
18-40 years
|
173 Participants
n=429 Participants
|
166 Participants
n=426 Participants
|
159 Participants
n=427 Participants
|
498 Participants
n=1282 Participants
|
|
Age, Customized
41-64 years
|
227 Participants
n=429 Participants
|
225 Participants
n=426 Participants
|
217 Participants
n=427 Participants
|
669 Participants
n=1282 Participants
|
|
Age, Customized
≥65 years
|
29 Participants
n=429 Participants
|
35 Participants
n=426 Participants
|
51 Participants
n=427 Participants
|
115 Participants
n=1282 Participants
|
|
Sex: Female, Male
Female
|
278 Participants
n=429 Participants
|
283 Participants
n=426 Participants
|
277 Participants
n=427 Participants
|
838 Participants
n=1282 Participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=429 Participants
|
143 Participants
n=426 Participants
|
150 Participants
n=427 Participants
|
444 Participants
n=1282 Participants
|
|
Race/Ethnicity, Customized
White
|
374 Participants
n=429 Participants
|
368 Participants
n=426 Participants
|
370 Participants
n=427 Participants
|
1112 Participants
n=1282 Participants
|
|
Race/Ethnicity, Customized
Black
|
46 Participants
n=429 Participants
|
48 Participants
n=426 Participants
|
46 Participants
n=427 Participants
|
140 Participants
n=1282 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=429 Participants
|
3 Participants
n=426 Participants
|
4 Participants
n=427 Participants
|
10 Participants
n=1282 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=429 Participants
|
2 Participants
n=426 Participants
|
1 Participants
n=427 Participants
|
4 Participants
n=1282 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=429 Participants
|
1 Participants
n=426 Participants
|
0 Participants
n=427 Participants
|
1 Participants
n=1282 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=429 Participants
|
4 Participants
n=426 Participants
|
6 Participants
n=427 Participants
|
15 Participants
n=1282 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
119 Participants
n=429 Participants
|
117 Participants
n=426 Participants
|
125 Participants
n=427 Participants
|
361 Participants
n=1282 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
310 Participants
n=429 Participants
|
309 Participants
n=426 Participants
|
302 Participants
n=427 Participants
|
921 Participants
n=1282 Participants
|
|
Body Mass Index (BMI)
|
30.70 kg/m^2
STANDARD_DEVIATION 7.421 • n=428 Participants • The number analyzed indicates number of participants analyzed for this baseline characteristics.
|
31.22 kg/m^2
STANDARD_DEVIATION 7.858 • n=424 Participants • The number analyzed indicates number of participants analyzed for this baseline characteristics.
|
30.63 kg/m^2
STANDARD_DEVIATION 7.253 • n=425 Participants • The number analyzed indicates number of participants analyzed for this baseline characteristics.
|
30.85 kg/m^2
STANDARD_DEVIATION 7.513 • n=1277 Participants • The number analyzed indicates number of participants analyzed for this baseline characteristics.
|
PRIMARY outcome
Timeframe: Up to 12 WeeksPopulation: Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
Composite responders were defined as a participant who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score \<5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=427 Participants
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=426 Participants
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 Participants
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores
|
23.9 percentage of participants
|
25.1 percentage of participants
|
17.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 26 WeeksPopulation: ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
Composite responders were defined as a participant who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score \<5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=427 Participants
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=426 Participants
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 Participants
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores
|
23.4 percentage of participants
|
29.3 percentage of participants
|
19.0 percentage of participants
|
SECONDARY outcome
Timeframe: 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)Population: ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
Pain responders were defined as participants who met the daily pain response criteria (ie, the worst abdominal pain score in the past 24 hours improved by ≥30% compared to baseline) for at least 50% of days with diary entries during each interval. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=427 Participants
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=426 Participants
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 Participants
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Responders during Weeks 1-12
|
42.4 percentage of participants
|
43.2 percentage of participants
|
39.6 percentage of participants
|
|
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Responders during Weeks 1-26
|
45.2 percentage of participants
|
46.5 percentage of participants
|
43.3 percentage of participants
|
|
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Responders during Weeks 1-4
|
40.5 percentage of participants
|
44.4 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Responders during Weeks 5-8
|
44.5 percentage of participants
|
47.2 percentage of participants
|
45.4 percentage of participants
|
|
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Responders during Weeks 9-12
|
44.5 percentage of participants
|
45.8 percentage of participants
|
43.8 percentage of participants
|
|
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Responders during Weeks 13-16
|
44.3 percentage of participants
|
44.1 percentage of participants
|
45.4 percentage of participants
|
|
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Responders during Weeks 17-20
|
44.7 percentage of participants
|
43.2 percentage of participants
|
41.5 percentage of participants
|
|
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Responders during Weeks 21-24
|
44.7 percentage of participants
|
42.0 percentage of participants
|
38.4 percentage of participants
|
SECONDARY outcome
Timeframe: 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)Population: ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
Stool consistency responders: participants who met daily stool consistency response criterion (ie,score of 1, 2, 3, or 4 or absence of bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain) for at least 50% of days with diary entries during each interval. BSS was defined as 7-point Scale in which score of 1= separate hard lumps, 2= sausage shaped but lumpy, 3= sausage-like with cracks on the surface, 4= sausage-like but smooth and soft, 5= soft blobs with clear cut edges, 6= fluffy pieces with ragged edges, and 7= watery with no solid pieces. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over 12-week interval, and a minimum of 110 days of diary entries over 26-week interval to be a responder.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=427 Participants
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=426 Participants
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 Participants
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Responders during Weeks 1-12
|
30.0 percentage of participants
|
34.3 percentage of participants
|
22.0 percentage of participants
|
|
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Responders during Weeks 1-26
|
28.1 percentage of participants
|
34.0 percentage of participants
|
24.1 percentage of participants
|
|
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Responders during Weeks 1-4
|
28.8 percentage of participants
|
31.5 percentage of participants
|
19.0 percentage of participants
|
|
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Responders during Weeks 5-8
|
31.1 percentage of participants
|
35.2 percentage of participants
|
24.1 percentage of participants
|
|
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Responders during Weeks 9-12
|
29.0 percentage of participants
|
35.2 percentage of participants
|
24.6 percentage of participants
|
|
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Responders during Weeks 13-16
|
27.6 percentage of participants
|
32.9 percentage of participants
|
24.4 percentage of participants
|
|
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Responders during Weeks 17-20
|
31.9 percentage of participants
|
31.5 percentage of participants
|
23.7 percentage of participants
|
|
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Responders during Weeks 21-24
|
30.2 percentage of participants
|
30.3 percentage of participants
|
24.4 percentage of participants
|
SECONDARY outcome
Timeframe: 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)Population: ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
IBS-d global symptom responders were defined as those participants who met the daily IBS-d global symptom response criteria (ie, IBS-d global symptom score of 0 \[none\] or 1 \[mild\]; or a daily IBS-d global symptom score improved by ≥2.0 compared to the baseline average) for at least 50% of days with diary entries during each interval. IBS-d Global Symptom Scale was a 5 point scale, score ranging from 0 to 4. 0= no symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms and 4 = very severe symptoms. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=427 Participants
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=426 Participants
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 Participants
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Responders during Weeks 1-12
|
35.1 percentage of participants
|
34.7 percentage of participants
|
28.8 percentage of participants
|
|
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Responders during Weeks 1-26
|
36.3 percentage of participants
|
37.1 percentage of participants
|
32.3 percentage of participants
|
|
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Responders during Weeks 1-4
|
32.6 percentage of participants
|
31.9 percentage of participants
|
26.9 percentage of participants
|
|
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Responders during Weeks 5-8
|
37.0 percentage of participants
|
38.7 percentage of participants
|
32.8 percentage of participants
|
|
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Responders during Weeks 9-12
|
35.6 percentage of participants
|
36.6 percentage of participants
|
34.0 percentage of participants
|
|
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Responders during Weeks 13-16
|
35.8 percentage of participants
|
35.9 percentage of participants
|
35.4 percentage of participants
|
|
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Responders during Weeks 17-20
|
37.5 percentage of participants
|
36.4 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Responders during Weeks 21-24
|
36.8 percentage of participants
|
35.2 percentage of participants
|
29.5 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (End of Treatment [EOT])Population: ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
IBS-QoL responders were defined as participants who achieved at least a 14-point improvement in IBS-QoL total score from baseline to the applicable visit. The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100-point (0= worst; 100=better) scale for ease of interpretation.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=427 Participants
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=426 Participants
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 Participants
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
Responders at Week 4
|
42.6 percentage of participants
|
44.1 percentage of participants
|
37.0 percentage of participants
|
|
Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
Responders at Week 8
|
43.8 percentage of participants
|
49.8 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
Responders at Week 12
|
44.3 percentage of participants
|
48.1 percentage of participants
|
44.0 percentage of participants
|
|
Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
Responders at Week 18
|
44.5 percentage of participants
|
45.1 percentage of participants
|
43.3 percentage of participants
|
|
Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
Responders at Week 26
|
45.4 percentage of participants
|
45.1 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
Responders at Week 36
|
41.0 percentage of participants
|
43.2 percentage of participants
|
39.6 percentage of participants
|
|
Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
Responders at Week 44
|
39.6 percentage of participants
|
40.1 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
Responders at Week 52/EOT
|
49.4 percentage of participants
|
54.9 percentage of participants
|
47.8 percentage of participants
|
SECONDARY outcome
Timeframe: 12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26)Population: ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.
Adequate relief of IBS symptoms was assessed once weekly by participants answering the IBS-AR item in the electronic diary. IBS-AR responders were defined as participants with a weekly response of "Yes" to adequate relief of their IBS symptoms for at least 50% of the total weeks during the interval. A participant must have had a positive response on ≥6 weeks for the 12-week interval and ≥13 weeks for the 26-week interval, regardless of diary compliance, to be a responder.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=427 Participants
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=426 Participants
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 Participants
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale
Responders during Weeks 1-12
|
52.9 percentage of participants
|
54.2 percentage of participants
|
43.8 percentage of participants
|
|
Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale
Responders during Weeks 1-26
|
45.7 percentage of participants
|
49.5 percentage of participants
|
40.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12 and 26Population: Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.
Symptoms of abdominal discomfort were recorded on a 0 to 10 scale, where 0 corresponded to no discomfort and 10 corresponded to worst imaginable discomfort. A negative change from Baseline indicates the discomfort decreased.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=427 Participants
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=426 Participants
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 Participants
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Change From Baseline in Daily Abdominal Discomfort Scores
Change at Week 4
|
-2.24 score on a scale
Standard Deviation 2.204
|
-2.41 score on a scale
Standard Deviation 2.326
|
-2.01 score on a scale
Standard Deviation 2.156
|
|
Change From Baseline in Daily Abdominal Discomfort Scores
Change at Week 12
|
-2.75 score on a scale
Standard Deviation 2.534
|
-2.97 score on a scale
Standard Deviation 2.526
|
-2.61 score on a scale
Standard Deviation 2.444
|
|
Change From Baseline in Daily Abdominal Discomfort Scores
Change at Week 26
|
-3.27 score on a scale
Standard Deviation 2.578
|
-3.52 score on a scale
Standard Deviation 2.543
|
-3.00 score on a scale
Standard Deviation 2.579
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12 and 26Population: Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.
Symptoms of abdominal bloating were recorded on a 0 to 10 scale, where 0 corresponded to no bloating and 10 corresponded to worst imaginable bloating. A negative change from Baseline indicates the bloating decreased.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=427 Participants
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=426 Participants
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 Participants
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Change From Baseline in Daily Abdominal Bloating Scores
Change at Week 4
|
-1.84 score on a scale
Standard Deviation 2.303
|
-2.03 score on a scale
Standard Deviation 2.333
|
-1.72 score on a scale
Standard Deviation 2.303
|
|
Change From Baseline in Daily Abdominal Bloating Scores
Change at Week 12
|
-2.42 score on a scale
Standard Deviation 2.616
|
-2.49 score on a scale
Standard Deviation 2.533
|
-2.16 score on a scale
Standard Deviation 2.544
|
|
Change From Baseline in Daily Abdominal Bloating Scores
Change at Week 26
|
-2.76 score on a scale
Standard Deviation 2.823
|
-2.94 score on a scale
Standard Deviation 2.576
|
-2.47 score on a scale
Standard Deviation 2.562
|
SECONDARY outcome
Timeframe: Weeks 4, 12 and 26Population: Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.
Participants recorded the number of bowel movements over 24 hours daily throughout the treatment.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=427 Participants
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=426 Participants
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 Participants
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Number of Bowel Movements Per Day
Week 4
|
3.20 bowel movements per day
Standard Deviation 2.090
|
3.20 bowel movements per day
Standard Deviation 2.236
|
3.72 bowel movements per day
Standard Deviation 2.100
|
|
Number of Bowel Movements Per Day
Week 12
|
3.12 bowel movements per day
Standard Deviation 2.143
|
3.09 bowel movements per day
Standard Deviation 2.318
|
3.44 bowel movements per day
Standard Deviation 1.987
|
|
Number of Bowel Movements Per Day
Week 26
|
2.83 bowel movements per day
Standard Deviation 2.158
|
2.79 bowel movements per day
Standard Deviation 2.270
|
3.12 bowel movements per day
Standard Deviation 1.831
|
SECONDARY outcome
Timeframe: Weeks 4, 12 and 26Population: Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.
Participants recorded the number of incontinence episodes over 24 hours daily throughout the treatment.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=427 Participants
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=426 Participants
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 Participants
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Number of Bowel Incontinence Episodes
Week 4
|
0.74 incontinence episodes
Standard Deviation 1.603
|
0.72 incontinence episodes
Standard Deviation 1.534
|
0.93 incontinence episodes
Standard Deviation 2.140
|
|
Number of Bowel Incontinence Episodes
Week 12
|
0.63 incontinence episodes
Standard Deviation 1.542
|
0.71 incontinence episodes
Standard Deviation 1.663
|
0.94 incontinence episodes
Standard Deviation 3.612
|
|
Number of Bowel Incontinence Episodes
Week 26
|
0.46 incontinence episodes
Standard Deviation 1.298
|
0.58 incontinence episodes
Standard Deviation 1.358
|
0.69 incontinence episodes
Standard Deviation 1.500
|
SECONDARY outcome
Timeframe: Weeks 4, 12 and 26Population: Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.
An incontinence free day was one where the participant reports zero incontinence episodes. The number of incontinence free days for a participant was assessed each week based on the number of reported days.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=427 Participants
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=426 Participants
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 Participants
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Number of Bowel Incontinence Free Days
Week 4
|
4.83 days
Standard Deviation 2.745
|
4.95 days
Standard Deviation 2.618
|
4.63 days
Standard Deviation 2.741
|
|
Number of Bowel Incontinence Free Days
Week 12
|
4.96 days
Standard Deviation 2.672
|
4.79 days
Standard Deviation 2.671
|
4.64 days
Standard Deviation 2.704
|
|
Number of Bowel Incontinence Free Days
Week 26
|
4.39 days
Standard Deviation 2.465
|
4.35 days
Standard Deviation 2.449
|
4.00 days
Standard Deviation 2.539
|
SECONDARY outcome
Timeframe: Weeks 4, 12 and 26Population: Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.
Participants recorded the number of urgency episodes over 24 hours daily throughout the treatment.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=427 Participants
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=426 Participants
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 Participants
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Number of Urgency Episodes Per Day
Week 4
|
1.75 episodes per day
Standard Deviation 1.840
|
1.74 episodes per day
Standard Deviation 1.879
|
2.19 episodes per day
Standard Deviation 2.082
|
|
Number of Urgency Episodes Per Day
Week 12
|
1.55 episodes per day
Standard Deviation 1.777
|
1.60 episodes per day
Standard Deviation 1.995
|
1.81 episodes per day
Standard Deviation 1.883
|
|
Number of Urgency Episodes Per Day
Week 26
|
1.25 episodes per day
Standard Deviation 1.773
|
1.45 episodes per day
Standard Deviation 2.113
|
1.55 episodes per day
Standard Deviation 1.853
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (EOT)Population: Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.
The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=427 Participants
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=426 Participants
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 Participants
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
IBS-QoL Total Scores
Responders at Week 4
|
62.37 score on a scale
Standard Deviation 23.747
|
64.34 score on a scale
Standard Deviation 24.049
|
57.13 score on a scale
Standard Deviation 24.318
|
|
IBS-QoL Total Scores
Responders at Week 8
|
66.22 score on a scale
Standard Deviation 23.919
|
67.73 score on a scale
Standard Deviation 23.421
|
59.46 score on a scale
Standard Deviation 24.323
|
|
IBS-QoL Total Scores
Responders at Week 12
|
66.80 score on a scale
Standard Deviation 24.131
|
68.93 score on a scale
Standard Deviation 23.938
|
61.72 score on a scale
Standard Deviation 25.545
|
|
IBS-QoL Total Scores
Responders at Week 18
|
68.75 score on a scale
Standard Deviation 23.902
|
70.05 score on a scale
Standard Deviation 23.662
|
63.60 score on a scale
Standard Deviation 24.618
|
|
IBS-QoL Total Scores
Responders at Week 26
|
70.74 score on a scale
Standard Deviation 23.312
|
71.34 score on a scale
Standard Deviation 23.106
|
64.83 score on a scale
Standard Deviation 24.380
|
|
IBS-QoL Total Scores
Responders at Week 36
|
70.53 score on a scale
Standard Deviation 23.043
|
72.37 score on a scale
Standard Deviation 23.246
|
66.47 score on a scale
Standard Deviation 24.034
|
|
IBS-QoL Total Scores
Responders at Week 44
|
70.30 score on a scale
Standard Deviation 24.408
|
72.15 score on a scale
Standard Deviation 24.398
|
65.59 score on a scale
Standard Deviation 25.045
|
|
IBS-QoL Total Scores
Responders at Week 52/EOT
|
68.85 score on a scale
Standard Deviation 24.754
|
71.02 score on a scale
Standard Deviation 24.294
|
63.93 score on a scale
Standard Deviation 26.359
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 18, 26, 36, 44, and 52/EOTPopulation: Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.
The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation. A positive change from Baseline indicates that quality of life improved.
Outcome measures
| Measure |
Eluxadoline 75 mg
n=427 Participants
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=426 Participants
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 Participants
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Change From Baseline in IBS-QoL Total Scores
Change at Week 4
|
16.49 score on a scale
Standard Deviation 20.693
|
17.86 score on a scale
Standard Deviation 20.191
|
13.25 score on a scale
Standard Deviation 18.475
|
|
Change From Baseline in IBS-QoL Total Scores
Change at Week 8
|
19.88 score on a scale
Standard Deviation 21.855
|
21.08 score on a scale
Standard Deviation 21.347
|
15.76 score on a scale
Standard Deviation 19.398
|
|
Change From Baseline in IBS-QoL Total Scores
Change at Week 12
|
20.26 score on a scale
Standard Deviation 23.412
|
22.76 score on a scale
Standard Deviation 22.592
|
17.76 score on a scale
Standard Deviation 21.523
|
|
Change From Baseline in IBS-QoL Total Scores
Change at Week 18
|
23.09 score on a scale
Standard Deviation 23.846
|
24.18 score on a scale
Standard Deviation 23.025
|
19.80 score on a scale
Standard Deviation 22.368
|
|
Change From Baseline in IBS-QoL Total Scores
Change at Week 26
|
25.28 score on a scale
Standard Deviation 23.679
|
25.80 score on a scale
Standard Deviation 23.998
|
20.62 score on a scale
Standard Deviation 22.306
|
|
Change From Baseline in IBS-QoL Total Scores
Change at Week 36
|
25.37 score on a scale
Standard Deviation 24.603
|
27.18 score on a scale
Standard Deviation 24.201
|
22.64 score on a scale
Standard Deviation 23.414
|
|
Change From Baseline in IBS-QoL Total Scores
Change at Week 44
|
25.13 score on a scale
Standard Deviation 24.948
|
26.64 score on a scale
Standard Deviation 25.017
|
21.77 score on a scale
Standard Deviation 23.977
|
|
Change From Baseline in IBS-QoL Total Scores
Change at Week 52/EOT
|
23.30 score on a scale
Standard Deviation 23.959
|
25.86 score on a scale
Standard Deviation 23.854
|
20.66 score on a scale
Standard Deviation 23.956
|
Adverse Events
Eluxadoline 75 mg
Serious events: 25 serious events
Other events: 84 other events
Deaths: 0 deaths
Eluxadoline 100 mg
Serious events: 27 serious events
Other events: 89 other events
Deaths: 0 deaths
Placebo
Serious events: 16 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eluxadoline 75 mg
n=428 participants at risk
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=479 participants at risk
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 participants at risk
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Infections and infestations
Necrotising fasciitis
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.63%
3/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Gastrointestinal disorders
Diverticulum intestinal hemorrhagic
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.42%
2/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Infections and infestations
Bronchitis
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Infections and infestations
Diverticulitis
|
0.47%
2/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Infections and infestations
Influenza
|
0.47%
2/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Cardiac disorders
Angina pectoris
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.42%
2/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Cardiac disorders
Myocardial infarction
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Nervous system disorders
Presyncope
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Nervous system disorders
Primary progressive multiple sclerosis
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Nervous system disorders
Syncope
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Nervous system disorders
Syncope vasovagal
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Vascular disorders
Hematoma
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Vascular disorders
Hypertension
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Vascular disorders
Hypertensive crisis
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.42%
2/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.47%
2/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.42%
2/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Psychiatric disorders
Conversion disorder
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Eye disorders
Papilloedema
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
General disorders
Chest pain
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.23%
1/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.21%
1/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneousa
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Psychiatric disorders
Depression
|
0.23%
1/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
0.00%
0/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
Other adverse events
| Measure |
Eluxadoline 75 mg
n=428 participants at risk
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
|
Eluxadoline 100 mg
n=479 participants at risk
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
|
Placebo
n=427 participants at risk
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
6.3%
27/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
9.2%
44/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
2.8%
12/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Gastrointestinal disorders
Nausea
|
7.9%
34/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
6.5%
31/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
4.4%
19/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
22/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
4.0%
19/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
1.6%
7/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
14/428 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
5.2%
25/479 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
3.5%
15/427 • Up to 54 weeks
The Safety Analysis Set included enrolled participants who received at least one dose of study drug and presents data according to the actual treatment received. A total of 53 participants were randomized to the Eluxadoline 75 mg arm but received Eluxadoline 100 mg due to site misallocations, these participants were included in Eluxadoline 100 mg arm. Therefore, the number of participants in the Eluxadoline 100 mg arm were more than the number of participants who were randomized to this arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor will work with the Investigators to determine how any manuscript or publication in a scientific journal is written and edited, the number and order of authors, the publication to which it will be submitted, and other related issues. The sponsor has final approval authority over all such issues. Data are the property of the sponsor and cannot be published without prior authorization from the sponsor, but data and publication thereof will not be unduly withheld.
- Publication restrictions are in place
Restriction type: OTHER