Trial Outcomes & Findings for One Year Study of Rifaximin Delayed Release (DR) in Crohn's Disease (NCT NCT02240108)
NCT ID: NCT02240108
Last Updated: 2019-09-10
Results Overview
Clinical symptom remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 16 visit being less than or equal to (≤) 10 (from CDAI Item 1). CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
81 participants
Primary outcome timeframe
Week 16
Results posted on
2019-09-10
Participant Flow
A total of 81 participants were enrolled and randomized in this study.
Participants were randomized in a 1:1 allocation to Rifaximin EIR 800 mg or Placebo at the beginning of the treatment period and were maintained on that treatment assignment for 16 weeks, followed by an open-label long-term active treatment extension of an additional 36 weeks.
Participant milestones
| Measure |
Rifaximin EIR 800 mg
Participants received rifaximin extended intestinal release (EIR) 400 milligrams (mg) tablets orally twice daily for 52 weeks.
|
Placebo
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
46
|
|
Overall Study
Intent-to-treat (ITT) Population
|
35
|
45
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
14
|
25
|
Reasons for withdrawal
| Measure |
Rifaximin EIR 800 mg
Participants received rifaximin extended intestinal release (EIR) 400 milligrams (mg) tablets orally twice daily for 52 weeks.
|
Placebo
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Overall Study
Other than specified
|
8
|
6
|
|
Overall Study
Adverse Event
|
1
|
9
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
9
|
|
Overall Study
StudyTerminated by Sponsor
|
0
|
1
|
Baseline Characteristics
One Year Study of Rifaximin Delayed Release (DR) in Crohn's Disease
Baseline characteristics by cohort
| Measure |
Rifaximin EIR 800 mg
n=35 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=45 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 14.85 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 12.97 • n=7 Participants
|
43.3 years
STANDARD_DEVIATION 13.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Crohn's Disease Activity Index (CDAI) Score
|
305.4 units on a scale
STANDARD_DEVIATION 69.51 • n=5 Participants
|
300.0 units on a scale
STANDARD_DEVIATION 56.39 • n=7 Participants
|
302.4 units on a scale
STANDARD_DEVIATION 62.11 • n=5 Participants
|
|
Simple Endoscopic Score for Crohn's Disease (SES-CD)
|
12.0 units on a scale
STANDARD_DEVIATION 5.01 • n=5 Participants
|
11.7 units on a scale
STANDARD_DEVIATION 4.61 • n=7 Participants
|
11.8 units on a scale
STANDARD_DEVIATION 4.76 • n=5 Participants
|
|
Duration of Disease
|
10.5 years
STANDARD_DEVIATION 8.57 • n=5 Participants
|
9.6 years
STANDARD_DEVIATION 9.53 • n=7 Participants
|
10.0 years
STANDARD_DEVIATION 9.08 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: ITT population included all randomized participants who received at least 1 dose of study drug.
Clinical symptom remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 16 visit being less than or equal to (≤) 10 (from CDAI Item 1). CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=35 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=45 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1) at Week 16
|
6 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: ITT population included all randomized participants who received at least 1 dose of study drug.
Clinical Symptom Remission defined by (2) an abdominal pain (graded from 0 \[less severe\]-3 \[more severe\]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 16 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=35 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=45 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 2) at Week 16
|
19 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: ITT population included all randomized participants who received at least 1 dose of study drug.
Clinical Symptom Remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 16 visit being ≤ 10 (from CDAI Item 1); and (2) an abdominal pain (graded from 0 \[less severe\]-3 \[more severe\]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 16 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=35 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=45 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) at Week 16
|
5 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16 to 17Population: ITT population included all randomized participants who received at least 1 dose of study drug.
Endoscopic response defined as a ≥ 3-point decrease in the SES-CD from baseline to the SES-CD score obtained between Week 16 and Week 17. SES-CD scores were calculated from centrally-read digital video of ileocolonoscopies performed at baseline and between Week 16 and Week 17. SES-CD is a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=35 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=45 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants With Endoscopic Response Between Week 16 and 17
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: ITT population included all randomized participants who received at least 1 dose of study drug.
Clinical symptom remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 52 visit being ≤ 10 (from CDAI Item 1). CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=35 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=45 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1) at Week 52
|
7 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: ITT population included all randomized participants who received at least 1 dose of study drug.
Clinical Symptom Remission defined by (2) an abdominal pain (graded from 0 \[less severe\]-3 \[more severe\]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 52 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=35 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=45 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 2) at Week 52
|
9 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: ITT population included all randomized participants who received at least 1 dose of study drug.
Clinical Symptom Remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 52 visit being ≤ 10 (from CDAI Item 1); and (2) an abdominal pain (graded from 0 \[less severe\]-3 \[more severe\]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 52 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=35 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=45 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) at Week 52
|
6 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: ITT population included all randomized participants who received at least 1 dose of study drug.
Endoscopic response defined as a ≥ 3-point decrease in the SES-CD from baseline to the SES-CD score obtained at Week 52. SES-CD is a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=35 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=45 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants With Endoscopic Response at Week 52
|
9 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population included all randomized participants who received at least 1 dose of study drug.
Clinical remission was defined as a CDAI score of less than 150 points at Week 16. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=35 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=45 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Remission (Defined as CDAI Score of <150) at Week 16
|
17 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 52Population: ITT population included all randomized participants who received at least 1 dose of study drug.
Clinical Symptom Remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to each clinical visit being ≤ 10 (from CDAI Item 1); and (2) an abdominal pain (graded from 0 \[less severe\]-3 \[more severe\]) rating of ≤ 1 (from CDAI Item 2) on each day for the last 7 days prior to each clinic visit in ≥ 80% of the study visits during the 52-week treatment period, including Week 52. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=35 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=45 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) Over Time
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 52Population: ITT population included all randomized participants who received at least 1 dose of study drug.
SES-CD is a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Rifaximin EIR 800 mg
n=35 Participants
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=45 Participants
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Number of Participants With SES-CD Score of 0 at Week 52
|
0 Participants
|
3 Participants
|
Adverse Events
Rifaximin EIR 800 mg
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 9 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rifaximin EIR 800 mg
n=35 participants at risk
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=45 participants at risk
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
1/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
0.00%
0/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Cardiac disorders
Coronary artery disease
|
2.9%
1/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
0.00%
0/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Cardiac disorders
Myocardial infarction
|
2.9%
1/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
0.00%
0/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
2.2%
1/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
2.2%
1/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
2.2%
1/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
6.7%
3/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
2.2%
1/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
2.2%
1/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
2.2%
1/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
2.2%
1/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
2.2%
1/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
2.2%
1/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
4.4%
2/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
General disorders
Fatigue
|
2.9%
1/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
0.00%
0/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
2.2%
1/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Injury, poisoning and procedural complications
Overdose
|
2.9%
1/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
0.00%
0/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
2.2%
1/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
2.2%
1/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
2.2%
1/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
2.9%
1/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
0.00%
0/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Nervous system disorders
Seizure
|
2.9%
1/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
0.00%
0/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
2.9%
1/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
0.00%
0/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
2.2%
1/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
2.2%
1/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
Other adverse events
| Measure |
Rifaximin EIR 800 mg
n=35 participants at risk
Participants received rifaximin EIR 400 mg tablets orally twice daily for 52 weeks.
|
Placebo
n=45 participants at risk
Participants received placebo matched to rifaximin EIR tablets orally twice daily for 52 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.6%
3/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
2.2%
1/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.7%
2/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
0.00%
0/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
2/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
15.6%
7/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.4%
4/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
4.4%
2/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Crohn's disease
|
8.6%
3/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
15.6%
7/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.4%
4/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
11.1%
5/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Nausea
|
8.6%
3/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
8.9%
4/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
8.9%
4/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Gastrointestinal disorders
Vomiting
|
11.4%
4/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
8.9%
4/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
General disorders
Fatigue
|
5.7%
2/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
4.4%
2/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
General disorders
Pain
|
5.7%
2/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
0.00%
0/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
General disorders
Pyrexia
|
5.7%
2/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
4.4%
2/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Infections and infestations
Gastroenteritis viral
|
5.7%
2/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
0.00%
0/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Infections and infestations
Nasopharyngitis
|
11.4%
4/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
2.2%
1/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.7%
2/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
0.00%
0/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Infections and infestations
Sinusitis
|
5.7%
2/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
0.00%
0/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
2/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
4.4%
2/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
6.7%
3/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.7%
2/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
0.00%
0/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.9%
1/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
6.7%
3/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
5.7%
2/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
0.00%
0/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.6%
3/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
6.7%
3/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.6%
3/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
4.4%
2/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
2/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
0.00%
0/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Nervous system disorders
Headache
|
8.6%
3/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
11.1%
5/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.7%
2/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
0.00%
0/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
2/35 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
8.9%
4/45 • Adverse events (AEs) were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment [Week 54]) .
Occurrences of AEs or serious adverse events (SAEs) were reported during each study visit or by the participant outside of scheduled visits.
|
Additional Information
Director of Clinical Operations
Bausch Health Americas, Inc.
Phone: 908-927-0873
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
- Publication restrictions are in place
Restriction type: OTHER