Trial Outcomes & Findings for A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (NCT NCT00269399)
NCT ID: NCT00269399
Last Updated: 2019-10-14
Results Overview
Resolution or improvement of baseline signs and symptoms was assessed as * Absence of severe abdominal pain for 2 consecutive days at the test of cure (TOC) Visit (Day 14 +/-1); * Absence of fever (\< 38°C/100.4°F) for 2 consecutive days at the TOC Visit; and * 3 unformed (loose or watery) stools per day for at least 48 hours that was sustained through the TOC Visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
237 participants
Primary outcome timeframe
14 days
Results posted on
2019-10-14
Participant Flow
Participant milestones
| Measure |
Rifaximin Treatment Arm
rifaximin 400mg taken 3 times a day
Rifaximin (Xifaxan)
|
Vancomycin Comparator Arm
vancomycin 125mg taken 4 times a day
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
118
|
|
Overall Study
COMPLETED
|
78
|
91
|
|
Overall Study
NOT COMPLETED
|
41
|
27
|
Reasons for withdrawal
| Measure |
Rifaximin Treatment Arm
rifaximin 400mg taken 3 times a day
Rifaximin (Xifaxan)
|
Vancomycin Comparator Arm
vancomycin 125mg taken 4 times a day
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
27
|
10
|
|
Overall Study
Adverse Event
|
10
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
|
Overall Study
Negative Lab Result for C. difficile
|
2
|
3
|
|
Overall Study
Other
|
0
|
4
|
|
Overall Study
Development of exclusion criteria
|
0
|
1
|
Baseline Characteristics
A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
Baseline characteristics by cohort
| Measure |
Rifaximin Treatment Arm
n=117 Participants
rifaximin 400mg taken 3 times a day
Rifaximin (Xifaxan)
|
Vancomycin Comparator Arm
n=115 Participants
vancomycin 125mg taken 4 times a day
Vancomycing
|
Total
n=232 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 16.22 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION 18.08 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 17.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
103 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Modified Intent-to-Treat (MITT) population included all randomized subjects who had acute diarrhea and with a positive C. difficile stool toxin assay within ± 48 hours of screening and received at least one dose of study drug.
Resolution or improvement of baseline signs and symptoms was assessed as * Absence of severe abdominal pain for 2 consecutive days at the test of cure (TOC) Visit (Day 14 +/-1); * Absence of fever (\< 38°C/100.4°F) for 2 consecutive days at the TOC Visit; and * 3 unformed (loose or watery) stools per day for at least 48 hours that was sustained through the TOC Visit.
Outcome measures
| Measure |
Rifaximin Treatment Arm
n=117 Participants
rifaximin 400mg taken 3 times a day
Rifaximin (Xifaxan)
|
Vancomycin Comparator Arm
n=115 Participants
vancomycin 125mg taken 4 times a day
Vancomycin
|
|---|---|---|
|
Proportion of Participants Achieving Clinical Success, Where Clinical Success is Defined as Resolution or Improvement of Baseline Signs and Symptoms i.e., Abdominal Pain, Fever, Diarrhea.
|
67 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: 42 daysPopulation: Participants included in this analysis were restricted to those who experienced initial clinical success at the TOC Visit following the 10-day Treatment Phase.
Recurrence of CDAD was defined as diarrhea and a positive Clostridium difficile stool toxin assay that occurs after initial clinical success.
Outcome measures
| Measure |
Rifaximin Treatment Arm
n=67 Participants
rifaximin 400mg taken 3 times a day
Rifaximin (Xifaxan)
|
Vancomycin Comparator Arm
n=73 Participants
vancomycin 125mg taken 4 times a day
Vancomycin
|
|---|---|---|
|
Proportion of Participants Recurrence-free of Clostridium Difficile-associated Diarrhea (CDAD), After Achieving Clinical Success
|
61 Participants
|
63 Participants
|
Adverse Events
Rifaximin Treatment Arm
Serious events: 28 serious events
Other events: 6 other events
Deaths: 0 deaths
Vancomycin Comparator Arm
Serious events: 14 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rifaximin Treatment Arm
n=120 participants at risk
rifaximin 400mg taken 3 times a day
Rifaximin (Xifaxan)
|
Vancomycin Comparator Arm
n=116 participants at risk
vancomycin 125mg taken 4 times a day
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
4/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Gastrointestinal disorders
Diarrhea
|
2.5%
3/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
2.6%
3/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
General disorders
Pyrexia
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Infections and infestations
Clostridial infection
|
1.7%
2/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Infections and infestations
Clostridium colitis
|
1.7%
2/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
1.7%
2/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
3/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
3.4%
4/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
1.7%
2/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Renal and urinary disorders
Renal failure acute
|
2.5%
3/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
1.7%
2/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Vascular disorders
Hypotension
|
2.5%
3/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
1.7%
2/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Blood and lymphatic system disorders
Anemia hemolytic autoimmune
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
General disorders
Chest pain
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Infections and infestations
Bacteremia
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Infections and infestations
Cellulitis
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Infections and infestations
Klebsiella sepsis
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Infections and infestations
Pseudomonas infection
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Infections and infestations
Sepsis
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Infections and infestations
Urinary tract infection
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Infections and infestations
Wound infection
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Investigations
Blood creatinine increased
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Investigations
Blood urea increased
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung meoplasm malignant
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Nervous system disorders
Aphasia
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Psychiatric disorders
Suicide attempt
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Respiratory, thoracic and mediastinal disorders
Chromic obstructive pulmonary disease
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.83%
1/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.00%
0/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
|
Respiratory, thoracic and mediastinal disorders
Hydopneumothorax
|
0.00%
0/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
0.86%
1/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
Other adverse events
| Measure |
Rifaximin Treatment Arm
n=120 participants at risk
rifaximin 400mg taken 3 times a day
Rifaximin (Xifaxan)
|
Vancomycin Comparator Arm
n=116 participants at risk
vancomycin 125mg taken 4 times a day
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
5.0%
6/120 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
1.7%
2/116 • 42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
|
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 for details.
- Publication restrictions are in place
Restriction type: OTHER