Trial Outcomes & Findings for Optimal Treatment for Recurrent Clostridium Difficile (NCT NCT02667418)
NCT ID: NCT02667418
Last Updated: 2025-11-12
Results Overview
The Primary outcome will be sustained clinical response as measured at study day 59 for all treatment regimens. Sustained clinical response is a composite outcome that includes symptom resolution during treatment without any of the following (as assessed on day 59): 1. Diarrhea recurrence 2. Other non-fatal clinical events including severe abdominal pain, toxic megacolon (where diarrhea ceases but is not a beneficial outcome), and colectomy 3. Death
TERMINATED
PHASE4
308 participants
Day 59 for all treatment regimens.
2025-11-12
Participant Flow
Participant milestones
| Measure |
Fidaxomicin
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
Vancomycin T/P
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Vancomycin
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
105
|
102
|
101
|
|
Overall Study
Modified Intent-To-Treat
|
100
|
99
|
100
|
|
Overall Study
Safety Set
|
102
|
100
|
100
|
|
Overall Study
COMPLETED
|
84
|
91
|
94
|
|
Overall Study
NOT COMPLETED
|
21
|
11
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant in Fidaxomicin with missing race information
Baseline characteristics by cohort
| Measure |
Fidaxomicin
n=105 Participants
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
Vancomycin T/P
n=102 Participants
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Vancomycin
n=101 Participants
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 12.5 • n=105 Participants
|
67.7 years
STANDARD_DEVIATION 11.9 • n=102 Participants
|
67.9 years
STANDARD_DEVIATION 12.0 • n=101 Participants
|
67.4 years
STANDARD_DEVIATION 12.1 • n=308 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=105 Participants
|
6 Participants
n=102 Participants
|
11 Participants
n=101 Participants
|
29 Participants
n=308 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=105 Participants
|
96 Participants
n=102 Participants
|
90 Participants
n=101 Participants
|
279 Participants
n=308 Participants
|
|
Race/Ethnicity, Customized
White
|
86 Participants
n=104 Participants • One participant in Fidaxomicin with missing race information
|
80 Participants
n=102 Participants • One participant in Fidaxomicin with missing race information
|
79 Participants
n=101 Participants • One participant in Fidaxomicin with missing race information
|
245 Participants
n=307 Participants • One participant in Fidaxomicin with missing race information
|
|
Race/Ethnicity, Customized
African American
|
15 Participants
n=104 Participants • One participant in Fidaxomicin with missing race information
|
18 Participants
n=102 Participants • One participant in Fidaxomicin with missing race information
|
19 Participants
n=101 Participants • One participant in Fidaxomicin with missing race information
|
52 Participants
n=307 Participants • One participant in Fidaxomicin with missing race information
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=104 Participants • One participant in Fidaxomicin with missing race information
|
4 Participants
n=102 Participants • One participant in Fidaxomicin with missing race information
|
3 Participants
n=101 Participants • One participant in Fidaxomicin with missing race information
|
10 Participants
n=307 Participants • One participant in Fidaxomicin with missing race information
|
PRIMARY outcome
Timeframe: Day 59 for all treatment regimens.Population: mITT Primary Analysis: Missing primary outcome D-COM at Day 59 in the mITT analysis was imputed by an imputation model. mITT Sensitivity Analysis 1: Missing primary outcome D-COM at Day 59 was treated as failure. mITT Sensitivity Analysis 2: Missing outcomes were excluded as a complete case analysis. PP analysis: Participants who 1) failed to respond by day 10 or completed day 59 follow-up and (2) took 80% of their assigned drug according to the pill count (Per-Protocol population).
The Primary outcome will be sustained clinical response as measured at study day 59 for all treatment regimens. Sustained clinical response is a composite outcome that includes symptom resolution during treatment without any of the following (as assessed on day 59): 1. Diarrhea recurrence 2. Other non-fatal clinical events including severe abdominal pain, toxic megacolon (where diarrhea ceases but is not a beneficial outcome), and colectomy 3. Death
Outcome measures
| Measure |
Vancomycin
n=100 Participants
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
Vancomycin T/P
n=100 Participants
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Fidaxomicin
n=99 Participants
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
|---|---|---|---|
|
Number of Participants With Sustained Clinical Response as Measured at Study Day 59 for All Treatment Regimens
mITT Sensitivity Analysis 1
|
42 Participants
|
40 Participants
|
56 Participants
|
|
Number of Participants With Sustained Clinical Response as Measured at Study Day 59 for All Treatment Regimens
PP Analysis
|
42 Participants
|
39 Participants
|
55 Participants
|
|
Number of Participants With Sustained Clinical Response as Measured at Study Day 59 for All Treatment Regimens
mITT Primary Analysis
|
44 Participants
|
44 Participants
|
58 Participants
|
|
Number of Participants With Sustained Clinical Response as Measured at Study Day 59 for All Treatment Regimens
mITT Sensitivity Analysis 2
|
42 Participants
|
40 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: 28 Days Post End of TherapyPopulation: mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different.
Sustained Diarrhea Composite Outcome (D-COM) at 28 days Post End of Therapy- Secondary Analyses of Primary Outcome. Sustained clinical response without recurrent CDI (CDI-COM) at 28 days post end of therapy for all three treatment regimens. Sustained clinical response was defined using the same criteria as previously stated except that the endpoint will be 28 days after the last dose of treatment drug for each treatment arm (day 38 for vancomycin and fidaxomicin, and day 59 for vancomycin taper/pulse).Sustained clinical response is a composite endpoint defined as symptom resolution during treatment without diarrhea recurrence, mortality or other important clinical outcomes at any time during the follow-up period. Those participants failing to meet the criteria of symptom resolution (diarrhea resolution) by the end of the active treatment (day 10 for all groups), or who experience a recurrence during the follow-up period, will be considered study treatment failures.
Outcome measures
| Measure |
Vancomycin
n=96 Participants
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
Vancomycin T/P
n=95 Participants
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Fidaxomicin
n=92 Participants
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
|---|---|---|---|
|
Sustained Diarrhea Composite Outcome (D-COM) at 28 Days Post End of Therapy
|
48 Participants
|
56 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Day 59 post randomizationPopulation: mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different.
Clostridium difficile Infection Composite Outcome (CDI-COM) at day 59 post randomization. Sustained response in CDI-COM is defined using the same composite endpoint criteria as was used in the D-COM composite outcome but with confirmation of no CDI recurrence by a negative C. difficile stool assay test (i.e., proportion of subjects who achieve symptom resolution by day 10 without recurrent CDI, without non-fatal clinical events, and without death).
Outcome measures
| Measure |
Vancomycin
n=91 Participants
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
Vancomycin T/P
n=91 Participants
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Fidaxomicin
n=83 Participants
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
|---|---|---|---|
|
Clostridium Difficile Infection Composite Outcome (CDI-COM)
|
44 Participants
|
59 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Day 10 since randomizationPopulation: mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different.
The percentage of participants who had symptom resolution by Day 10 post randomization
Outcome measures
| Measure |
Vancomycin
n=98 Participants
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
Vancomycin T/P
n=97 Participants
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Fidaxomicin
n=96 Participants
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
|---|---|---|---|
|
Symptom Resolution
|
92 Participants
|
90 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: Day 90 since randomizationPopulation: mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different.
CDI recurrence following initial symptom resolution
Outcome measures
| Measure |
Vancomycin
n=78 Participants
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
Vancomycin T/P
n=79 Participants
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Fidaxomicin
n=68 Participants
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
|---|---|---|---|
|
CDI Recurrence
|
34 Participants
|
26 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Day 90 since randomizationPopulation: mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different.
Diarrhea recurrence with confirmation of recurrent CDI following initial symptom resolution
Outcome measures
| Measure |
Vancomycin
n=83 Participants
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
Vancomycin T/P
n=85 Participants
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Fidaxomicin
n=77 Participants
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
|---|---|---|---|
|
Diarrhea Recurrence
|
41 Participants
|
35 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Day 10 since randomizationPopulation: mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different.
Change in patient reported C.diff Health Related Quality of Life (HRQOL) from baseline (day 0) to day 10. The HRQOL is measured with patient self-reported 32-item questionnaire. The summary measure, CDiff32-QOL, is the total score that sums over 32 individual items with each item rated on a 5-point Likert scale and then transformed to a 100-point scale with higher score indicating better C.diff Health Related QOL in general. The full scale of the HRQOL: 1-5 on a 5-point Likert scale and 0-100 on the 100-point scale; the minimum: 0 on the 100-point scale and maximum value: 100 on the 100-point scale. The summary measure (32 items) range on the 100-point scale: 0-3200.
Outcome measures
| Measure |
Vancomycin
n=101 Participants
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
Vancomycin T/P
n=102 Participants
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Fidaxomicin
n=105 Participants
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
|---|---|---|---|
|
C.Diff Health Related Quality of Life (HRQOL)
|
543.8 units on a scale
Standard Deviation 535.7
|
451.8 units on a scale
Standard Deviation 582.0
|
446.6 units on a scale
Standard Deviation 419.1
|
SECONDARY outcome
Timeframe: day 0- day 59Population: mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different.
Change in patient reported C.diff Health Related Quality of Life (HRQOL) from baseline day 0 to day 59. The HRQOL is measured with patient self-reported 32-item questionnaire. The summary measure, CDiff32-QOL, is the total score that sums over 32 individual items with each item rated on a 5-point Likert scale and then transformed to a 100-point scale with higher score indicating better C.diff Health Related QOL in general. The full scale of the HRQOL: 1-5 on a 5-point Likert scale and 0-100 on the 100-point scale; the minimum: 0 on the 100-point scale and maximum value: 100 on the 100-point scale. The summary measure (32 items) range on the 100-point scale: 0-3200.
Outcome measures
| Measure |
Vancomycin
n=101 Participants
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
Vancomycin T/P
n=102 Participants
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Fidaxomicin
n=105 Participants
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
|---|---|---|---|
|
C.Diff Health Related Quality of Life (HRQOL)
|
919.8 units on a scale
Standard Deviation 654.3
|
902.7 units on a scale
Standard Deviation 682.6
|
818.5 units on a scale
Standard Deviation 743.0
|
SECONDARY outcome
Timeframe: Day 59 since randomizationPopulation: mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different.
Sustained clinical response (D-COM) at day 59 for subgroups (infection with the BI/NAP1/027 strain (yes) at study enrollment; etc.). The sliced analysis was used to break down the subgroup factors into different sub-levels and then to explore the differences between treatment group (VAN-TP and FDX) and VAN control group at each level.
Outcome measures
| Measure |
Vancomycin
n=9 Participants
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
Vancomycin T/P
n=18 Participants
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Fidaxomicin
n=9 Participants
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
|---|---|---|---|
|
Sustained Clinical Response (D-COM) BI/NAP1/027 Strain as "Yes"
|
2 Participants
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 38 since randomizationPopulation: mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different.
Diarrhea recurrence with confirmation of recurrent CDI following initial symptom resolution. Diarrhea recurrence and diarrhea recurrence with confirmation of recurrent CDI following initial symptom resolution. Diarrhea (\>3 loose or semi-formed stools over 24 hours) over 48 consecutive hours in participants who achieved initial symptom resolution will be recorded separately from sustained clinical response as will confirmed CDI recurrence.
Outcome measures
| Measure |
Vancomycin
n=85 Participants
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
Vancomycin T/P
n=86 Participants
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Fidaxomicin
n=80 Participants
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
|---|---|---|---|
|
Diarrhea Recurrence
|
37 Participants
|
19 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Day 59 since randomizationPopulation: mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different.
Diarrhea recurrence with confirmation of recurrent CDI following initial symptom resolution
Outcome measures
| Measure |
Vancomycin
n=83 Participants
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
Vancomycin T/P
n=85 Participants
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Fidaxomicin
n=78 Participants
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
|---|---|---|---|
|
Diarrhea Recurrence
|
41 Participants
|
29 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Day 38 since randomizationPopulation: mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different.
CDI recurrence following initial symptom resolution
Outcome measures
| Measure |
Vancomycin
n=80 Participants
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
Vancomycin T/P
n=82 Participants
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Fidaxomicin
n=75 Participants
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
|---|---|---|---|
|
CDI Recurrence
|
28 Participants
|
12 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Day 59 since randomizationPopulation: mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different.
CDI recurrence following initial symptom resolution
Outcome measures
| Measure |
Vancomycin
n=78 Participants
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
Vancomycin T/P
n=79 Participants
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Fidaxomicin
n=71 Participants
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
|---|---|---|---|
|
CDI Recurrence
|
34 Participants
|
21 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Day 59 since randomizationPopulation: mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different.
Sustained clinical response (D-COM) at day 59 for subgroups (infection with the BI/NAP1/027 strain (no) at study enrollment; etc.). The sliced analysis was used to break down the subgroup factors into different sub-levels and then to explore the differences between therapy group (VAN-TP and FDX) and VAN control group at each level.
Outcome measures
| Measure |
Vancomycin
n=66 Participants
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
Vancomycin T/P
n=55 Participants
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Fidaxomicin
n=50 Participants
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
|---|---|---|---|
|
Sustained Clinical Response (D-COM) With the BI/NAP1/027 Strain no
|
32 Participants
|
34 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 90 Days After RandomizationPopulation: mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different.
Sustained Diarrhea Composite Outcome (D-COM) at 90 days after Randomization - Secondary Analyses of Primary Outcome
Outcome measures
| Measure |
Vancomycin
n=95 Participants
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
Vancomycin T/P
n=95 Participants
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Fidaxomicin
n=91 Participants
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
|---|---|---|---|
|
Sustained Diarrhea Composite Outcome (D-COM) at 90 Days After Randomization
|
42 Participants
|
51 Participants
|
36 Participants
|
Adverse Events
Fidaxomicin
Vancomycin T/P
Vancomycin
Serious adverse events
| Measure |
Fidaxomicin
n=102 participants at risk
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
Vancomycin T/P
n=100 participants at risk
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Vancomycin
n=100 participants at risk
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Cardiac disorders
Cardiac failure
|
2.0%
2/102 • Number of events 2 • 8 years, 8 months
|
2.0%
2/100 • Number of events 3 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Cardiac disorders
Mycardinal infection
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Cardiac disorders
Cardiogenic shock
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 3 • 8 years, 8 months
|
|
Gastrointestinal disorders
Upper Gastrointestinal hemorrhage
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
General disorders
chest pain
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
General disorders
complication associated with device
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
General disorders
death
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
General disorders
Pyrexia
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
General disorders
Asthenia
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
General disorders
Physical deconditioning
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Infections and infestations
Clostridium difficile infection
|
4.9%
5/102 • Number of events 5 • 8 years, 8 months
|
6.0%
6/100 • Number of events 6 • 8 years, 8 months
|
3.0%
3/100 • Number of events 3 • 8 years, 8 months
|
|
Infections and infestations
Pneumonia
|
2.0%
2/102 • Number of events 2 • 8 years, 8 months
|
3.0%
3/100 • Number of events 3 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Infections and infestations
Urinary tract Infection
|
2.0%
2/102 • Number of events 2 • 8 years, 8 months
|
4.0%
4/100 • Number of events 4 • 8 years, 8 months
|
2.0%
2/100 • Number of events 2 • 8 years, 8 months
|
|
Infections and infestations
Urosepsis
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Infections and infestations
Bacteraemia
|
2.0%
2/102 • Number of events 2 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Infections and infestations
Cardiac valve vegetation
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
3.0%
3/100 • Number of events 3 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Infections and infestations
Septic shock
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Infections and infestations
Appendicitis
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Infections and infestations
COVID-19 pneumonia
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Infections and infestations
Clostridial sepsis
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
2.0%
2/100 • Number of events 2 • 8 years, 8 months
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Injury, poisoning and procedural complications
Fracture
|
2.0%
2/102 • Number of events 2 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Injury, poisoning and procedural complications
Renal lymphocele
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Metabolism and nutrition disorders
Hyperkaliemia
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 3 • 8 years, 8 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Nervous system disorders
Encephalopathy
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Nervous system disorders
metabolic encephalopathy
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Psychiatric disorders
Alcohol withdrawal
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
2.0%
2/100 • Number of events 2 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 2 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
2/102 • Number of events 2 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
2.0%
2/100 • Number of events 2 • 8 years, 8 months
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
2/102 • Number of events 2 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
2.0%
2/100 • Number of events 2 • 8 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary disease
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Social circumstances
Homeless
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Surgical and medical procedures
Alcohol detoxification
|
2.0%
2/102 • Number of events 10 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Surgical and medical procedures
Amputation
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Surgical and medical procedures
Intraocular Lens Implant
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.98%
1/102 • Number of events 2 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage IV
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Investigations
Catheterisation cardiac
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Product Issues
Device occlusion
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
Other adverse events
| Measure |
Fidaxomicin
n=102 participants at risk
Standard 10-day fidaxomicin treatment for Clostridium difficile
Fidaxomicin: 200 mg PO twice daily for 10 days
|
Vancomycin T/P
n=100 participants at risk
Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile
Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
|
Vancomycin
n=100 participants at risk
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Infections and infestations
Clostridioide difficile infection
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Infections and infestations
Fungal infection
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Infections and infestations
Conjunctivitis
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Investigations
Hepatic enzyme increased
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
3.0%
3/100 • Number of events 3 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Investigations
White blood cell count
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Investigations
Alanine aminotransferase
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
2.0%
2/100 • Number of events 2 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Investigations
Neutrophil count decrease
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.98%
1/102 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
General disorders
Fatigue
|
0.00%
0/102 • 8 years, 8 months
|
2.0%
2/100 • Number of events 2 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
General disorders
Malaise
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/102 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
|
Gastrointestinal disorders
Dysepsia
|
0.00%
0/102 • 8 years, 8 months
|
0.00%
0/100 • 8 years, 8 months
|
1.0%
1/100 • Number of events 1 • 8 years, 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place