Trial Outcomes & Findings for Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005) (NCT NCT01597505)
NCT ID: NCT01597505
Last Updated: 2019-07-23
Results Overview
A clinical outcome of cure at EOT was determined by resolution of diarrhea, defined as ≤ 2 loose stools per 24-hour period for at least 2 consecutive days and the lack of need for additional antibiotics to treat the current CDAD episode after completion of the study treatment period. Participants requiring a collection device were considered to have resolution of diarrhea when the volume of stool (over a 24-hour period) was decreased by 75% as compared to baseline or the participant was no longer passing liquid stool. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
606 participants
Primary outcome timeframe
Up to 13 days
Results posted on
2019-07-23
Participant Flow
Males and females aged 18 years or older with diarrhea at risk for Clostridium Difficile Associated Diarrhea (CDAD) were enrolled in this study
Participant milestones
| Measure |
Surotomycin
250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days
|
Vancomycin
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Overall Study
STARTED
|
308
|
298
|
|
Overall Study
Treated
|
305
|
286
|
|
Overall Study
COMPLETED
|
264
|
265
|
|
Overall Study
NOT COMPLETED
|
44
|
33
|
Reasons for withdrawal
| Measure |
Surotomycin
250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days
|
Vancomycin
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Overall Study
Physician Decision
|
5
|
0
|
|
Overall Study
Adverse Event
|
19
|
7
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
10
|
18
|
|
Overall Study
Other
|
5
|
6
|
|
Overall Study
Missing
|
1
|
0
|
Baseline Characteristics
Randomized participants with Confirmed CDAD
Baseline characteristics by cohort
| Measure |
Surotomycin
n=308 Participants
250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days
|
Vancomycin
n=298 Participants
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
Total
n=606 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.5 Years
STANDARD_DEVIATION 17.5 • n=308 Participants
|
61.8 Years
STANDARD_DEVIATION 18.4 • n=298 Participants
|
61.6 Years
STANDARD_DEVIATION 17.9 • n=606 Participants
|
|
Age, Customized
< 75 years old
|
211 Participants
n=290 Participants • Randomized participants with Confirmed CDAD
|
200 Participants
n=280 Participants • Randomized participants with Confirmed CDAD
|
411 Participants
n=570 Participants • Randomized participants with Confirmed CDAD
|
|
Age, Customized
>= 75 years old
|
79 Participants
n=290 Participants • Randomized participants with Confirmed CDAD
|
80 Participants
n=280 Participants • Randomized participants with Confirmed CDAD
|
159 Participants
n=570 Participants • Randomized participants with Confirmed CDAD
|
|
Sex: Female, Male
Female
|
185 Participants
n=308 Participants
|
175 Participants
n=298 Participants
|
360 Participants
n=606 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=308 Participants
|
123 Participants
n=298 Participants
|
246 Participants
n=606 Participants
|
|
Previous episodes of CDAD
0 Previous Episodes
|
237 Participants
n=286 Participants • Randomized participants with Confirmed CDAD evaluated for previous episodes of CDAD
|
224 Participants
n=275 Participants • Randomized participants with Confirmed CDAD evaluated for previous episodes of CDAD
|
461 Participants
n=561 Participants • Randomized participants with Confirmed CDAD evaluated for previous episodes of CDAD
|
|
Previous episodes of CDAD
>= 1 Previous Episodes
|
49 Participants
n=286 Participants • Randomized participants with Confirmed CDAD evaluated for previous episodes of CDAD
|
51 Participants
n=275 Participants • Randomized participants with Confirmed CDAD evaluated for previous episodes of CDAD
|
100 Participants
n=561 Participants • Randomized participants with Confirmed CDAD evaluated for previous episodes of CDAD
|
|
BI/NAP1/027 Strain
With BI/NAP1/027 Strain
|
59 Participants
n=255 Participants • Randomized participants with Confirmed CDAD evaluated for BI/NAP1/027 Strain
|
67 Participants
n=246 Participants • Randomized participants with Confirmed CDAD evaluated for BI/NAP1/027 Strain
|
126 Participants
n=501 Participants • Randomized participants with Confirmed CDAD evaluated for BI/NAP1/027 Strain
|
|
BI/NAP1/027 Strain
Without BI/NAP1/027 Strain
|
196 Participants
n=255 Participants • Randomized participants with Confirmed CDAD evaluated for BI/NAP1/027 Strain
|
179 Participants
n=246 Participants • Randomized participants with Confirmed CDAD evaluated for BI/NAP1/027 Strain
|
375 Participants
n=501 Participants • Randomized participants with Confirmed CDAD evaluated for BI/NAP1/027 Strain
|
PRIMARY outcome
Timeframe: Up to 13 daysPopulation: The population analyzed is the Microbiological Modified Intent-To-Treat (mMITT) population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.
A clinical outcome of cure at EOT was determined by resolution of diarrhea, defined as ≤ 2 loose stools per 24-hour period for at least 2 consecutive days and the lack of need for additional antibiotics to treat the current CDAD episode after completion of the study treatment period. Participants requiring a collection device were considered to have resolution of diarrhea when the volume of stool (over a 24-hour period) was decreased by 75% as compared to baseline or the participant was no longer passing liquid stool. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.
Outcome measures
| Measure |
Surotomycin
n=290 Participants
250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
|
Vancomycin
n=280 Participants
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT)
|
79.0 Percentage of participants
Interval 73.9 to 83.2
|
83.6 Percentage of participants
Interval 78.8 to 87.4
|
PRIMARY outcome
Timeframe: Up to Day 50Population: All randomized participants who received any amount of study drug
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings).
Outcome measures
| Measure |
Surotomycin
n=305 Participants
250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
|
Vancomycin
n=286 Participants
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Percentage of Participants With at Least One Adverse Event (AE)
|
48.5 Percentage of participants
|
55.2 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Day 50Population: All randomized participants who received any amount of study drug
A SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death; a life-threatening experience, referring to a situation in which the participant was at risk of death at the time of the event, requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; or is considered to be an important medical event.
Outcome measures
| Measure |
Surotomycin
n=305 Participants
250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
|
Vancomycin
n=286 Participants
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Percentage of Participants With at Least One Serious Adverse Event (SAE)
|
14.4 Percentage of participants
|
12.9 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Day 13Population: All randomized participants who received any amount of study drug
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings).
Outcome measures
| Measure |
Surotomycin
n=305 Participants
250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
|
Vancomycin
n=286 Participants
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Percentage of Participants Who Discontinued Treatment Due to an AE
|
5.6 Percentage of participants
|
2.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 41Population: The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized
Clinical response over time as measured by those without treatment failure, recurrence, death, or lost to follow-up, measured as the number of participants without failure events (survivors) through the end of therapy (reported for Day 14) and from end of therapy to Day 40 (reported for Day 41).
Outcome measures
| Measure |
Surotomycin
n=290 Participants
250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
|
Vancomycin
n=280 Participants
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Number of Participants With Clinical Response Over Time
Day 14
|
227 Participants
|
231 Participants
|
|
Number of Participants With Clinical Response Over Time
Day 41
|
147 Participants
|
151 Participants
|
SECONDARY outcome
Timeframe: Up to Day 50Population: The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.
Sustained clinical response at the end of study was achieved by participants who had a clinical outcome of cure at the end of treatment (Days 40-50) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Outcome measures
| Measure |
Surotomycin
n=290 Participants
250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
|
Vancomycin
n=280 Participants
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Adjusted Percentage of Participants With Sustained Clinical Response at the End of Study
|
60.6 Percentage of participants
Interval 55.0 to 66.0
|
61.4 Percentage of participants
Interval 55.9 to 66.8
|
SECONDARY outcome
Timeframe: Day 24Population: The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.
Sustained clinical response at Day 24 was defined as participants who had a clinical outcome of cure at Day 24, who did not experience a recurrence of CDAD, did not die, were not lost to follow-up. Only the first failure event was counted per participant. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Outcome measures
| Measure |
Surotomycin
n=290 Participants
250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
|
Vancomycin
n=280 Participants
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Adjusted Percentage of Participants With Sustained Clinical Response at Day 24
|
66.6 Percentage of participants
Interval 61.1 to 71.8
|
66.1 Percentage of participants
Interval 60.5 to 71.3
|
SECONDARY outcome
Timeframe: Up to Day 50Population: The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.
Participants with recurrences were defined as those who were cured at the end of therapy and had a recurrence or were lost to follow-up, died or had a Day 40 -50 contact prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Outcome measures
| Measure |
Surotomycin
n=290 Participants
250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
|
Vancomycin
n=280 Participants
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Adjusted Percentage of Participants With Recurrence of CDAD at End of Study
|
17.7 Percentage of participants
Interval 13.8 to 22.4
|
21.2 Percentage of participants
Interval 16.9 to 26.1
|
SECONDARY outcome
Timeframe: Up to Day 13Population: The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized
Time to resolution of diarrhea with =\< 2 unformed bowel movements (UBM) per 24-hour period was calculated as the date/time of last UBM minus the date/time of the first dose of study drug.
Outcome measures
| Measure |
Surotomycin
n=290 Participants
250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
|
Vancomycin
n=280 Participants
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Time to Resolution of Diarrhea
|
2.8 Days
Interval 2.2 to 3.3
|
3.0 Days
Interval 2.2 to 3.3
|
SECONDARY outcome
Timeframe: Up to Day 50Population: The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized; and were cured at end of treatment.
Time to reappearance of diarrhea with \>= 3 UBM per 24-hour period was calculated as the last date/time of study drug dose to the date/time of first reappearance of 3 or more UBMs among participants who were cured at end of treatment.
Outcome measures
| Measure |
Surotomycin
n=229 Participants
250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
|
Vancomycin
n=234 Participants
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Time to Reappearance of Diarrhea From End of Treatment to the End of Study
|
NA Days
The median value was not achieved
|
NA Days
The median value was not achieved
|
SECONDARY outcome
Timeframe: Up to Day 13Population: Randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized; and with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline.
Clinical response corresponded to a clinical outcome of cure at the end of treatment, and was achieved by participants with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline, who did not fail treatment, did not die, or were not lost to follow-up at the end of treatment. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Outcome measures
| Measure |
Surotomycin
n=59 Participants
250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
|
Vancomycin
n=67 Participants
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Adjusted Percentage of Participants With a Clinical Response at the End of Treatment for Infections Deemed to be Caused by the C. Difficile BI/NAP1/027 Strain at Baseline
|
88.5 Percentage of participants
Interval 75.8 to 92.4
|
86.3 Percentage of participants
Interval 76.2 to 92.6
|
SECONDARY outcome
Timeframe: Up to Day 13Population: The population analyzed is the Per Protocol 1 (PP1) population composed of participants from the mMITT population, according to the actual treatment they received; without any protocol deviations from enrollment through 2 days after end of treatment, which could affect the efficacy conclusions.
Clinical response corresponded to a clinical outcome of cure at the end of treatment, and was achieved by participants who did not fail treatment, did not die, or were not lost to follow-up at the end of treatment. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Outcome measures
| Measure |
Surotomycin
n=252 Participants
250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
|
Vancomycin
n=243 Participants
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Adjusted Percentage of Participants Per Protocol 1 Population With a Clinical Response at the End of Treatment
|
89.1 Percentage of participants
Interval 84.5 to 92.2
|
91.5 Percentage of participants
Interval 87.2 to 94.3
|
SECONDARY outcome
Timeframe: Up to Day 50Population: All randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized; and with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline
Sustained clinical response at the end of study was achieved by participants with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline, who had a clinical outcome of cure at the end of treatment (Day 13) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Outcome measures
| Measure |
Surotomycin
n=59 Participants
250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
|
Vancomycin
n=67 Participants
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Adjusted Percentage of Participants With a Sustained Clinical Response at the End of Study for Infections Deemed to be Caused by the C. Difficile BI/NAP1/027 Strain at Baseline
|
66.1 Percentage of participants
Interval 53.6 to 76.7
|
51.5 Percentage of participants
Interval 40.5 to 63.1
|
SECONDARY outcome
Timeframe: Up to Day 50Population: The Per Protocol 2 (PP2) population composed of cures and failures from the PP1 population. Additionally, to be included in the PP2 population, PP1 participants who were cured at end of treatment must not have had any protocol deviations which could affect the assessment of recurrence and have had follow-up contact through at least Day 40.
Sustained clinical response at the end of study was achieved by participants who had a clinical outcome of cure at the end of treatment (Days 40-50) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. Only the first failure event per participant was counted. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Outcome measures
| Measure |
Surotomycin
n=233 Participants
250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days
|
Vancomycin
n=227 Participants
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Adjusted Percentage of Participants From the Per Protocol 2 Population With a Sustained Clinical Response at the End of Study
|
70.8 Percentage of participants
Interval 64.8 to 76.2
|
66.5 Percentage of participants
Interval 60.6 to 72.2
|
Adverse Events
Surotomycin
Serious events: 44 serious events
Other events: 38 other events
Deaths: 18 deaths
Vancomycin
Serious events: 37 serious events
Other events: 38 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Surotomycin
n=305 participants at risk
250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 for 10 days
|
Vancomycin
n=286 participants at risk
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.98%
3/305 • Number of events 3 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.98%
3/305 • Number of events 4 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.66%
2/305 • Number of events 2 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Jejunal ulcer perforation
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Megacolon
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
General disorders
Death
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
General disorders
Pyrexia
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
General disorders
Sudden cardiac death
|
0.66%
2/305 • Number of events 2 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Abscess
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Bronchitis
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Bronchopneumonia
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Escherichia sepsis
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Fungal peritonitis
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Peritonitis
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Peritonitis bacterial
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Pneumonia
|
0.98%
3/305 • Number of events 3 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Sepsis
|
0.66%
2/305 • Number of events 2 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Strongyloidiasis
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.70%
2/286 • Number of events 2 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
1.0%
3/286 • Number of events 3 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Nervous system disorders
Tonic convulsion
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.70%
2/286 • Number of events 2 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
1.0%
3/286 • Number of events 3 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.70%
2/286 • Number of events 2 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Vascular disorders
Hypotension
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/305 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.35%
1/286 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Vascular disorders
Shock haemorrhagic
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Vascular disorders
Venous thrombosis limb
|
0.33%
1/305 • Number of events 1 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
0.00%
0/286 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
Other adverse events
| Measure |
Surotomycin
n=305 participants at risk
250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 for 10 days
|
Vancomycin
n=286 participants at risk
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.2%
16/305 • Number of events 20 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
2.1%
6/286 • Number of events 6 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Nausea
|
6.6%
20/305 • Number of events 23 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
7.3%
21/286 • Number of events 21 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
|
Nervous system disorders
Headache
|
3.9%
12/305 • Number of events 13 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
6.3%
18/286 • Number of events 21 • All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
All randomized participants who received any amount of study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place