Trial Outcomes & Findings for A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006) (NCT NCT01598311)
NCT ID: NCT01598311
Last Updated: 2022-08-22
Results Overview
The percentage of participants considered "cured" (i.e., ≤2 loose stools per 24 hour period for at least 2 consecutive days and no need for additional antibiotics during the 3 days following EOT) was determined in the mMITT population. A CDAD diagnosis was defined as: 1) diarrhea with a minimum of 3 unformed bowel movements (UBM) or \>200 mL volume of stool for participants with a collection device (e.g., rectal tube or colostomy bag) over 24 hours; and 2) a positive result for Clostridium difficile toxin by enzyme immunoassay (EIA), polymerase chain reaction (PCR), or a cell culture cytotoxin neutralization assay. Percentages were first stratified according to age (\<75 or ≥75 years) and number of previous CDAD episodes (0 or ≥1) and constructed using Mehrotra-Railkar continuity-corrected minimum-risk stratum weights, and the weighted averages were then derived across strata in order to calculate the adjusted percentage.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
608 participants
Primary outcome timeframe
Up to 3 days after EOT (up to Day 13)
Results posted on
2022-08-22
Participant Flow
This study enrolled adult participants with Clostridium Difficile associated diarrhea (CDAD) at 104 study centers in North America, Asia-Pacific, and South America.
Participant milestones
| Measure |
CB-183,315
Participants took CB-183,315 250 mg twice daily (b.i.d.) and placebo b.i.d. by mouth for 10 days.
|
Vancomycin
Participants took vancomycin 125 mg four times daily (q.i.d.) by mouth for 10 days.
|
|---|---|---|
|
Overall Study
STARTED
|
303
|
305
|
|
Overall Study
Treated
|
294
|
301
|
|
Overall Study
Treated and Confirmed CDAD
|
285
|
292
|
|
Overall Study
COMPLETED
|
256
|
244
|
|
Overall Study
NOT COMPLETED
|
47
|
61
|
Reasons for withdrawal
| Measure |
CB-183,315
Participants took CB-183,315 250 mg twice daily (b.i.d.) and placebo b.i.d. by mouth for 10 days.
|
Vancomycin
Participants took vancomycin 125 mg four times daily (q.i.d.) by mouth for 10 days.
|
|---|---|---|
|
Overall Study
Physician Decision
|
4
|
5
|
|
Overall Study
Adverse Event
|
9
|
13
|
|
Overall Study
Lost to Follow-up
|
7
|
12
|
|
Overall Study
Withdrawal by Subject
|
9
|
13
|
|
Overall Study
No reason provided.
|
0
|
5
|
|
Overall Study
Randomized but never treated
|
8
|
5
|
|
Overall Study
Treated but no confirmed CDAD
|
9
|
8
|
|
Overall Study
Assigned to CB but received vancomycin
|
1
|
0
|
Baseline Characteristics
A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)
Baseline characteristics by cohort
| Measure |
CB-183,315
n=285 Participants
Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
|
Vancomycin
n=292 Participants
Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
|
Total
n=577 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 Years
STANDARD_DEVIATION 18.3 • n=93 Participants
|
56.5 Years
STANDARD_DEVIATION 18.3 • n=4 Participants
|
57.1 Years
STANDARD_DEVIATION 18.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=93 Participants
|
194 Participants
n=4 Participants
|
367 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=93 Participants
|
98 Participants
n=4 Participants
|
210 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 3 days after EOT (up to Day 13)Population: The analysis population consists of all randomized and treated participants with a confirmed CDAD diagnosis (mMITT population).
The percentage of participants considered "cured" (i.e., ≤2 loose stools per 24 hour period for at least 2 consecutive days and no need for additional antibiotics during the 3 days following EOT) was determined in the mMITT population. A CDAD diagnosis was defined as: 1) diarrhea with a minimum of 3 unformed bowel movements (UBM) or \>200 mL volume of stool for participants with a collection device (e.g., rectal tube or colostomy bag) over 24 hours; and 2) a positive result for Clostridium difficile toxin by enzyme immunoassay (EIA), polymerase chain reaction (PCR), or a cell culture cytotoxin neutralization assay. Percentages were first stratified according to age (\<75 or ≥75 years) and number of previous CDAD episodes (0 or ≥1) and constructed using Mehrotra-Railkar continuity-corrected minimum-risk stratum weights, and the weighted averages were then derived across strata in order to calculate the adjusted percentage.
Outcome measures
| Measure |
CB-183,315
n=285 Participants
Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
|
Vancomycin
n=292 Participants
Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
|
|---|---|---|
|
Adjusted Percentage of Participants Meeting Clinical Response Criteria for Cure at End of Treatment (EOT)
|
83.4 Adjusted percentage of participants
Interval 78.7 to 87.2
|
82.1 Adjusted percentage of participants
Interval 77.2 to 85.9
|
PRIMARY outcome
Timeframe: Up to 30 days after EOT (up to Day 40)Population: The analysis population consists of all randomized and treated participants (Safety Population).
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.
Outcome measures
| Measure |
CB-183,315
n=294 Participants
Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
|
Vancomycin
n=301 Participants
Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
|
|---|---|---|
|
Percentage of Participants Experiencing an Adverse Event (AE)
|
52.4 Percentage of Participants
|
60.1 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to EOT (up to Day 10)Population: The analysis population consists of all randomized and treated participants (Safety Population).
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.
Outcome measures
| Measure |
CB-183,315
n=294 Participants
Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
|
Vancomycin
n=301 Participants
Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
|
|---|---|---|
|
Percentage of Participants Discontinuing From Study Treatment Due to an AE
|
3.7 Percentage of Participants
|
3.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after EOT (up to Day 40)Population: The analysis population consists of all randomized and treated participants with a confirmed CDAD diagnosis (mMITT population).
The total number of clinical failure events, which included treatment failure, CDAD recurrence, death, or being lost to follow-up, occurring during each time period was determined in each arm.
Outcome measures
| Measure |
CB-183,315
n=285 Participants
Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
|
Vancomycin
n=292 Participants
Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
|
|---|---|---|
|
Number of Clinical Failure Events up to Day 40
Day 0 to Day 13
|
48 Number of Failure Events
|
54 Number of Failure Events
|
|
Number of Clinical Failure Events up to Day 40
Day 14 to Day 24
|
42 Number of Failure Events
|
49 Number of Failure Events
|
|
Number of Clinical Failure Events up to Day 40
Day 25 to Day 35
|
11 Number of Failure Events
|
11 Number of Failure Events
|
|
Number of Clinical Failure Events up to Day 40
Day 36 to Day 40
|
2 Number of Failure Events
|
2 Number of Failure Events
|
SECONDARY outcome
Timeframe: Up to 40 days after EOT (up to Day 50)Population: The analysis population consists of all randomized and treated participants with a confirmed CDAD diagnosis (mMITT population).
The percentage of participants with sustained clinical response was determined for each arm. Sustained clinical response was declared when participants had a clinical outcome of cure at EOT, did not experience any CDAD recurrence, did not die, were not lost to follow-up, and did not have the end of study visit prior to Day 40. Percentages were first stratified according to age (\<75 or ≥75 years) and number of previous CDAD episodes (0 or ≥1) and constructed using Mehrotra-Railkar continuity-corrected minimum-risk stratum weights, and the weighted averages were then derived across strata in order to calculate the adjusted percentage.
Outcome measures
| Measure |
CB-183,315
n=285 Participants
Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
|
Vancomycin
n=292 Participants
Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
|
|---|---|---|
|
Adjusted Percentage of Participants With Sustained Clinical Response at End of Study
|
63.3 Adjusted percentage of participants
Interval 57.7 to 68.7
|
59.0 Adjusted percentage of participants
Interval 53.4 to 64.5
|
Adverse Events
CB-183,315
Serious events: 33 serious events
Other events: 53 other events
Deaths: 9 deaths
Vancomycin
Serious events: 39 serious events
Other events: 72 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
CB-183,315
n=294 participants at risk
Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
|
Vancomycin
n=301 participants at risk
Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.66%
2/301 • Number of events 2 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.4%
4/294 • Number of events 4 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.66%
2/301 • Number of events 2 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.66%
2/301 • Number of events 2 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Congenital, familial and genetic disorders
Sickle cell anaemia with crisis
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
1.3%
4/301 • Number of events 4 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
General disorders
Impaired healing
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Immune system disorders
Heart transplant rejection
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Infections and infestations
Abscess limb
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.68%
2/294 • Number of events 2 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Infections and infestations
Lobar pneumonia
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.0%
3/294 • Number of events 3 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.66%
2/301 • Number of events 2 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Infections and infestations
Serratia sepsis
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Vascular disorders
Femoral artery embolism
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/301 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/294 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Vascular disorders
Hypovolaemic shock
|
0.34%
1/294 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
0.33%
1/301 • Number of events 1 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
Other adverse events
| Measure |
CB-183,315
n=294 participants at risk
Participants took CB-183,315 250 mg b.i.d. and placebo b.i.d. by mouth for 10 days.
|
Vancomycin
n=301 participants at risk
Participants took vancomycin 125 mg q.i.d. by mouth for 10 days.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
8/294 • Number of events 9 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
7.3%
22/301 • Number of events 23 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
8.5%
25/294 • Number of events 25 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
7.6%
23/301 • Number of events 23 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
|
Nervous system disorders
Headache
|
10.5%
31/294 • Number of events 33 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose of study drug.
|
12.0%
36/301 • Number of events 38 • All AEs were collected up to Day 13; only serious AEs (SAEs) and drug-related AEs were collected up to Day 50.
The analysis population consists of all randomized participants who received ≥1 dose 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