Trial Outcomes & Findings for Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection (NCT NCT03595553)

Last Updated: 2023-03-03

Results Overview

This primary outcome measures the number of participants with Sustained Clinical Response (SCR). SCR is defined as Clinical Response and no recurrence of CDI through 30 days post End of Treatment (EOT). At D40, D70 and D100 the Investigator or medically qualified designee will determine if the patient has a sustained clinical response or experienced RECURRENCE since the previous assessment. The Investigator will assess cure/failure and recurrence based on available information which includes, but is not limited to, improvement from baseline in the number of UBMs, signs \& symptoms of CDI, and the requirement for CDI medication. The Investigator should assess cure/failure in a way that best reflects the Investigator's standard clinical practice.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

759 participants

Primary outcome timeframe

Day 40

Results posted on

2023-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Ridinilazole ridinilazole (200 mg bid), coated tablet, oral route of administration.	Vancomycin vancomycin (125 mg qid), hard capsule, oral route of administration.
Overall Study STARTED	370	375
Overall Study COMPLETED	312	327
Overall Study NOT COMPLETED	58	48

Reasons for withdrawal

Reasons for withdrawal
Measure	Ridinilazole ridinilazole (200 mg bid), coated tablet, oral route of administration.	Vancomycin vancomycin (125 mg qid), hard capsule, oral route of administration.
Overall Study Withdrawal by Subject	20	8
Overall Study Physician Decision	3	2
Overall Study Adverse Event	2	5
Overall Study Death	24	22
Overall Study Lost to Follow-up	6	7
Overall Study Other as indicated in CSR	3	3
Overall Study Sponsor Decision	0	1

Baseline Characteristics

Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ridinilazole n=370 Participants ridinilazole: ridinilazole (200 mg bid)	Vancomycin n=375 Participants vancomycin: vancomycin (125 mg qid)	Total n=745 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	209 Participants n=93 Participants	213 Participants n=4 Participants	422 Participants n=27 Participants
Age, Categorical >=65 years	161 Participants n=93 Participants	162 Participants n=4 Participants	323 Participants n=27 Participants
Age, Continuous	59.1 years STANDARD_DEVIATION 17.89 • n=93 Participants	59.6 years STANDARD_DEVIATION 17.42 • n=4 Participants	59.4 years STANDARD_DEVIATION 17.64 • n=27 Participants
Sex: Female, Male Female	209 Participants n=93 Participants	227 Participants n=4 Participants	436 Participants n=27 Participants
Sex: Female, Male Male	161 Participants n=93 Participants	148 Participants n=4 Participants	309 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants n=93 Participants	60 Participants n=4 Participants	100 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	322 Participants n=93 Participants	305 Participants n=4 Participants	627 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=93 Participants	10 Participants n=4 Participants	18 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	11 Participants n=93 Participants	10 Participants n=4 Participants	21 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	10 Participants n=93 Participants	16 Participants n=4 Participants	26 Participants n=27 Participants
Race (NIH/OMB) White	333 Participants n=93 Participants	331 Participants n=4 Participants	664 Participants n=27 Participants
Race (NIH/OMB) More than one race	8 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=93 Participants	10 Participants n=4 Participants	17 Participants n=27 Participants
Region of Enrollment United States	81 participants n=93 Participants	87 participants n=4 Participants	168 participants n=27 Participants
Region of Enrollment Canada	12 participants n=93 Participants	17 participants n=4 Participants	29 participants n=27 Participants
Region of Enrollment Europe	229 participants n=93 Participants	220 participants n=4 Participants	449 participants n=27 Participants
Region of Enrollment Mexico	5 participants n=93 Participants	11 participants n=4 Participants	16 participants n=27 Participants
Region of Enrollment Brazil	3 participants n=93 Participants	10 participants n=4 Participants	13 participants n=27 Participants
Region of Enrollment Chile	2 participants n=93 Participants	3 participants n=4 Participants	5 participants n=27 Participants
Region of Enrollment Argentina	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants
Region of Enrollment Peru	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants
Region of Enrollment Israel	17 participants n=93 Participants	15 participants n=4 Participants	32 participants n=27 Participants
Region of Enrollment South Korea	10 participants n=93 Participants	9 participants n=4 Participants	19 participants n=27 Participants
Region of Enrollment Australia	6 participants n=93 Participants	2 participants n=4 Participants	8 participants n=27 Participants
Region of Enrollment New Zealand	3 participants n=93 Participants	1 participants n=4 Participants	4 participants n=27 Participants
BMI	26.64 kg/m^2 STANDARD_DEVIATION 5.729 • n=93 Participants	26.36 kg/m^2 STANDARD_DEVIATION 5.732 • n=4 Participants	26.54 kg/m^2 STANDARD_DEVIATION 5.748 • n=27 Participants

PRIMARY outcome

Timeframe: Day 40

Outcome measures

Outcome measures
Measure	Ridinilazole n=370 Participants ridinilazole: ridinilazole (200 mg bid)	Vancomycin n=375 Participants vancomycin: vancomycin (125 mg qid)
Number of Participants With Sustained Clinical Response (SCR) Defined as Clinical Response and no Recurrence of CDI Through 30 Days Post End of Treatment (EOT). SCR based on Clinical Cure	238 Participants	225 Participants
Number of Participants With Sustained Clinical Response (SCR) Defined as Clinical Response and no Recurrence of CDI Through 30 Days Post End of Treatment (EOT). SCR based on Clinical Cure Failure	132 Participants	150 Participants

SECONDARY outcome

Timeframe: Day 12

defined as * less than 3 unformed bowel movements (UBMs) for consecutive days and maintained through EOT without further CDI treatment at EOT + 2 days, or * the investigator's assessment that the subject no longer needs specific CDI antimicrobial treatment after completion of the course of study medication.

Outcome measures

Outcome measures
Measure	Ridinilazole n=370 Participants ridinilazole: ridinilazole (200 mg bid)	Vancomycin n=375 Participants vancomycin: vancomycin (125 mg qid)
Clinical Response Clinical Response	320 Participants	346 Participants
Clinical Response Clinical Response Failure	50 Participants	29 Participants

SECONDARY outcome

Timeframe: Day 12

defined as the resolution of diarrhea (\<3 UBMs in the 1-day period immediately prior to EOT, that is maintained for 2 days after EOT).

Outcome measures

Outcome measures
Measure	Ridinilazole n=370 Participants ridinilazole: ridinilazole (200 mg bid)	Vancomycin n=375 Participants vancomycin: vancomycin (125 mg qid)
Clinical Cure Clinical Cure	275 Participants	292 Participants
Clinical Cure Clinical Cure Failure	95 Participants	83 Participants

SECONDARY outcome

Timeframe: Day 70

defined as Clinical Response and no recurrence of CDI through 60 days post EOT

Outcome measures

Outcome measures
Measure	Ridinilazole n=370 Participants ridinilazole: ridinilazole (200 mg bid)	Vancomycin n=375 Participants vancomycin: vancomycin (125 mg qid)
Sustained Clinical Response Over 60 Days Sustained Clinical Response 60 Days Post EOT	262 Participants	258 Participants
Sustained Clinical Response Over 60 Days Sustained Clinical Response 60 Days Post EOT Failure	108 Participants	117 Participants

SECONDARY outcome

Timeframe: Day 100

defined as Clinical Response and no recurrence of CDI through 90 days post EOT

Outcome measures

Outcome measures
Measure	Ridinilazole n=370 Participants ridinilazole: ridinilazole (200 mg bid)	Vancomycin n=375 Participants vancomycin: vancomycin (125 mg qid)
Sustained Clinical Response Over 90 Days Sustained Clinical Response 90 Days Post EOT Failure	111 Participants	126 Participants
Sustained Clinical Response Over 90 Days Sustained Clinical Response 90 Days Post EOT	259 Participants	249 Participants

SECONDARY outcome

Timeframe: Day 10

This secondary outcome measures the relative abundance of the 3 main Bile Acid Groups (Conjugated Primary, Primary and Secondary Bile Acids) from Baseline to EOT.

Outcome measures

Outcome measures
Measure	Ridinilazole n=370 Participants ridinilazole: ridinilazole (200 mg bid)	Vancomycin n=375 Participants vancomycin: vancomycin (125 mg qid)
Relative Abundance of the 3 Main Bile Acid Groups (Conjugated Primary, Primary and Secondary Bile Acids) From Baseline to EOT. Secondary Bile Acid Group at Baseline	33.34 percentage of abundance Standard Deviation 35.68	30.25 percentage of abundance Standard Deviation 34.13
Relative Abundance of the 3 Main Bile Acid Groups (Conjugated Primary, Primary and Secondary Bile Acids) From Baseline to EOT. Secondary Bile Acid Group at EOT	38.13 percentage of abundance Standard Deviation 39.63	7.87 percentage of abundance Standard Deviation 22.69
Relative Abundance of the 3 Main Bile Acid Groups (Conjugated Primary, Primary and Secondary Bile Acids) From Baseline to EOT. Primary Bile Acid Group at Baseline	55.03 percentage of abundance Standard Deviation 34.06	57.44 percentage of abundance Standard Deviation 33.08
Relative Abundance of the 3 Main Bile Acid Groups (Conjugated Primary, Primary and Secondary Bile Acids) From Baseline to EOT. Primary Bile Acid Group at EOT	55.99 percentage of abundance Standard Deviation 38.06	65.72 percentage of abundance Standard Deviation 33.90
Relative Abundance of the 3 Main Bile Acid Groups (Conjugated Primary, Primary and Secondary Bile Acids) From Baseline to EOT. Conjugated Primary Bile Acid Group at Baseline	11.64 percentage of abundance Standard Deviation 21.93	12.31 percentage of abundance Standard Deviation 21.56
Relative Abundance of the 3 Main Bile Acid Groups (Conjugated Primary, Primary and Secondary Bile Acids) From Baseline to EOT. Conjugated Primary Bile Acid Group at EOT	5.88 percentage of abundance Standard Deviation 15.50	26.42 percentage of abundance Standard Deviation 31.62

SECONDARY outcome

Timeframe: Day 10

This secondary outcome measures the percentage of change of α-diversity (Shannon Index) of the microbiota in stool samples from baseline to EOT. Shannon index is a weighted statistic measuring both species richness and evenness. The Shannon Index is calculated by taking the relative abundance of each species and sums the relative abundance times the natural log of the relative abundance for each species. The value is converted into a positive value by times minus one. A higher Shannon Index means higher diversity

Outcome measures

Outcome measures
Measure	Ridinilazole n=272 Participants ridinilazole: ridinilazole (200 mg bid)	Vancomycin n=280 Participants vancomycin: vancomycin (125 mg qid)
Percentage of Change of α-diversity (Shannon Index) of the Microbiota in Stool Samples From Baseline to EOT.	37.06 percent change in Shannon Index Interval 6.01 to 68.11	-7.32 percent change in Shannon Index Interval -16.61 to 1.97

SECONDARY outcome

Timeframe: Day 10

This secondary outcome measures the β-diversity of the gut microbiota in stool samples from baseline to EOT. Bray-Curtis index/dissimilarity measures how different two samples are in the microbiome composition. The Bray-Curtis dissimilarity is graded between 0 and 1, where 0 means the two samples have the same composition (that is they share all the species and every species has the same abundance), and 1 means the two samples do not share any species.

Outcome measures

Outcome measures
Measure	Ridinilazole n=272 Participants ridinilazole: ridinilazole (200 mg bid)	Vancomycin n=280 Participants vancomycin: vancomycin (125 mg qid)
Measure of β-diversity of the Gut Microbiota Between Baseline and EOT Stool Samples (Bray-Curtis Index/Dissimilarity).	0.7 Bray-Curtis Index Interval 0.68 to 0.72	0.81 Bray-Curtis Index Interval 0.79 to 0.83

Adverse Events

RIDINILAZOLE 200 MG

Serious events: 32 serious events

Other events: 124 other events

Deaths: 26 deaths

VANCOMYCIN 125 MG

Serious events: 30 serious events

Other events: 117 other events

Deaths: 24 deaths

Serious adverse events

Other adverse events

Additional Information

Katie Tran

Summit Therapeutics

Phone: 408 677 6503

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Serious adverse events
Measure	RIDINILAZOLE 200 MG n=374 participants at risk RIDINILAZOLE 200mg bid, coated tablet, oral route of administration.	VANCOMYCIN 125 MG n=377 participants at risk VANCOMYCIN 125mg qid, hard capsule, oral route of administration.
Infections and infestations Abdominal abscess	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Cardiac disorders Acute myocardial infarction	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Respiratory, thoracic and mediastinal disorders Asthma	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Cardiac disorders Cardiac failure	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Cardiac disorders Cardiac failure congestive	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Nervous system disorders Cerebrovascular accident	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Hepatobiliary disorders Cholecystitis acute	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Renal and urinary disorders Chronic kidney disease	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations Clostridium difficile infection	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.53% 2/377 • Number of events 2 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations COVID-19	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations COVID-19 pneumonia	0.80% 3/374 • Number of events 3 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.80% 3/377 • Number of events 3 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Metabolism and nutrition disorders Dehydration	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations Diverticulitis	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Immune system disorders Drug hypersensitivity	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations Empyema	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations Endocarditis	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations Enterobacter infection	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Gastrointestinal disorders Enterocolitis haemorrhagic	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations Escherichia infection	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations Escherichia sepsis	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.53% 2/377 • Number of events 2 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations Escherichia urinary tract infection	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Vascular disorders Extremity necrosis	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Gastrointestinal disorders Gastric ulcer	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Gastrointestinal disorders Haematochezia	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Vascular disorders Haemodynamic instability	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Blood and lymphatic system disorders Haemolytic uraemic syndrome	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations HCoV-OC43 infection	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Injury, poisoning and procedural complications Hip fracture	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Metabolism and nutrition disorders Hypokalaemia	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Cardiac disorders Ischaemic cardiomyopathy	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations Klebsiella infection	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations Klebsiella sepsis	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Cardiac disorders Left ventricular failure	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Ear and labyrinth disorders Meniere's disease	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Gastrointestinal disorders Mesenteric vein thrombosis	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
General disorders Multiple organ dysfunction syndrome	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Gastrointestinal disorders Nausea	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Renal and urinary disorders Nephropathy	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.

Other adverse events
Measure	RIDINILAZOLE 200 MG n=374 participants at risk RIDINILAZOLE 200mg bid, coated tablet, oral route of administration.	VANCOMYCIN 125 MG n=377 participants at risk VANCOMYCIN 125mg qid, hard capsule, oral route of administration.
Gastrointestinal disorders Abdominal discomfort	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Gastrointestinal disorders Abdominal distension	1.1% 4/374 • Number of events 4 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Gastrointestinal disorders Abdominal pain	1.9% 7/374 • Number of events 9 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	1.9% 7/377 • Number of events 7 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Gastrointestinal disorders Abdominal pain lower	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Gastrointestinal disorders Abdominal pain upper	1.3% 5/374 • Number of events 5 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Renal and urinary disorders Acute kidney injury	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Psychiatric disorders Agitation	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Investigations Alanine aminotransferase increased	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.53% 2/377 • Number of events 2 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Blood and lymphatic system disorders Anaemia	1.6% 6/374 • Number of events 6 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	1.6% 6/377 • Number of events 6 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Gastrointestinal disorders Anal incontinence	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Cardiac disorders Angina pectoris	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Injury, poisoning and procedural complications Animal scratch	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Psychiatric disorders Anxiety	0.53% 2/374 • Number of events 2 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Musculoskeletal and connective tissue disorders Arthralgia	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	1.6% 6/377 • Number of events 7 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Musculoskeletal and connective tissue disorders Arthritis	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Gastrointestinal disorders Ascites	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Investigations Aspartate aminotransferase increased	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.80% 3/377 • Number of events 3 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
General disorders Asthenia	0.53% 2/374 • Number of events 3 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Respiratory, thoracic and mediastinal disorders Asthma	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations Asymptomatic COVID-19	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Cardiac disorders Atrial fibrillation	0.80% 3/374 • Number of events 3 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Musculoskeletal and connective tissue disorders Back pain	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.53% 2/377 • Number of events 2 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations Bacteraemia	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations Bacteriuria	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Vascular disorders Bleeding varicose vein	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 2 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Investigations Blood albumin decreased	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Investigations Blood alkaline phosphatase increased	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Investigations Blood creatinine increased	0.80% 3/374 • Number of events 3 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Investigations Blood potassium decreased	0.53% 2/374 • Number of events 2 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Investigations Blood potassium increased	0.53% 2/374 • Number of events 2 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Investigations Blood urea increased	0.53% 2/374 • Number of events 2 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Investigations Blood uric acid increased	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations Bronchitis	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Nervous system disorders Burning sensation	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 2 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/374 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.27% 1/377 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.
Infections and infestations Candida infection	0.27% 1/374 • Number of events 1 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.	0.00% 0/377 • All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit. The number of participants (both arms: ridinilazole and vancomycin) in Participant Flow module is different than the Adverse Event Results. The Participant Flow module reflects mITT population, whereas Adverse Event Results population reflects Safety Population. mITT Population patients did not have positive free toxin/CCNA Test and/or \>=3 UBM at Baseline. Safety Population only requires treated subjects.