Trial Outcomes & Findings for Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (NCT NCT01983683)

NCT ID: NCT01983683

Last Updated: 2025-02-04

Results Overview

Clinical Cure is defined as: • Resolution of Diarrhea (ROD) (≤ 3 unformed bowel movement (UBM) per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant (FMT) between first dose of study drug and 2 days after EOT (inclusive). CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

631 participants

Primary outcome timeframe

Up to Day 12 on average (end-of-treatment + 2 days)

Results posted on

2025-02-04

Participant Flow

1128 patients at 105 sites in 15 countries were screened, among whom 631 were randomized at 96 sites in 14 countries worldwide.

Among the 631 subjects randomized, 22 were excluded from all the analyses due to potential data integrity issues resulting in 609 total participants considered for the analyses. From the 22 excluded patients no serious adverse events (AEs) or study drug discontinuation information were reported. All reported AEs were mild or moderate in intensity.

Participant milestones

Participant milestones
Measure	Cadazolid Subjects with Clostridium difficile-associated diarrhea (CDAD) received oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times a day (qid) for 10 days. Subjects were followed up for 30 days after the last dose of cadazolid. Subjects who had a first recurrence of CDAD during the follow-up period were offered to enter a re-treatment extension period with cadazolid (10 days of cadazolid + 30-day follow up)	Vancomycin Subjects with CDAD received oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days. Subjects were followed up for 30 day after the last dose of vancomycin. Subjects who had a first recurrence of CDAD during the follow-up period were offered to enter a re-treatment extension period with cadazolid (10 days of cadazolid + 30-day follow up)
Overall Study STARTED	298	311
Overall Study COMPLETED	260	260
Overall Study NOT COMPLETED	38	51

Reasons for withdrawal

Reasons for withdrawal
Measure	Cadazolid Subjects with Clostridium difficile-associated diarrhea (CDAD) received oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times a day (qid) for 10 days. Subjects were followed up for 30 days after the last dose of cadazolid. Subjects who had a first recurrence of CDAD during the follow-up period were offered to enter a re-treatment extension period with cadazolid (10 days of cadazolid + 30-day follow up)	Vancomycin Subjects with CDAD received oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days. Subjects were followed up for 30 day after the last dose of vancomycin. Subjects who had a first recurrence of CDAD during the follow-up period were offered to enter a re-treatment extension period with cadazolid (10 days of cadazolid + 30-day follow up)
Overall Study Withdrawal by Subject	14	18
Overall Study Death	11	15
Overall Study Physician Decision	8	9
Overall Study Lost to Follow-up	4	8
Overall Study Sponsor Decision	1	1

Baseline Characteristics

Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cadazolid n=290 Participants Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days	Vancomycin n=301 Participants Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days	Total n=591 Participants Total of all reporting groups
Age, Customized 18-64 years	139 Participants n=5 Participants	152 Participants n=7 Participants	291 Participants n=5 Participants
Age, Customized 65-74 years	64 Participants n=5 Participants	60 Participants n=7 Participants	124 Participants n=5 Participants
Age, Customized 75 years and older	87 Participants n=5 Participants	89 Participants n=7 Participants	176 Participants n=5 Participants
Sex: Female, Male Female	187 Participants n=5 Participants	183 Participants n=7 Participants	370 Participants n=5 Participants
Sex: Female, Male Male	103 Participants n=5 Participants	118 Participants n=7 Participants	221 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Whtie	266 Participants n=5 Participants	271 Participants n=7 Participants	537 Participants n=5 Participants
Race/Ethnicity, Customized Other	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	102 Participants n=5 Participants	107 Participants n=7 Participants	209 Participants n=5 Participants
Region of Enrollment Canada	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment Europe	121 Participants n=5 Participants	124 Participants n=7 Participants	245 Participants n=5 Participants
Region of Enrollment Other	52 Participants n=5 Participants	54 Participants n=7 Participants	106 Participants n=5 Participants
CDAD episode type strata First occurrence	235 Participants n=5 Participants	246 Participants n=7 Participants	481 Participants n=5 Participants
CDAD episode type strata First recurrence	55 Participants n=5 Participants	55 Participants n=7 Participants	110 Participants n=5 Participants
Initial strain of Clostridium difficile Hypervirulent strains	75 Participants n=5 Participants	88 Participants n=7 Participants	163 Participants n=5 Participants
Initial strain of Clostridium difficile Non-hypervirulent strains	181 Participants n=5 Participants	183 Participants n=7 Participants	364 Participants n=5 Participants
Initial strain of Clostridium difficile Unable to determine	34 Participants n=5 Participants	30 Participants n=7 Participants	64 Participants n=5 Participants
CDAD severity at baseline Mild-Moderate	216 Participants n=5 Participants	227 Participants n=7 Participants	443 Participants n=5 Participants
CDAD severity at baseline Severe	54 Participants n=5 Participants	57 Participants n=7 Participants	111 Participants n=5 Participants
CDAD severity at baseline Unable to determine	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Day 12 on average (end-of-treatment + 2 days)

Population: Modified intent-to-treat population (mITT): all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD, and excluding 22 randomized subjects due to potential data integrity issues.

Outcome measures

Outcome measures
Measure	Cadazolid n=290 Participants Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days	Vancomycin n=301 Participants Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population	81 Percentage of participants Interval 76.1 to 85.1	85.7 Percentage of participants Interval 81.3 to 89.2

PRIMARY outcome

Timeframe: Up to Day 12 on average (end-of-treatment + 2 days)

Population: per-protocol population: all subjects from the mITT population without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.

Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant between first dose of study drug and 2 days after EOT. CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.

Outcome measures

Outcome measures
Measure	Cadazolid n=247 Participants Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days	Vancomycin n=259 Participants Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
Clinical Cure Rate (CCR) in the Per-protocol Population	86.6 Percentage of participants Interval 81.8 to 90.3	91.5 Percentage of participants Interval 87.5 to 94.3

SECONDARY outcome

Timeframe: Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)

Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The main analysis is performed on the modified intent-to-treat set (mITT).

Outcome measures

Outcome measures
Measure	Cadazolid n=290 Participants Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days	Vancomycin n=301 Participants Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population	63.4 Percentage of subjects Interval 57.8 to 68.8	61.8 Percentage of subjects Interval 56.2 to 67.1

SECONDARY outcome

Timeframe: Up to Day 10

Resolution of Diarrhea (ROD) is defined as no more than 3 unformed bowel movements per day for at least two consecutive days for subjects on study treatment. The Kaplan-Meier estimates (KM estimates) for having an event (ROD) are reported for each time point.

Outcome measures

Outcome measures
Measure	Cadazolid n=290 Participants Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days	Vancomycin n=301 Participants Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
Kaplan-Meier Estimates for Resolution of Diarrhea (ROD) Day 1	51.0 KM estimate (% subjects with ROD) Interval 45.4 to 56.9	45.8 KM estimate (% subjects with ROD) Interval 40.4 to 51.6
Kaplan-Meier Estimates for Resolution of Diarrhea (ROD) Day 2	64.5 KM estimate (% subjects with ROD) Interval 59.0 to 70.0	59.8 KM estimate (% subjects with ROD) Interval 54.3 to 65.4
Kaplan-Meier Estimates for Resolution of Diarrhea (ROD) Day 3	69.7 KM estimate (% subjects with ROD) Interval 64.3 to 74.8	67.8 KM estimate (% subjects with ROD) Interval 62.5 to 73.0
Kaplan-Meier Estimates for Resolution of Diarrhea (ROD) Day 4	73.8 KM estimate (% subjects with ROD) Interval 68.6 to 78.7	72.8 KM estimate (% subjects with ROD) Interval 67.6 to 77.7
Kaplan-Meier Estimates for Resolution of Diarrhea (ROD) Day 5	77.9 KM estimate (% subjects with ROD) Interval 73.0 to 82.5	78.4 KM estimate (% subjects with ROD) Interval 73.6 to 82.9
Kaplan-Meier Estimates for Resolution of Diarrhea (ROD) Day 6	77.9 KM estimate (% subjects with ROD) Interval 73.0 to 82.5	81.4 KM estimate (% subjects with ROD) Interval 76.8 to 85.6
Kaplan-Meier Estimates for Resolution of Diarrhea (ROD) Day 7	79.7 KM estimate (% subjects with ROD) Interval 74.8 to 84.1	83.7 KM estimate (% subjects with ROD) Interval 79.3 to 87.6
Kaplan-Meier Estimates for Resolution of Diarrhea (ROD) Day 8	81.0 KM estimate (% subjects with ROD) Interval 76.3 to 85.3	85.7 KM estimate (% subjects with ROD) Interval 81.5 to 89.4
Kaplan-Meier Estimates for Resolution of Diarrhea (ROD) Day 9	81.0 KM estimate (% subjects with ROD) Interval 76.3 to 85.3	85.7 KM estimate (% subjects with ROD) Interval 81.5 to 89.4
Kaplan-Meier Estimates for Resolution of Diarrhea (ROD) Day 10	81.0 KM estimate (% subjects with ROD) Interval 76.3 to 85.3	85.7 KM estimate (% subjects with ROD) Interval 81.5 to 89.4

SECONDARY outcome

Timeframe: Baseline to End of Treatment (10 days after starting study drug) + 2 days

Population: All subjects from the modified intent-to-treat population, excluding those who participated in the validation sub-study. No imputation of missing scores is performed prior to deriving response status. Subjects with missing values at baseline or at Day 3 are considered to be non-responders.

CDI-DaySyms PRO is a questionnaire assessing 10 symptoms relevant to subjects with CDAD and grouped into 3 domains: Diarrhea symptoms, Abdominal symptoms and Systemic/Other. The subjects rate the severity of each item as None, Mild, Moderate, Severe or Very severe, converted to numeric scores from 0 to 4, respectively. The daily domain score is calculated as the mean of the non-missing responses for that domain on that day. A negative value for change from baseline corresponds to an improvement in domain score. The three domains are evaluated in a hierarchical manner, starting with Diarrhea Symptoms, then Abdominal Symptoms, and finally Systemic/Other Symptoms.

Outcome measures

Outcome measures
Measure	Cadazolid n=232 Participants Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days	Vancomycin n=245 Participants Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores Diarrhea symptoms	-1.242 Scores on a scale Interval -1.4 to -1.09	-1.199 Scores on a scale Interval -1.35 to -1.05
Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores Abdominal symptoms	-0.669 Scores on a scale Interval -0.79 to -0.54	-0.693 Scores on a scale Interval -0.82 to -0.57
Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores Other symptoms	-0.67 Scores on a scale Interval -0.77 to -0.56	-0.731 Scores on a scale Interval -0.83 to -0.63

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)

Population: Modified intent-to-treat population: all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD, and excluding 22 randomized subjects due to potential data integrity issues.

ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below.

Outcome measures

Outcome measures
Measure	Cadazolid n=290 Participants Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days	Vancomycin n=301 Participants Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Modified Intent-to-treat Population	87.2 Percentage of participants Interval 82.9 to 90.6	88.4 Percentage of participants Interval 84.3 to 91.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)

Population: Per-protocol population: all subjects from the mITT analysis set without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.

ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. ICR rate (%) is the percentage of subjects with ICR assessed as cured. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.

Outcome measures

Outcome measures
Measure	Cadazolid n=247 Participants Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days	Vancomycin n=259 Participants Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Per-protocol Population	91.1 Percentage of participants Interval 86.9 to 94.0	92.7 Percentage of participants Interval 88.8 to 95.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Between Day 38 and Day 42 on average (end-of-treatment + 28 to 32 days)

ISR rate (%) is the percentage of subjects assessed as Sustained Cure at Visit 5, according to the investigator's own judgement. Sustained Cure is defined for each subject having Clinical Cure and no recurrence. Subjects with missing assessment are considered as having 'Not Sustained Cure' for the analysis. ISR rate is used as a supportive measure of the secondary efficacy endpoint (SCR). Analyses are performed on the modified intent-to-treat set (mITT).

Outcome measures

Outcome measures
Measure	Cadazolid n=290 Participants Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days	Vancomycin n=301 Participants Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
Investigator's Assessment of Sustained Response Rate (ISR Rate) at Visit 5	69.3 Percentage of participants Interval 63.8 to 74.3	60.5 Percentage of participants Interval 54.8 to 65.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)

Population: Per-protocol population: all subjects from the mITT population without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.

Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The analyses performed on the modified intent-to- treat set (mITT) are repeated on the per-protocol set (PPS) for sensitivity.

Outcome measures

Outcome measures
Measure	Cadazolid n=247 Participants Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days	Vancomycin n=259 Participants Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
Sustained Cure Rate (SCR) in the Per-protocol Population	67.6 Percentage of participants Interval 61.5 to 73.1	64.9 Percentage of participants Interval 58.9 to 70.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Between Day 13 and Day 40 on average (from end-of-treatment + 3 days and end-of-treatment + 30 days)

Population: Subjects from the modified intent-to-treat analysis set (mITT) with clinical cure

Recurrence is defined as the occurrence of a new episode of diarrhea (\> 3 unformed bowel movements on any day between end-of-treatment + 3 days and end-of-treatment + 30 days ) Recurrence rates is the percentage of subjects assessed as having a recurrence out of subjects with Clinical Cure.

Outcome measures

Outcome measures
Measure	Cadazolid n=235 Participants Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days	Vancomycin n=258 Participants Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
Recurrence Rate	15.7 Percentage of participants Interval 11.6 to 20.9	17.8 Percentage of participants Interval 13.6 to 23.0

Adverse Events

Cadazolid

Serious events: 35 serious events

Other events: 47 other events

Deaths: 11 deaths

Vancomycin

Serious events: 46 serious events

Other events: 51 other events

Deaths: 15 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Cadazolid n=294 participants at risk oral cadazolid 250 mg twice daily (bid) for 10 days	Vancomycin n=307 participants at risk oral vancomycin 125 mg 4 times per day (qid) for 10 days
Infections and infestations Clostridium difficile infection	3.4% 10/294 • Number of events 11 • Serious and frequent adverse events are reported from study treatment initiation up to Day 17 on average (i.e., 7 days after end-of-treatment or study withdrawal) and all-cause mortality up to Day 40 on average (i.e. 28 to 32 days after end-of-treatment or study withdrawal) 294 subjects who received at least one dose of cadazolid (cadazolid arm) and 307 subjects who received at least one dose of vancomycin (vancomycin arm) were included in the safety analysis. The median duration of treatment was 10 days in both arms.	5.5% 17/307 • Number of events 17 • Serious and frequent adverse events are reported from study treatment initiation up to Day 17 on average (i.e., 7 days after end-of-treatment or study withdrawal) and all-cause mortality up to Day 40 on average (i.e. 28 to 32 days after end-of-treatment or study withdrawal) 294 subjects who received at least one dose of cadazolid (cadazolid arm) and 307 subjects who received at least one dose of vancomycin (vancomycin arm) were included in the safety analysis. The median duration of treatment was 10 days in both arms.
Nervous system disorders Headache	4.4% 13/294 • Number of events 15 • Serious and frequent adverse events are reported from study treatment initiation up to Day 17 on average (i.e., 7 days after end-of-treatment or study withdrawal) and all-cause mortality up to Day 40 on average (i.e. 28 to 32 days after end-of-treatment or study withdrawal) 294 subjects who received at least one dose of cadazolid (cadazolid arm) and 307 subjects who received at least one dose of vancomycin (vancomycin arm) were included in the safety analysis. The median duration of treatment was 10 days in both arms.	5.9% 18/307 • Number of events 21 • Serious and frequent adverse events are reported from study treatment initiation up to Day 17 on average (i.e., 7 days after end-of-treatment or study withdrawal) and all-cause mortality up to Day 40 on average (i.e. 28 to 32 days after end-of-treatment or study withdrawal) 294 subjects who received at least one dose of cadazolid (cadazolid arm) and 307 subjects who received at least one dose of vancomycin (vancomycin arm) were included in the safety analysis. The median duration of treatment was 10 days in both arms.
Gastrointestinal disorders Nausea	5.4% 16/294 • Number of events 19 • Serious and frequent adverse events are reported from study treatment initiation up to Day 17 on average (i.e., 7 days after end-of-treatment or study withdrawal) and all-cause mortality up to Day 40 on average (i.e. 28 to 32 days after end-of-treatment or study withdrawal) 294 subjects who received at least one dose of cadazolid (cadazolid arm) and 307 subjects who received at least one dose of vancomycin (vancomycin arm) were included in the safety analysis. The median duration of treatment was 10 days in both arms.	3.6% 11/307 • Number of events 13 • Serious and frequent adverse events are reported from study treatment initiation up to Day 17 on average (i.e., 7 days after end-of-treatment or study withdrawal) and all-cause mortality up to Day 40 on average (i.e. 28 to 32 days after end-of-treatment or study withdrawal) 294 subjects who received at least one dose of cadazolid (cadazolid arm) and 307 subjects who received at least one dose of vancomycin (vancomycin arm) were included in the safety analysis. The median duration of treatment was 10 days in both arms.
General disorders Pyrexia	5.1% 15/294 • Number of events 20 • Serious and frequent adverse events are reported from study treatment initiation up to Day 17 on average (i.e., 7 days after end-of-treatment or study withdrawal) and all-cause mortality up to Day 40 on average (i.e. 28 to 32 days after end-of-treatment or study withdrawal) 294 subjects who received at least one dose of cadazolid (cadazolid arm) and 307 subjects who received at least one dose of vancomycin (vancomycin arm) were included in the safety analysis. The median duration of treatment was 10 days in both arms.	3.6% 11/307 • Number of events 12 • Serious and frequent adverse events are reported from study treatment initiation up to Day 17 on average (i.e., 7 days after end-of-treatment or study withdrawal) and all-cause mortality up to Day 40 on average (i.e. 28 to 32 days after end-of-treatment or study withdrawal) 294 subjects who received at least one dose of cadazolid (cadazolid arm) and 307 subjects who received at least one dose of vancomycin (vancomycin arm) were included in the safety analysis. The median duration of treatment was 10 days in both arms.

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