Trial Outcomes & Findings for Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea (NCT NCT01987895)
NCT ID: NCT01987895
Last Updated: 2025-02-04
Results Overview
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 modified intent-to-treat set (mITT) are reported below.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
632 participants
Primary outcome timeframe
Up to Day 12 on average (end-of-treatment + 2 days)
Results posted on
2025-02-04
Participant Flow
904 patients at 70 sites in 12 countries were screened, among whom 632 were enrolled in the IMPACT 1 trial at 64 sites located in North \& South America, Europe and Australia.
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 day 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 day of cadazolid + 30-day follow up)
|
|---|---|---|
|
Overall Study
STARTED
|
306
|
326
|
|
Overall Study
COMPLETED
|
276
|
296
|
|
Overall Study
NOT COMPLETED
|
30
|
30
|
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 day 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 day of cadazolid + 30-day follow up)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
7
|
|
Overall Study
Physician Decision
|
8
|
10
|
|
Overall Study
Death
|
7
|
7
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
randomized before giving IC
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea
Baseline characteristics by cohort
| Measure |
Cadazolid
n=302 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=318 Participants
Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
|
Total
n=620 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-64 years
|
180 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
383 Participants
n=5 Participants
|
|
Age, Customized
65-74 years
|
73 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Age, Customized
75 years and older
|
49 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
183 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
378 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
288 Participants
n=5 Participants
|
299 Participants
n=7 Participants
|
587 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
101 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
83 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
111 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Region of Enrollment
Other
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
CDAD episode type strata
First occurrence
|
238 Participants
n=5 Participants
|
253 Participants
n=7 Participants
|
491 Participants
n=5 Participants
|
|
CDAD episode type strata
First recurrence
|
64 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Initial strain of Clostridium difficile
Hypervirulent strains
|
58 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Initial strain of Clostridium difficile
Non-hypervirulent strains
|
226 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
441 Participants
n=5 Participants
|
|
Initial strain of Clostridium difficile
Unable to determine
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
CDAD severity at baseline
Mild-Moderate
|
227 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
470 Participants
n=5 Participants
|
|
CDAD severity at baseline
Severe
|
59 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
CDAD severity at baseline
Unable to determine
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 12 on average (end-of-treatment + 2 days)Population: All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD.
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 modified intent-to-treat set (mITT) are reported below.
Outcome measures
| Measure |
Cadazolid
n=302 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=318 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
|
83.8 Percentage of participants
Interval 79.2 to 87.5
|
85.2 Percentage of participants
Interval 80.9 to 88.7
|
PRIMARY outcome
Timeframe: Up to Day 12 on average (end-of-treatment + 2 days)Population: All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD and 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
| Measure |
Cadazolid
n=282 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=288 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
|
87.6 Percentage of participants
Interval 83.2 to 90.9
|
91.7 Percentage of participants
Interval 87.9 to 94.3
|
SECONDARY outcome
Timeframe: Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)Population: All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD.
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
| Measure |
Cadazolid
n=302 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=318 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
|
65.6 Percentage of participants
Interval 60.0 to 70.7
|
62.3 Percentage of participants
Interval 56.8 to 67.4
|
SECONDARY outcome
Timeframe: Up to Day 10Population: The analyses were performed on the modified intention-to-treat population: all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD
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
| Measure |
Cadazolid
n=302 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=318 Participants
Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
|
|---|---|---|
|
Kaplan-Meier Estimates for Resolution of Diarrhea
Day 1
|
46.7 KM estimate (%)
Interval 41.2 to 52.5
|
45.9 KM estimate (%)
Interval 40.6 to 51.6
|
|
Kaplan-Meier Estimates for Resolution of Diarrhea
Day 2
|
62.6 KM estimate (%)
Interval 57.2 to 68.0
|
60.7 KM estimate (%)
Interval 55.4 to 66.1
|
|
Kaplan-Meier Estimates for Resolution of Diarrhea
Day 3
|
69.9 KM estimate (%)
Interval 64.6 to 74.9
|
71.1 KM estimate (%)
Interval 66.0 to 76.0
|
|
Kaplan-Meier Estimates for Resolution of Diarrhea
Day 4
|
72.8 KM estimate (%)
Interval 67.7 to 77.7
|
77.7 KM estimate (%)
Interval 73.0 to 82.1
|
|
Kaplan-Meier Estimates for Resolution of Diarrhea
Day 5
|
77.8 KM estimate (%)
Interval 73.0 to 82.3
|
80.2 KM estimate (%)
Interval 75.6 to 84.4
|
|
Kaplan-Meier Estimates for Resolution of Diarrhea
Day 6
|
81.1 KM estimate (%)
Interval 76.5 to 85.3
|
81.8 KM estimate (%)
Interval 77.3 to 85.8
|
|
Kaplan-Meier Estimates for Resolution of Diarrhea
Day 7
|
82.5 KM estimate (%)
Interval 78.0 to 86.5
|
84.6 KM estimate (%)
Interval 80.4 to 88.3
|
|
Kaplan-Meier Estimates for Resolution of Diarrhea
Day 8
|
83.4 KM estimate (%)
Interval 79.0 to 87.4
|
85.2 KM estimate (%)
Interval 81.1 to 88.9
|
|
Kaplan-Meier Estimates for Resolution of Diarrhea
Day 9
|
83.8 KM estimate (%)
Interval 79.4 to 87.7
|
85.2 KM estimate (%)
Interval 81.1 to 88.9
|
|
Kaplan-Meier Estimates for Resolution of Diarrhea
Day 10
|
83.8 KM estimate (%)
Interval 79.4 to 87.7
|
85.2 KM estimate (%)
Interval 81.1 to 88.9
|
SECONDARY outcome
Timeframe: Day 1 (baseline) and Day 3Population: 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. The least squares means (LSM) are computed on the scores.
Outcome measures
| Measure |
Cadazolid
n=246 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=260 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
|
-1.233 Score on a scale
Interval -1.37 to -1.09
|
-1.235 Score on a scale
Interval -1.37 to -1.1
|
|
Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores
Abdominal symptoms
|
-0.623 Score on a scale
Interval -0.74 to -0.51
|
-0.710 Score on a scale
Interval -0.82 to -0.6
|
|
Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores
Other symptoms
|
-0.639 Score on a scale
Interval -0.74 to -0.54
|
-0.689 Score on a scale
Interval -0.79 to -0.59
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)Population: All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD.
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
| Measure |
Cadazolid
n=302 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=318 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
|
89.7 Percentage of participants
Interval 85.8 to 92.7
|
91.5 Percentage of participants
Interval 87.9 to 94.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)Population: All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD and 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
| Measure |
Cadazolid
n=282 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=288 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
|
92.2 Percentage of participants
Interval 88.5 to 94.8
|
94.1 Percentage of participants
Interval 90.8 to 96.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Between Day 38 and Day 42 on average (end-of-treatment + 28 to 32 days)Population: All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD.
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
| Measure |
Cadazolid
n=302 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=318 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
|
73.8 Percentage of participants
Interval 68.6 to 78.5
|
70.1 Percentage of participants
Interval 64.9 to 74.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)Population: All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD and 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
| Measure |
Cadazolid
n=282 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=288 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
|
68.8 Percentage of participants
Interval 63.2 to 73.9
|
67.7 Percentage of participants
Interval 62.1 to 72.8
|
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 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
| Measure |
Cadazolid
n=253 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=271 Participants
Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
|
|---|---|---|
|
Recurrence Rate
|
15 percentage of participants
Interval 11.1 to 19.9
|
21.4 percentage of participants
Interval 16.9 to 26.7
|
Adverse Events
Cadazolid
Serious events: 19 serious events
Other events: 33 other events
Deaths: 7 deaths
Vancomycin
Serious events: 26 serious events
Other events: 49 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Cadazolid
n=304 participants at risk
304 subjects received at least one dose of cadazolid and were included in the safety analysis. The median duration of treatment with cadazolid was 10 days.
|
Vancomycin
n=322 participants at risk
322 subjects received at least one dose of vancomycin and were included in the safety analysis. The median duration of treatment with vancomycin was 10 days.
|
|---|---|---|
|
Infections and infestations
Abdominal abscess
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Acute chest syndrome
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Gastrointestinal disorders
Ascites
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Injury, poisoning and procedural complications
Biliary anastomosis complication
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Cardiac disorders
Cardiac failure chronic
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.33%
1/304 • Number of events 1 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Hepatobiliary disorders
Cholangitis
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Infections and infestations
Clostridium difficile infection
|
0.66%
2/304 • Number of events 2 • 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)
|
2.5%
8/322 • Number of events 8 • 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)
|
|
Vascular disorders
Deep vein thrombosis
|
0.66%
2/304 • Number of events 2 • 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)
|
0.00%
0/322 • 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)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Infections and infestations
Endocarditis
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Vascular disorders
Hypotension
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Gastrointestinal disorders
Megacolon
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
General disorders
Oedema peripheral
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Infections and infestations
Peritonitis bacterial
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Infections and infestations
Pseudomembranous colitis
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Gastrointestinal disorders
Rectal stenosis
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Renal and urinary disorders
Renal failure
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.33%
1/304 • Number of events 1 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Infections and infestations
Sepsis
|
0.66%
2/304 • Number of events 2 • 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)
|
0.62%
2/322 • Number of events 2 • 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)
|
|
Infections and infestations
Septic shock
|
0.33%
1/304 • Number of events 1 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Infections and infestations
Sinusitis
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.33%
1/304 • Number of events 1 • 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)
|
0.00%
0/322 • 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)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/304 • 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)
|
0.31%
1/322 • Number of events 1 • 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)
|
Other adverse events
| Measure |
Cadazolid
n=304 participants at risk
304 subjects received at least one dose of cadazolid and were included in the safety analysis. The median duration of treatment with cadazolid was 10 days.
|
Vancomycin
n=322 participants at risk
322 subjects received at least one dose of vancomycin and were included in the safety analysis. The median duration of treatment with vancomycin was 10 days.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.6%
14/304 • Number of events 16 • 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)
|
6.8%
22/322 • Number of events 24 • 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)
|
|
Nervous system disorders
Headache
|
4.6%
14/304 • 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)
|
7.8%
25/322 • Number of events 28 • 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)
|
|
Gastrointestinal disorders
Nausea
|
3.9%
12/304 • 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)
|
7.5%
24/322 • Number of events 27 • 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)
|
Additional Information
Clinical Trial disclosure Desk
Actelion Pharmaceuticals Ltd
Phone: 0041615656565
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any study-related publication written independently by investigators must be submitted to Actelion for review at least 30 days prior to submission for publication or presentation. Upon review, Actelion may provide comments, and may also request alterations and/or deletions for the sole purpose of protecting its confidential information and/or patent rights.
- Publication restrictions are in place
Restriction type: OTHER