Trial Outcomes & Findings for PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region (NCT NCT00986102)
NCT ID: NCT00986102
Last Updated: 2024-11-19
Results Overview
Early onset of Nosocomial Pneumonia (NP) and Ventilator-Associated Pneumonia (VAP) is defined as less than 5 days after hospitalization and late onset of NP and VAP is defined as more than or equal to 5 days after hospitalization
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
216 participants
Primary outcome timeframe
5 to 14 days
Results posted on
2024-11-19
Participant Flow
217 patients were enrolled at sites in Malaysia, Indonesia, Singapore, Vietnam and Hong Kong.
217 patients were enrolled and 216 received study medication. 1 patient was enrolled but subsequently withdrew consent before receiving the study medication. 61 patients discontinued study medication prior to end of treatment.
Participant milestones
| Measure |
Nosocomial Pneumonia (NP)
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Ventilator-Associated Pneumonia (VAP)
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Complicated Urinary Tract Infection (cUTI)
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
|
Complicated Intra-abdominal Infection (cIAI)
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
53
|
77
|
19
|
67
|
|
Overall Study
COMPLETED
|
52
|
75
|
19
|
66
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
Nosocomial Pneumonia (NP)
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Ventilator-Associated Pneumonia (VAP)
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Complicated Urinary Tract Infection (cUTI)
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
|
Complicated Intra-abdominal Infection (cIAI)
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
Baseline Characteristics
PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region
Baseline characteristics by cohort
| Measure |
Nosocomial Pneumonia (NP)
n=53 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Ventilator-Associated Pneumonia (VAP)
n=77 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Complicated Urinary Tract Infection (cUTI)
n=19 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
|
Complicated Intra-abdominal Infection (cIAI)
n=67 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 17.52 • n=99 Participants
|
44.4 years
STANDARD_DEVIATION 19.17 • n=107 Participants
|
58.2 years
STANDARD_DEVIATION 13.23 • n=206 Participants
|
49.2 years
STANDARD_DEVIATION 16.13 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 17.88 • n=31 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
72 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
144 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
8 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Malay
|
33 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
120 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Indian
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Aboriginal
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Others
|
10 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Patient's location in the hospital upon enrollment
Intensive Care Unit (ICU)
|
30 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
137 Participants
n=31 Participants
|
|
Patient's location in the hospital upon enrollment
Non -ICU
|
23 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
77 Participants
n=31 Participants
|
|
Patient's location in the hospital upon enrollment
Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 5 to 14 daysPopulation: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
Early onset of Nosocomial Pneumonia (NP) and Ventilator-Associated Pneumonia (VAP) is defined as less than 5 days after hospitalization and late onset of NP and VAP is defined as more than or equal to 5 days after hospitalization
Outcome measures
| Measure |
Nosocomial Pneumonia (NP)
n=53 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Ventilator-Associated Pneumonia (VAP)
n=77 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Complicated Urinary Tract Infection (cUTI)
n=19 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
|
Complicated Intra-abdominal Infection (cIAI)
n=67 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
|
|---|---|---|---|---|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Early onset of VAP
|
0 Participants
|
32 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Late onset of VAP
|
0 Participants
|
45 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Gastric Ulcer Perforation
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Early onset of NP
|
23 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Late onset of NP
|
30 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Acute Pyelonephritis
|
0 Participants
|
0 Participants
|
11 Participants
|
0 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Emphysematous Pyelonephritis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Prostate Infection
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Pyelonephritis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Pyonephrosis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Urosepsis
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Complicated lower urinary tract infection
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Abdominal Abscess
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Appendiceal Abscess
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Appendicitis
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Appendicitis Perforated
|
0 Participants
|
0 Participants
|
0 Participants
|
24 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Cholecystitis Acute
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Diverticular Perforation
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Duodenal Ulcer Perforation
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Gallbladder Empyema
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Gastric Perforation
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Gastrointestinal Anastomotic Leak
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Gastrointestinal Stoma Complication
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Ileal Perforation
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Intestinal Perforation
|
0 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Large Intestine Perforation
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Pelvic Abscess
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Peritonitis
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Post Procedural Bile Leak
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Small Intestinal Perforation
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Small Intestine Gangrene
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 5 to 14 daysPopulation: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
Outcome measures
| Measure |
Nosocomial Pneumonia (NP)
n=53 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Ventilator-Associated Pneumonia (VAP)
n=77 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Complicated Urinary Tract Infection (cUTI)
n=19 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
|
Complicated Intra-abdominal Infection (cIAI)
n=67 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
|
|---|---|---|---|---|
|
Number of Participants With Different Mode of Usage of Doripenem
First Line Therapy
|
16 Participants
|
33 Participants
|
3 Participants
|
30 Participants
|
|
Number of Participants With Different Mode of Usage of Doripenem
Monotherapy
|
41 Participants
|
66 Participants
|
18 Participants
|
62 Participants
|
|
Number of Participants With Different Mode of Usage of Doripenem
Combination Therapy
|
12 Participants
|
11 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Different Mode of Usage of Doripenem
Second Line Therapy
|
37 Participants
|
44 Participants
|
16 Participants
|
37 Participants
|
PRIMARY outcome
Timeframe: 5 to 14 daysPopulation: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
Duration of doripenem and duration of doripenem plus oral antibiotics therapy
Outcome measures
| Measure |
Nosocomial Pneumonia (NP)
n=53 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Ventilator-Associated Pneumonia (VAP)
n=77 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Complicated Urinary Tract Infection (cUTI)
n=19 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
|
Complicated Intra-abdominal Infection (cIAI)
n=67 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
|
|---|---|---|---|---|
|
Duration of Antibiotic Therapy
Duration of doripenem therapy
|
7.4 Days
Standard Deviation 3.51
|
9.2 Days
Standard Deviation 4.67
|
6.9 Days
Standard Deviation 2.46
|
6.9 Days
Standard Deviation 2.86
|
|
Duration of Antibiotic Therapy
Duration of doripenem plus oral antibiotic therapy
|
7.5 Days
Standard Deviation 3.57
|
9.9 Days
Standard Deviation 6.07
|
9.1 Days
Standard Deviation 3.94
|
8.3 Days
Standard Deviation 4.50
|
PRIMARY outcome
Timeframe: Baseline (Day -1)Population: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
APACHE II is a severity of disease classification system and the score will be determined in the participants admitted to the Intensive Care Unit upon study enrollment to help predict the risk of mortality for critically ill patients. It consists of, A: acute physiology score (APS; range, 0 to 4), B: age points (range, 0 \[less than or equal to 44\] to 6 \[greater than or equal to 75\]) and C: chronic health points (2 \[elective postoperative patient\] and 5 \[non-operative or emergency postoperative patient\]). Total APACHE II score is sum of A, B and C.
Outcome measures
| Measure |
Nosocomial Pneumonia (NP)
n=53 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Ventilator-Associated Pneumonia (VAP)
n=77 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Complicated Urinary Tract Infection (cUTI)
n=19 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
|
Complicated Intra-abdominal Infection (cIAI)
n=67 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
|
|---|---|---|---|---|
|
Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
APACHE II score: less than or equal to 14
|
34 Participants
|
50 Participants
|
11 Participants
|
58 Participants
|
|
Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
APACHE II score: 15 to 19
|
8 Participants
|
15 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
APACHE II score: 20 to 24
|
4 Participants
|
7 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
APACHE II score: 25 to 29
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
APACHE II score: greater than or equal to 30
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
Missing
|
4 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 5 or Day 7 or Day 14Population: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
Outcome measures
| Measure |
Nosocomial Pneumonia (NP)
n=53 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Ventilator-Associated Pneumonia (VAP)
n=77 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Complicated Urinary Tract Infection (cUTI)
n=19 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
|
Complicated Intra-abdominal Infection (cIAI)
n=67 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
|
|---|---|---|---|---|
|
Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)
Clinical cure
|
33 Participants
|
49 Participants
|
15 Participants
|
46 Participants
|
|
Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)
Clinical failure
|
7 Participants
|
7 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)
Indeterminate outcome
|
5 Participants
|
15 Participants
|
1 Participants
|
10 Participants
|
|
Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)
Missing data
|
8 Participants
|
6 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: End-of-treatment (Day 5 or Day 7 or Day 14) plus 7 to 14 daysPopulation: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
Outcome measures
| Measure |
Nosocomial Pneumonia (NP)
n=53 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Ventilator-Associated Pneumonia (VAP)
n=77 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Complicated Urinary Tract Infection (cUTI)
n=19 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
|
Complicated Intra-abdominal Infection (cIAI)
n=67 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
|
|---|---|---|---|---|
|
Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit
Clinical failure
|
1 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit
Clinical cure
|
25 Participants
|
39 Participants
|
12 Participants
|
46 Participants
|
|
Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit
Relapse
|
1 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit
Indeterminate outcome
|
4 Participants
|
8 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit
Missing data
|
22 Participants
|
20 Participants
|
3 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 5 or Day 7 or Day 14Population: Microbiological Modified Intent-to-Treat Population (mMITT): included participants who had a baseline pathogen identified, regardless of susceptibility to study medication.
Outcome measures
| Measure |
Nosocomial Pneumonia (NP)
n=26 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Ventilator-Associated Pneumonia (VAP)
n=63 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Complicated Urinary Tract Infection (cUTI)
n=10 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
|
Complicated Intra-abdominal Infection (cIAI)
n=42 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
|
|---|---|---|---|---|
|
Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit
Persistence
|
0 Participants
|
14 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit
Eradication
|
7 Participants
|
12 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit
Presumed eradication
|
10 Participants
|
18 Participants
|
4 Participants
|
18 Participants
|
|
Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit
Presumed persistence
|
3 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit
Indeterminate
|
3 Participants
|
10 Participants
|
2 Participants
|
9 Participants
|
|
Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit
Missing data
|
3 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day -1) upto the duration of hospital stay of a participantPopulation: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
Medical resource utilization included length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation and time to discharge.
Outcome measures
| Measure |
Nosocomial Pneumonia (NP)
n=53 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Ventilator-Associated Pneumonia (VAP)
n=77 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Complicated Urinary Tract Infection (cUTI)
n=19 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
|
Complicated Intra-abdominal Infection (cIAI)
n=67 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
|
|---|---|---|---|---|
|
Medical Resource Utilization
Time to Discharge
|
13 Days
Full Range 15.23 • Interval 1.0 to 63.0
|
19 Days
Full Range 18.96 • Interval 1.0 to 97.0
|
8 Days
Full Range 7.72 • Interval 3.0 to 35.0
|
9 Days
Full Range 16.42 • Interval 2.0 to 88.0
|
|
Medical Resource Utilization
Length of hospital stay
|
21 Days
Full Range 25.89 • Interval 3.0 to 138.0
|
33 Days
Full Range 26.95 • Interval 5.0 to 132.0
|
13 Days
Full Range 12.19 • Interval 7.0 to 53.0
|
12 Days
Full Range 17.60 • Interval 5.0 to 80.0
|
|
Medical Resource Utilization
Length of Intensive Care Unit (ICU) Stay
|
8 Days
Full Range 14.40 • Interval 2.0 to 54.0
|
17 Days
Full Range 16.34 • Interval 3.0 to 66.0
|
4 Days
Full Range 9.76 • Interval 2.0 to 27.0
|
7 Days
Full Range 10.21 • Interval 1.0 to 52.0
|
|
Medical Resource Utilization
Duration of Mechanical Ventilation
|
6 Days
Full Range 11.88 • Interval 1.0 to 46.0
|
15 Days
Full Range 21.61 • Interval 3.0 to 115.0
|
2 Days
Full Range 1.92 • Interval 1.0 to 6.0
|
4 Days
Full Range 9.30 • Interval 1.0 to 44.0
|
SECONDARY outcome
Timeframe: Within 28 days after EOT (Day 5 or Day 7 or Day 14)Population: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
Outcome measures
| Measure |
Nosocomial Pneumonia (NP)
n=8 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Ventilator-Associated Pneumonia (VAP)
n=19 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Complicated Urinary Tract Infection (cUTI)
n=1 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
|
Complicated Intra-abdominal Infection (cIAI)
n=6 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
|
|---|---|---|---|---|
|
Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT)
Participant still in hospital
|
8 Participants
|
19 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT)
Participant readmitted in ICU
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 28 days after EOT (Day 5 or Day 7 or Day 14)Population: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
Outcome measures
| Measure |
Nosocomial Pneumonia (NP)
n=30 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Ventilator-Associated Pneumonia (VAP)
n=44 Participants
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Complicated Urinary Tract Infection (cUTI)
n=18 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
|
Complicated Intra-abdominal Infection (cIAI)
n=54 Participants
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
|
|---|---|---|---|---|
|
Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT)
Participants discharged from hospital
|
30 Participants
|
44 Participants
|
18 Participants
|
54 Participants
|
|
Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT)
Participants readmitted to hospital
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Nosocomial Pneumonia (NP)
Serious events: 22 serious events
Other events: 27 other events
Deaths: 0 deaths
Ventilator-Associated Pneumonia (VAP)
Serious events: 24 serious events
Other events: 38 other events
Deaths: 0 deaths
Complicated Urinary Tract Infection (cUTI)
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Complicated Intra-abdominal Infection (cIAI)
Serious events: 15 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nosocomial Pneumonia (NP)
n=53 participants at risk
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Ventilator-Associated Pneumonia (VAP)
n=77 participants at risk
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Complicated Urinary Tract Infection (cUTI)
n=19 participants at risk
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
|
Complicated Intra-abdominal Infection (cIAI)
n=67 participants at risk
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
3.0%
2/67 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
2.6%
2/77 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
2.6%
2/77 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Cardiac disorders
Cardiac Arrest
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Cardiac disorders
Mitral Valve Stenosis
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Cardiac disorders
Right Ventricular Failure
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Gastrointestinal disorders
Gastric Ulcer Perforation
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Gastrointestinal disorders
Gastrointestinal Perforation
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Gastrointestinal disorders
Melaena
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
General disorders
Death
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Abdominal Wall Abscess
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Brain Abscess
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Pneumonia
|
9.4%
5/53 • Number of events 5 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.2%
4/77 • Number of events 5 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
6.0%
4/67 • Number of events 4 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Sepsis
|
3.8%
2/53 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
3.9%
3/77 • Number of events 3 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
7.5%
5/67 • Number of events 5 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Septic Shock
|
11.3%
6/53 • Number of events 6 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.2%
4/77 • Number of events 4 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Urinary Tract Infection
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Wound Infection Fungal
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Injury, poisoning and procedural complications
Endotracheal Intubation Complication
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Injury, poisoning and procedural complications
Operative Haemorrhage
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Injury, poisoning and procedural complications
Procedural Hypotension
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Injury, poisoning and procedural complications
Tracheostomy Malfunction
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Injury, poisoning and procedural complications
Traumatic Brain Injury
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Oxygen Saturation Decreased
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
2.6%
2/77 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Nervous system disorders
Convulsion
|
3.8%
2/53 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Nervous system disorders
Headache
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Psychiatric disorders
Post-Traumatic Amnestic Disorder
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
2.6%
2/77 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Renal and urinary disorders
Renal Failure
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Renal and urinary disorders
Renal Failure Acute
|
3.8%
2/53 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Respiratory, thoracic and mediastinal disorders
Dependence On Respirator
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Oedema
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
3.8%
2/53 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.8%
2/53 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
2.6%
2/77 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous Emphysema
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Vascular disorders
Haemodynamic Instability
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
Other adverse events
| Measure |
Nosocomial Pneumonia (NP)
n=53 participants at risk
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Ventilator-Associated Pneumonia (VAP)
n=77 participants at risk
500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
|
Complicated Urinary Tract Infection (cUTI)
n=19 participants at risk
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
|
Complicated Intra-abdominal Infection (cIAI)
n=67 participants at risk
500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.7%
3/53 • Number of events 4 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.2%
4/77 • Number of events 5 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
4.5%
3/67 • Number of events 3 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.2%
4/77 • Number of events 4 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
2.6%
2/77 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Cardiac disorders
Bradycardia
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Cardiac disorders
Left Ventricular Failure
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Cardiac disorders
Tachycardia
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
2.6%
2/77 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
3.0%
2/67 • Number of events 3 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Gastrointestinal disorders
Duodenitis
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Gastrointestinal disorders
Haematemesis
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Gastrointestinal disorders
Parotid Gland Enlargement
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
3/53 • Number of events 3 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Acinetobacter Infection
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
2.6%
2/77 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Candiduria
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Cellulitis
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Herpes Dermatitis
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Liver Abscess
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Nosocomial Infection
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
3.9%
3/77 • Number of events 4 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Peritoneal Tuberculosis
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Pneumonia
|
1.9%
1/53 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.2%
4/77 • Number of events 5 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
10.5%
2/19 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Sepsis
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Soft Tissue Infection
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
3.9%
3/77 • Number of events 3 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Stenotrophomonas Sepsis
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Urinary Tract Infection
|
3.8%
2/53 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
2.6%
2/77 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
7.5%
5/67 • Number of events 5 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Alanine Aminotransferase Increased
|
7.5%
4/53 • Number of events 4 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
3.9%
3/77 • Number of events 3 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.7%
3/53 • Number of events 3 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Bilirubin Conjugated Increased
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
9.4%
5/53 • Number of events 5 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
2.6%
2/77 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Blood Bicarbonate Increased
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Blood Bilirubin Unconjugated Increased
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Blood Cortisol Decreased
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
2.6%
2/77 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
3.0%
2/67 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Blood Triglycerides Increased
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Coagulation Time Prolonged
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Creatinine Renal Clearance Decreased
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Gamma-Glutamyltransferase Abnormal
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
9.4%
5/53 • Number of events 5 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Glomerular Filtration Rate Decreased
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Haematocrit Increased
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Haemoglobin Increased
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Oxygen Saturation Decreased
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Red Blood Cell Count Decreased
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
Transaminases Increased
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
White Blood Cell Count Decreased
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Investigations
White Blood Cell Count Increased
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
2.6%
2/77 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
3.0%
2/67 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.7%
3/53 • Number of events 3 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.5%
4/53 • Number of events 5 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
2.6%
2/77 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
5.3%
1/19 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Metabolism and nutrition disorders
Metabolic Alkalosis
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
7.5%
4/53 • Number of events 4 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
6.5%
5/77 • Number of events 5 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
3.0%
2/67 • Number of events 2 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous Emphysema
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Vascular disorders
Hypertension
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
7.5%
5/67 • Number of events 5 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Vascular disorders
Hypotension
|
1.9%
1/53 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/77 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Vascular disorders
Thrombophlebitis
|
5.7%
3/53 • Number of events 4 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
21.1%
4/19 • Number of events 6 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.5%
1/67 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
|
Vascular disorders
Withdrawal Hypertension
|
0.00%
0/53 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
1.3%
1/77 • Number of events 1 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/19 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
0.00%
0/67 • From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton.
|
Additional Information
VP MEDICAL AFFAIRS ASIA PACIFIC
Jan-Cil Singapore
Phone: +65 6827 6753
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60