Trial Outcomes & Findings for Evaluation of Safety, PK and Immunomodulatory Effects of AB103 in Necrotizing Soft Tissue Infections Patients (NCT NCT01417780)
NCT ID: NCT01417780
Last Updated: 2021-08-18
Results Overview
An AE is any untoward medical occurrence in a subject administered study drug and that does not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
7 days
Results posted on
2021-08-18
Participant Flow
This study was conducted by qualified investigators under the sponsorship of Atox Bio Ltd. at 7 trauma centers, of which 6 enrolled patients from December 2011 through August 2012.
Of 43 randomized patients who received AB103 or placebo (intent-to-treat \[ITT\] population; safety analyses), 3 patients were excluded to form the modified intent-to-treat (mITT) population before unblinding due to protocol violations. Therefore, a total of 40 patients were included in the mITT efficacy analyses. With respect to any variable, the number of patients analyzed is the number of patients with non-missing data within the respective population.
Participant milestones
| Measure |
AB103 0.25 mg/kg
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
17
|
11
|
|
Overall Study
COMPLETED
|
14
|
14
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Safety, PK and Immunomodulatory Effects of AB103 in Necrotizing Soft Tissue Infections Patients
Baseline characteristics by cohort
| Measure |
AB103 0.25 mg/kg
n=15 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=15 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=10 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 13.6 • n=39 Participants
|
50.1 years
STANDARD_DEVIATION 15.2 • n=41 Participants
|
52.5 years
STANDARD_DEVIATION 20.4 • n=35 Participants
|
50.9 years
STANDARD_DEVIATION 15.2 • n=31 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
14 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
26 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
36 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
35 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
NSTI Diagnosis
Fournier Gangrene
|
5 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
13 Participants
n=31 Participants
|
|
NSTI Diagnosis
Other NSTI
|
10 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
27 Participants
n=31 Participants
|
|
Body Mass Index (BMI)
|
31.0 kg/m2
STANDARD_DEVIATION 6.5 • n=39 Participants
|
31.7 kg/m2
STANDARD_DEVIATION 9.7 • n=41 Participants
|
29.9 kg/m2
STANDARD_DEVIATION 9.3 • n=35 Participants
|
31.5 kg/m2
STANDARD_DEVIATION 8.2 • n=31 Participants
|
|
Acute Physiology And Chronic Health Evaluation II (APACHE II) Score
|
7.5 units on a scale
STANDARD_DEVIATION 5.0 • n=39 Participants
|
8.3 units on a scale
STANDARD_DEVIATION 4.5 • n=41 Participants
|
9.6 units on a scale
STANDARD_DEVIATION 4.7 • n=35 Participants
|
8.3 units on a scale
STANDARD_DEVIATION 4.7 • n=31 Participants
|
|
Sequential Organ Failure Assessment (SOFA) Score
|
2.87 units on a scale
STANDARD_DEVIATION 2.70 • n=39 Participants
|
3.47 units on a scale
STANDARD_DEVIATION 2.53 • n=41 Participants
|
3.10 units on a scale
STANDARD_DEVIATION 1.97 • n=35 Participants
|
3.15 units on a scale
STANDARD_DEVIATION 2.42 • n=31 Participants
|
|
Cardiovascular Organ Failure
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population.
An AE is any untoward medical occurrence in a subject administered study drug and that does not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug.
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=15 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=17 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=11 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Number of Subjects With One or More Adverse Events (AEs) During the Treatment Period
|
14 Participants
|
16 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population.
A serious adverse event (SAE) is an AE occurring during any study phase and at any dose of the study drug (AB103 or placebo) that fulfills one or more of the following criteria: * Results in death * Is life-threatening (i.e., the subject was, in the opinion of the Investigator, at immediate risk of death from the event as it occurred) * Requires or prolongs hospitalization * Results in persistent or significant disability or incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions) * Is a congenital anomaly or birth defect, or * Is an important and significant medical event.
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=15 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=17 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=11 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Number of Subjects With One or More Serious Adverse Events (SAEs)
|
8 Participants
|
5 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Screening and Day 7Population: The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population.
Screening ALT results, Day 7 ALT results, and change in ALT from screening to Day 7
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=12 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=15 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=10 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Alanine Aminotransferase (ALT)
Screening
|
55.9 units/L
Standard Deviation 99.8
|
28.1 units/L
Standard Deviation 17.3
|
46.8 units/L
Standard Deviation 57.2
|
|
Alanine Aminotransferase (ALT)
Day 7
|
27.9 units/L
Standard Deviation 18.8
|
27.3 units/L
Standard Deviation 26.3
|
26.0 units/L
Standard Deviation 13.2
|
|
Alanine Aminotransferase (ALT)
Change from Screening to Day 7
|
-23.2 units/L
Standard Deviation 95.1
|
-0.8 units/L
Standard Deviation 31.2
|
-19.8 units/L
Standard Deviation 60.5
|
PRIMARY outcome
Timeframe: Screening and Day 7Population: The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population.
Screening AST results, Day 7 AST results, and change in AST from screening to Day 7
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=14 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=17 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=11 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Aspartate Aminotransferase (AST)
Screening
|
35.8 units/L
Standard Deviation 30.6
|
37.4 units/L
Standard Deviation 28.3
|
32.0 units/L
Standard Deviation 19.2
|
|
Aspartate Aminotransferase (AST)
Day 7
|
30.6 units/L
Standard Deviation 17.1
|
24.3 units/L
Standard Deviation 10.1
|
27.4 units/L
Standard Deviation 9.7
|
|
Aspartate Aminotransferase (AST)
Change from Screening to Day 7
|
-1.2 units/L
Standard Deviation 30.7
|
-9.3 units/L
Standard Deviation 21.7
|
0.1 units/L
Standard Deviation 9.6
|
PRIMARY outcome
Timeframe: Screening and Day 7Population: The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population.
Screening ALP results, Day 7 ALP results, and change in ALP from screening to Day 7
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=14 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=17 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=11 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Alkaline Phosphatase (ALP)
Screening
|
97.5 units/L
Standard Deviation 53.5
|
104.3 units/L
Standard Deviation 47.7
|
108.3 units/L
Standard Deviation 44.2
|
|
Alkaline Phosphatase (ALP)
Day 7
|
93.1 units/L
Standard Deviation 45.2
|
84.8 units/L
Standard Deviation 33.9
|
100.6 units/L
Standard Deviation 65.9
|
|
Alkaline Phosphatase (ALP)
Change from Screening to Day 7
|
5.2 units/L
Standard Deviation 40.1
|
-10.6 units/L
Standard Deviation 62.3
|
-11.4 units/L
Standard Deviation 34.6
|
PRIMARY outcome
Timeframe: Screening and Day 7Population: The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population.
Screening Tbili results, Day 7 Tbili results, and change in Tbili from screening to Day 7
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=14 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=17 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=10 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Total Bilirubin (Tbili)
Day 7
|
0.6 mg/dL
Standard Deviation 0.2
|
0.6 mg/dL
Standard Deviation 0.3
|
1.1 mg/dL
Standard Deviation 0.8
|
|
Total Bilirubin (Tbili)
Screening
|
1.2 mg/dL
Standard Deviation 0.7
|
1.2 mg/dL
Standard Deviation 0.8
|
1.5 mg/dL
Standard Deviation 1.7
|
|
Total Bilirubin (Tbili)
Change from Screening to Day 7
|
-0.8 mg/dL
Standard Deviation 0.6
|
-0.5 mg/dL
Standard Deviation 0.5
|
-0.4 mg/dL
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Screening and Day 7Population: The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population.
Screening sCr results, Day 7 sCr results, and change in sCr from screening to Day 7
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=15 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=17 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=11 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Serum Creatinine (sCr)
Screening
|
1.2 mg/dL
Standard Deviation 0.5
|
1.2 mg/dL
Standard Deviation 1.0
|
1.2 mg/dL
Standard Deviation 0.7
|
|
Serum Creatinine (sCr)
Day 7
|
1.1 mg/dL
Standard Deviation 0.9
|
1.3 mg/dL
Standard Deviation 1.7
|
1.0 mg/dL
Standard Deviation 0.4
|
|
Serum Creatinine (sCr)
Change from Screening to Day 7
|
-0.1 mg/dL
Standard Deviation 0.7
|
0.1 mg/dL
Standard Deviation 2.0
|
-0.2 mg/dL
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Screening and Day 7Population: The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population.
Screening Alb results, Day 7 Alb results, and change in Alb from screening to Day 7
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=12 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=15 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=9 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Albumin (Alb)
Screening
|
2.5 g/dL
Standard Deviation 0.9
|
2.1 g/dL
Standard Deviation 0.5
|
2.3 g/dL
Standard Deviation 0.5
|
|
Albumin (Alb)
Day 7
|
1.9 g/dL
Standard Deviation 0.9
|
1.7 g/dL
Standard Deviation 0.4
|
2.3 g/dL
Standard Deviation 0.6
|
|
Albumin (Alb)
Change from Screening to Day 7
|
-0.6 g/dL
Standard Deviation 0.4
|
-0.3 g/dL
Standard Deviation 0.2
|
0.1 g/dL
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Screening and Day 7Population: The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population.
Screening Hgb results, Day 7 Hgb results, and change in Hgb from screening to Day 7
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=15 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=17 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=11 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Hemoglobin (Hgb)
Screening
|
11.5 g/dL
Standard Deviation 2.2
|
11.0 g/dL
Standard Deviation 1.5
|
10.5 g/dL
Standard Deviation 2.6
|
|
Hemoglobin (Hgb)
Day 7
|
8.8 g/dL
Standard Deviation 2.1
|
8.9 g/dL
Standard Deviation 1.1
|
9.0 g/dL
Standard Deviation 1.4
|
|
Hemoglobin (Hgb)
Change from Screening to Day 7
|
-2.9 g/dL
Standard Deviation 2.1
|
-2.5 g/dL
Standard Deviation 1.5
|
-1.3 g/dL
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Screening and Day 7Population: The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population.
Screening WBC results, Day 7 WBC results, and change in WBC from screening to Day 7
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=15 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=17 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=11 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Total White Blood Cell (WBC) Count
Screening
|
17.8 thousand cells per microliter
Standard Deviation 10.0
|
14.7 thousand cells per microliter
Standard Deviation 8.8
|
21.7 thousand cells per microliter
Standard Deviation 16.2
|
|
Total White Blood Cell (WBC) Count
Day 7
|
14.3 thousand cells per microliter
Standard Deviation 6.7
|
12.5 thousand cells per microliter
Standard Deviation 5.1
|
12.3 thousand cells per microliter
Standard Deviation 2.4
|
|
Total White Blood Cell (WBC) Count
Change from Screening to Day 7
|
-5.0 thousand cells per microliter
Standard Deviation 9.3
|
-3.0 thousand cells per microliter
Standard Deviation 10.9
|
-11.2 thousand cells per microliter
Standard Deviation 14.9
|
PRIMARY outcome
Timeframe: Screening and Day 7Population: The safety analysis population consisted of all randomized patients who received study drug (N=43). The number of patients analyzed is the number of patients with non-missing data in this population.
Screening PLT results, Day 7 PLT results, and change in PLT from screening to Day 7
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=15 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=17 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=11 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Platelet (PLT) Count
Screening
|
300.2 thousand cells per microliter
Standard Deviation 182.2
|
215.1 thousand cells per microliter
Standard Deviation 82.0
|
255.3 thousand cells per microliter
Standard Deviation 130.0
|
|
Platelet (PLT) Count
Day 7
|
401.5 thousand cells per microliter
Standard Deviation 168.8
|
341.8 thousand cells per microliter
Standard Deviation 140.6
|
318.3 thousand cells per microliter
Standard Deviation 148.2
|
|
Platelet (PLT) Count
Change from Screening to Day 7
|
81.8 thousand cells per microliter
Standard Deviation 237.1
|
125.1 thousand cells per microliter
Standard Deviation 144.6
|
49.9 thousand cells per microliter
Standard Deviation 160.2
|
PRIMARY outcome
Timeframe: Screening and Day 7Population: The safety analysis population consisted of all randomized patients who received study drug. One of the 0.25 mg/kg patients did not have a Screening INR result. Participant numbers in some rows differ from the overall number analyzed due to missing data as conveyed in the number of participants in each treatment group within a row.
Screening INR results, Day 7 INR results, and change in INR from screening to Day 7. In general, the higher the INR value, the longer it takes for blood to form a clot.
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=14 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=17 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=11 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
International Normalized Ratio (INR)
Screening
|
1.29 unitless
Standard Deviation 0.22
|
1.43 unitless
Standard Deviation 0.33
|
1.41 unitless
Standard Deviation 0.38
|
|
International Normalized Ratio (INR)
Day 7
|
1.2 unitless
Standard Deviation 0.1
|
1.2 unitless
Standard Deviation 0.1
|
1.3 unitless
Standard Deviation 0.3
|
|
International Normalized Ratio (INR)
Change from Screening to Day 7
|
-0.1 unitless
Standard Deviation 0.2
|
-0.2 unitless
Standard Deviation 0.3
|
-0.2 unitless
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: Pre-dose and up to 24 hours post-dosePopulation: Safety population: all randomized patients who received study drug. The number of patients analyzed is the number of patients with non-missing data as noted in results.
Pre-dose QTcF, post-dose QTcF, change in QTcF from pre-dose to post-dose
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=15 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=16 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=11 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
QT Interval With Fridericia's Correction (QTcF)
Pre-dose QTcF
|
419.1 msec
Standard Deviation 39.3
|
401.8 msec
Standard Deviation 16.8
|
405.1 msec
Standard Deviation 38.6
|
|
QT Interval With Fridericia's Correction (QTcF)
Post-dose QTcF
|
409.2 msec
Standard Deviation 23.1
|
403.1 msec
Standard Deviation 39.3
|
407.4 msec
Standard Deviation 29.6
|
|
QT Interval With Fridericia's Correction (QTcF)
Change in QTcF from pre-dose to post-dose
|
-9.9 msec
Standard Deviation 37.2
|
1.3 msec
Standard Deviation 36.1
|
8.9 msec
Standard Deviation 31.0
|
PRIMARY outcome
Timeframe: Pre-dose and up to 24 hours post-dosePopulation: Safety population: all randomized patients who received study drug. The number of patients analyzed is the number of patients with non-missing data as noted in results.
Number and percentage of patients with a change in QTcF of \> 30 msec; number and percentage of patients with a change in QTcF of \> 60 msec
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=15 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=16 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=10 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Categorical Change in QTcF
Patients with a change in QTcF of > 30 msec
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Categorical Change in QTcF
Patients with a change in QTcF of > 60 msec
|
1 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.Population: The pharmacokinetic (PK) analysis population consisted of all intent-to-treat (ITT) patients who received study drug and had a baseline and at least one post-baseline specified plasma sample obtained for quantitative analysis. The number of subjects analyzed reflects the number of subjects for which the parameter could be determined.
Area under the plasma concentration versus time curve (AUC) from time zero to infinity following a single dose of study drug, obtained by noncompartmental methods. It is an integrated measure of study drug plasma exposure.
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=7 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=14 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC)
|
8497 ng*min/mL
Interval 2836.0 to 14269.0
|
16921 ng*min/mL
Interval 4843.0 to 28952.0
|
—
|
PRIMARY outcome
Timeframe: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.Population: The pharmacokinetic (PK) analysis population consisted of all intent-to-treat (ITT) patients who received study drug and had a baseline and at least one post-baseline specified plasma sample obtained for quantitative analysis. The number of subjects analyzed reflects the number of subjects for which the parameter could be determined.
Maximum plasma concentration (observed)
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=11 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=16 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
899 ng/mL
Interval 98.0 to 2664.0
|
1484 ng/mL
Interval 661.0 to 3418.0
|
—
|
PRIMARY outcome
Timeframe: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.Population: The pharmacokinetic (PK) analysis population consisted of all intent-to-treat (ITT) patients who received study drug and had a baseline and at least one post-baseline specified plasma sample obtained for quantitative analysis. The number of subjects analyzed reflects the number of subjects for which the parameter could be determined.
Apparent terminal plasma half-life (T1/2) is the amount of time for plasma concentrations to decline by 50%.
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=7 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=14 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Apparent Terminal Plasma Half-life (T1/2)
|
2.61 minutes
Interval 1.28 to 18.99
|
4.89 minutes
Interval 1.53 to 14.16
|
—
|
PRIMARY outcome
Timeframe: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.Population: The pharmacokinetic (PK) analysis population consisted of all intent-to-treat (ITT) patients who received study drug and had a baseline and at least one post-baseline specified plasma sample obtained for quantitative analysis. The number of subjects analyzed reflects the number of subjects for which the parameter could be determined.
Clearance (CL) is the volume of plasma completely cleared of drug per unit of time.
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=7 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=14 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Clearance (CL)
|
29.42 mL/min/kg
Interval 17.52 to 88.14
|
29.55 mL/min/kg
Interval 17.27 to 103.24
|
—
|
PRIMARY outcome
Timeframe: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.Population: The pharmacokinetic (PK) analysis population consisted of all intent-to-treat (ITT) patients who received study drug and had a baseline and at least one post-baseline specified plasma sample obtained for quantitative analysis. The number of subjects analyzed reflects the number of subjects for which the parameter could be determined.
Apparent volume of distribution under steady state conditions (Vss) based on drug concentration in plasma
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=7 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=14 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Apparent Volume of Distribution Under Steady State Conditions (Vss)
|
100 mL/kg
Interval 53.0 to 157.0
|
135 mL/kg
Interval 36.0 to 318.0
|
—
|
SECONDARY outcome
Timeframe: Screening and Day 7Population: The population is all randomized patients who received study drug. The number of patients analyzed is the number of patients with non-missing data in this population.
Screening CRP results, Day 7 CRP results, and change in CRP from screening to Day 7
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=14 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=16 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=11 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
C-reactive Protein (CRP)
Change from Screening to Day 7
|
-19.2 mg/dL
Standard Deviation 14.6
|
-22.7 mg/dL
Standard Deviation 5.9
|
-20.5 mg/dL
Standard Deviation 11.0
|
|
C-reactive Protein (CRP)
Screening
|
29.2 mg/dL
Standard Deviation 12.3
|
27.5 mg/dL
Standard Deviation 6.2
|
20.6 mg/dL
Standard Deviation 13.2
|
|
C-reactive Protein (CRP)
Day 7
|
11.7 mg/dL
Standard Deviation 10.0
|
7.5 mg/dL
Standard Deviation 4.4
|
4.0 mg/dL
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Modified intent-to-treat (mITT) population: all randomized patients who received the proper study drug (AB103 or Placebo), had a definitive surgical diagnosis of NSTI, were not mis-dosed, and did not have a CD4 count \<200 cells/mm3. Proper study drug administration meant that study drug administration did not deviate from the planned administration.
Day 14 SOFA score is the sum of individual SOFA score components at Day 14. Results include last observation carried forward (LOCF) imputation for missing values. SOFA total scores range from 0 to 24, with higher scores reflecting a worse clinical status or outcome. A SOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=14 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=14 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=10 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Day 14 Sequential Organ Failure Assessment (SOFA) Score
|
1.07 score on a scale
Standard Deviation 1.00
|
0.71 score on a scale
Standard Deviation 0.83
|
2.70 score on a scale
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Modified intent-to-treat (mITT) population: all randomized patients who received the proper study drug (AB103 or Placebo), had a definitive surgical diagnosis of NSTI, were not mis-dosed, and did not have a CD4 count \<200 cells/mm3. Proper study drug administration meant that study drug administration did not deviate from the planned administration.
Number and percentage of patients with Day 14 Sequential Organ Failure Assessment (SOFA) score less than or equal to 1. SOFA total scores range from 0 to 24, with higher scores reflecting a worse clinical status or outcome. A SOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=14 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=14 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=10 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Day 14 Sequential Organ Failure Assessment (SOFA) Score Less Than or Equal to 1
|
10 Participants
|
13 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Modified intent-to-treat (mITT) population: all randomized patients who received the proper study drug (AB103 or Placebo), had a definitive surgical diagnosis of NSTI, were not mis-dosed, and did not have a CD4 count \<200 cells/mm3. Proper study drug administration meant that study drug administration did not deviate from the planned administration. The number of patients analyzed is the number of patients with non-missing data in this population.
The duration of hospital stay over the 28-day study period.
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=15 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=15 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=10 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Hospital Length of Stay (LOS)
|
17.1 days
Standard Deviation 7.96
|
17.4 days
Standard Deviation 9.07
|
20.0 days
Standard Deviation 6.93
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Modified intent-to-treat (mITT) population: all randomized patients who received the proper study drug (AB103 or Placebo), had a definitive surgical diagnosis of NSTI, were not mis-dosed, and did not have a CD4 count \<200 cells/mm3. Proper study drug administration meant that study drug administration did not deviate from the planned administration. The number of patients analyzed is the number of patients with non-missing data in this population.
The number of intensive care unit-free days (ICU-free days)
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=15 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=15 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=10 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Intensive Care Unit-free Days (ICU-free Days)
|
21.7 ICU-free days
Standard Deviation 8.48
|
21.3 ICU-free days
Standard Deviation 6.21
|
17.1 ICU-free days
Standard Deviation 9.88
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Modified intent-to-treat (mITT) population: all randomized patients who received the proper study drug (AB103 or Placebo), had a definitive surgical diagnosis of NSTI, were not mis-dosed, and did not have a CD4 count \<200 cells/mm3. Proper study drug administration meant that study drug administration did not deviate from the planned administration. The number of patients analyzed is the number of patients with non-missing data in this population.
The number of ventilator-free days (days without ventilator use)
Outcome measures
| Measure |
AB103 0.25 mg/kg
n=15 Participants
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=15 Participants
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=10 Participants
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Ventilator-free Days
|
23.5 ventilator-free days
Standard Deviation 8.75
|
24.1 ventilator-free days
Standard Deviation 6.25
|
20.8 ventilator-free days
Standard Deviation 9.14
|
Adverse Events
AB103 0.25 mg/kg
Serious events: 8 serious events
Other events: 14 other events
Deaths: 1 deaths
AB103 0.5 mg/kg
Serious events: 5 serious events
Other events: 16 other events
Deaths: 1 deaths
Placebo
Serious events: 4 serious events
Other events: 9 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
AB103 0.25 mg/kg
n=15 participants at risk
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=17 participants at risk
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=11 participants at risk
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Cardiac disorders
Hypotension
|
20.0%
3/15 • Number of events 3 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
13.3%
2/15 • Number of events 2 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
17.6%
3/17 • Number of events 3 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Infections and infestations
Septic shock
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
General disorders
Multi-organ failure
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Surgical and medical procedures
Withdrawal of life support
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Renal and urinary disorders
Renal failure acute
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Infections and infestations
Wound infection
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Injury, poisoning and procedural complications
Operative hemorrhage
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Surgical and medical procedures
Finger amputation
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Injury, poisoning and procedural complications
Wound complication
|
6.7%
1/15 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Number of events 2 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Acute lung injury
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Infections and infestations
Fungemia
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
Other adverse events
| Measure |
AB103 0.25 mg/kg
n=15 participants at risk
AB103 0.25 mg/kg administered as a single IV infusion
|
AB103 0.5 mg/kg
n=17 participants at risk
AB103 0.5 mg/kg administered as a single IV infusion
|
Placebo
n=11 participants at risk
Normal saline (0.9% sodium chloride) administered as a single IV infusion
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
13.3%
2/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
18.2%
2/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
18.2%
2/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Gastrointestinal disorders
Colonic pseudo-obstruction
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
General disorders
Face edema
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
General disorders
Fatigue
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
General disorders
Generalized edema
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
General disorders
Localized edema
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
General disorders
Multi-organ failure
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
General disorders
Edema peripheral
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
18.2%
2/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
General disorders
Pyrexia
|
20.0%
3/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
41.2%
7/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
18.2%
2/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Infections and infestations
Cellulitis
|
13.3%
2/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Infections and infestations
Fungemia
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Infections and infestations
Osteomyelitis
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Infections and infestations
Septic shock
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Infections and infestations
Soft tissue infection
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Infections and infestations
Wound infection
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Injury, poisoning and procedural complications
Operative hemorrhage
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Injury, poisoning and procedural complications
Post procedural hemorrhage
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Injury, poisoning and procedural complications
Wound complication
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Injury, poisoning and procedural complications
Wound hemorrhage
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Blood
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Blood albumin decreased
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Blood calcium decreased
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Blood creatinine increased
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Blood glucose increased
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Blood magnesium decreased
|
33.3%
5/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
35.3%
6/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
27.3%
3/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Blood phosphorus decreased
|
40.0%
6/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
41.2%
7/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Blood potassium decreased
|
33.3%
5/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
41.2%
7/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
27.3%
3/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Blood pressure increased
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Blood urine present
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Body temperature increased
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Clostridium test positive
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
11.8%
2/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Hematocrit decreased
|
33.3%
5/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
17.6%
3/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
27.3%
3/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Haptoglobin increased
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
International normalized ratio abnormal
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
International normalized ratio increased
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Investigations
Urine output decreased
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
18.2%
2/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.3%
2/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
23.5%
4/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
18.2%
2/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
18.2%
2/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
11.8%
2/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
18.2%
2/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
11.8%
2/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
27.3%
3/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Nervous system disorders
Lethargy
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Psychiatric disorders
Agitation
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
11.8%
2/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Psychiatric disorders
Confusional state
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Psychiatric disorders
Delirium
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Renal and urinary disorders
Renal failure acute
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
11.8%
2/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
18.2%
2/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Acute lung injury
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.3%
2/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
18.2%
2/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
13.3%
2/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
17.6%
3/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
18.2%
2/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Surgical and medical procedures
Finger amputation
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Surgical and medical procedures
Withdrawal of life support
|
0.00%
0/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
5.9%
1/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Vascular disorders
Arterial hemorrhage
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
0.00%
0/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
9.1%
1/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
|
Vascular disorders
Hypotension
|
20.0%
3/15 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
17.6%
3/17 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
36.4%
4/11 • Adverse events (AEs) included in this summary were to be collected from dosing through Day 7; serious adverse events (SAEs) included in this summary were to be collected from dosing through Day 28.
General, non-directed, systematic questioning of patients regarding AEs was to be performed at each study visit through Day 7. After Day 7, SAEs were to be assessed at each study visit through Day 28. Patients were able to voluntarily report AEs at any time.
|
Additional Information
Wayne M Dankner, MD, Chief Medical Officer
Atox Bio, Ltd.
Phone: 1 919-219-6377
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place