Trial Outcomes & Findings for A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI (NCT NCT02182440)
NCT ID: NCT02182440
Last Updated: 2020-03-23
Results Overview
Primary endpoint is calculated as the average of the standardized endogenous creatinine clearance values over the first seven days between the placebo and 1.6 mg/kg recAP arm. Standardized endogenous creatinine clearance is assessed on each days from D1 to Day 7 during a 6 +/- 1 hour period and calculated in mL/min as the mean creatinine clearance over the period. The study started with 4 treatment arms of which 0.4 mg/kg recAP and the 0.8 mg/kg recAP were dropped after the interim analysis. The number of the patients in the dropped arm are respectively 30 and 32. Therefore the statistical analysis has been performed only on the placebo and 1.6 mg/kg group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
301 participants
Primary outcome timeframe
7 days
Results posted on
2020-03-23
Participant Flow
Patients suffering sepsis associated acute kidney injury and admitted to the ICU were recruited from December 2014 to May 2017 in 10 European countries and the USA.53 Sites recruited patients. Sepsis diagnosis was established following the Sepsis-2 criteria and AKI diagnosis was established following the AKIN criteria.
Patients should show a continuation of AKI measured by a confirmatory serum creatinine value, which did not decrease \> or = 0.3 mg/dL compared to the diagnostic serum creatinine value or by a continuation of urine output of \< 0.5 mg/kg/h for more than 6 hours.
Participant milestones
| Measure |
Placebo
One hour IV infusion of Placebo once daily for three consecutive days
|
0.4 mg/kg (250 U/kg) recAP
One hour IV infusion of 0.4 mg/kg recAP once daily for three consecutive days
|
0.8 mg/kg (500 U/kg) recAP
One hour IV infusions of 0.8 mg/kg recAP once daily for three consecutive days
|
1.6 mg/kg (1000 U/kg) recAP
One hour IV infusions of 1.6 mg/kg recAP once daily for three consecutive days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
116
|
39
|
35
|
111
|
|
Overall Study
ITTcombined
|
116
|
31
|
32
|
111
|
|
Overall Study
ITTinterim
|
30
|
31
|
32
|
29
|
|
Overall Study
Safety Population
|
112
|
38
|
35
|
109
|
|
Overall Study
COMPLETED
|
71
|
25
|
24
|
81
|
|
Overall Study
NOT COMPLETED
|
45
|
14
|
11
|
30
|
Reasons for withdrawal
| Measure |
Placebo
One hour IV infusion of Placebo once daily for three consecutive days
|
0.4 mg/kg (250 U/kg) recAP
One hour IV infusion of 0.4 mg/kg recAP once daily for three consecutive days
|
0.8 mg/kg (500 U/kg) recAP
One hour IV infusions of 0.8 mg/kg recAP once daily for three consecutive days
|
1.6 mg/kg (1000 U/kg) recAP
One hour IV infusions of 1.6 mg/kg recAP once daily for three consecutive days
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
31
|
8
|
5
|
16
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
3
|
4
|
|
Overall Study
different, e.g adm other hospital
|
12
|
3
|
3
|
10
|
Baseline Characteristics
BMI is composed of weight and height measurements. For some patients no Height was available
Baseline characteristics by cohort
| Measure |
Placebo
n=116 Participants
One hour IV infusion of placebo once daily for 3 consecutive days
|
0.4 mg/kg (250 U/kg) recAP
n=31 Participants
One hour IV infusions of 0.4 mg/kg recAP once daily for three consecutive days
|
0.8 mg/kg (500 U/kg) recAP
n=32 Participants
One hour IV infusions of 0.8 mg/kg recAP once daily for three consecutive days
|
1.6 mg/kg (1000 U/kg) recAP
n=111 Participants
One hour IV infusions of 1.6 mg/kg recAP once daily for three consecutive days
|
Total
n=290 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
68.0 years
n=116 Participants
|
67.0 years
n=31 Participants
|
66.5 years
n=32 Participants
|
65.0 years
n=111 Participants
|
67.0 years
n=290 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=116 Participants
|
8 Participants
n=31 Participants
|
16 Participants
n=32 Participants
|
29 Participants
n=111 Participants
|
85 Participants
n=290 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=116 Participants
|
23 Participants
n=31 Participants
|
16 Participants
n=32 Participants
|
82 Participants
n=111 Participants
|
205 Participants
n=290 Participants
|
|
Race/Ethnicity, Customized
White
|
95 Participants
n=116 Participants
|
25 Participants
n=31 Participants
|
27 Participants
n=32 Participants
|
95 Participants
n=111 Participants
|
242 Participants
n=290 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=116 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=111 Participants
|
5 Participants
n=290 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=116 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=111 Participants
|
4 Participants
n=290 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=116 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=111 Participants
|
1 Participants
n=290 Participants
|
|
Race/Ethnicity, Customized
Not collected
|
16 Participants
n=116 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=32 Participants
|
14 Participants
n=111 Participants
|
38 Participants
n=290 Participants
|
|
Region of Enrollment
Austria
|
11 participants
n=116 Participants
|
2 participants
n=31 Participants
|
2 participants
n=32 Participants
|
11 participants
n=111 Participants
|
26 participants
n=290 Participants
|
|
Region of Enrollment
Netherlands
|
28 participants
n=116 Participants
|
8 participants
n=31 Participants
|
7 participants
n=32 Participants
|
28 participants
n=111 Participants
|
71 participants
n=290 Participants
|
|
Region of Enrollment
Belgium
|
12 participants
n=116 Participants
|
5 participants
n=31 Participants
|
5 participants
n=32 Participants
|
13 participants
n=111 Participants
|
35 participants
n=290 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=116 Participants
|
1 participants
n=31 Participants
|
1 participants
n=32 Participants
|
11 participants
n=111 Participants
|
27 participants
n=290 Participants
|
|
Region of Enrollment
Czechia
|
3 participants
n=116 Participants
|
2 participants
n=31 Participants
|
3 participants
n=32 Participants
|
5 participants
n=111 Participants
|
13 participants
n=290 Participants
|
|
Region of Enrollment
Ireland
|
1 participants
n=116 Participants
|
0 participants
n=31 Participants
|
0 participants
n=32 Participants
|
0 participants
n=111 Participants
|
1 participants
n=290 Participants
|
|
Region of Enrollment
Finland
|
6 participants
n=116 Participants
|
1 participants
n=31 Participants
|
3 participants
n=32 Participants
|
6 participants
n=111 Participants
|
16 participants
n=290 Participants
|
|
Region of Enrollment
United Kingdom
|
12 participants
n=116 Participants
|
5 participants
n=31 Participants
|
3 participants
n=32 Participants
|
11 participants
n=111 Participants
|
31 participants
n=290 Participants
|
|
Region of Enrollment
France
|
16 participants
n=116 Participants
|
4 participants
n=31 Participants
|
4 participants
n=32 Participants
|
14 participants
n=111 Participants
|
38 participants
n=290 Participants
|
|
Region of Enrollment
Spain
|
9 participants
n=116 Participants
|
3 participants
n=31 Participants
|
4 participants
n=32 Participants
|
7 participants
n=111 Participants
|
23 participants
n=290 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=116 Participants
|
0 participants
n=31 Participants
|
0 participants
n=32 Participants
|
5 participants
n=111 Participants
|
9 participants
n=290 Participants
|
|
BMI
|
26.3 kg/m2
n=115 Participants • BMI is composed of weight and height measurements. For some patients no Height was available
|
25.8 kg/m2
n=30 Participants • BMI is composed of weight and height measurements. For some patients no Height was available
|
27.4 kg/m2
n=29 Participants • BMI is composed of weight and height measurements. For some patients no Height was available
|
26.8 kg/m2
n=110 Participants • BMI is composed of weight and height measurements. For some patients no Height was available
|
26.6 kg/m2
n=284 Participants • BMI is composed of weight and height measurements. For some patients no Height was available
|
|
APACHE II
|
26.0 units on a scale
n=116 Participants • One patient did not have an APACHE score at baseline
|
30.0 units on a scale
n=31 Participants • One patient did not have an APACHE score at baseline
|
26.0 units on a scale
n=32 Participants • One patient did not have an APACHE score at baseline
|
25.0 units on a scale
n=110 Participants • One patient did not have an APACHE score at baseline
|
26.0 units on a scale
n=289 Participants • One patient did not have an APACHE score at baseline
|
|
SOFA score
|
10.0 units on a scale
n=113 Participants • Not all patients in ITT did had a baseline SOAFA score
|
10.0 units on a scale
n=29 Participants • Not all patients in ITT did had a baseline SOAFA score
|
9.0 units on a scale
n=32 Participants • Not all patients in ITT did had a baseline SOAFA score
|
10.0 units on a scale
n=108 Participants • Not all patients in ITT did had a baseline SOAFA score
|
10.0 units on a scale
n=282 Participants • Not all patients in ITT did had a baseline SOAFA score
|
|
Mechanical ventilation
|
68 Participants
n=116 Participants
|
23 Participants
n=31 Participants
|
20 Participants
n=32 Participants
|
70 Participants
n=111 Participants
|
181 Participants
n=290 Participants
|
|
Vasopressor/ionotropic therapy
|
103 Participants
n=116 Participants
|
28 Participants
n=31 Participants
|
30 Participants
n=32 Participants
|
102 Participants
n=111 Participants
|
263 Participants
n=290 Participants
|
|
Heart rate
|
98.0 beats/min
n=116 Participants
|
93.0 beats/min
n=31 Participants
|
90.0 beats/min
n=32 Participants
|
95.0 beats/min
n=111 Participants
|
95.5 beats/min
n=290 Participants
|
|
Bloodpressure
Systolic bloodpressure
|
112.0 mmHg
n=116 Participants • Lacking blood pressure results
|
108.0 mmHg
n=31 Participants • Lacking blood pressure results
|
118.5 mmHg
n=32 Participants • Lacking blood pressure results
|
107.0 mmHg
n=110 Participants • Lacking blood pressure results
|
110 mmHg
n=289 Participants • Lacking blood pressure results
|
|
Bloodpressure
Diastolic bloodpressure
|
56.5 mmHg
n=116 Participants • Lacking blood pressure results
|
54.0 mmHg
n=31 Participants • Lacking blood pressure results
|
58.0 mmHg
n=32 Participants • Lacking blood pressure results
|
55.0 mmHg
n=111 Participants • Lacking blood pressure results
|
56.0 mmHg
n=290 Participants • Lacking blood pressure results
|
|
Body temperature
<36oC
|
11 Participants
n=114 Participants • Missing data
|
4 Participants
n=31 Participants • Missing data
|
5 Participants
n=32 Participants • Missing data
|
11 Participants
n=108 Participants • Missing data
|
31 Participants
n=285 Participants • Missing data
|
|
Body temperature
>= 36oC and =< 38oC
|
76 Participants
n=114 Participants • Missing data
|
20 Participants
n=31 Participants • Missing data
|
22 Participants
n=32 Participants • Missing data
|
79 Participants
n=108 Participants • Missing data
|
197 Participants
n=285 Participants • Missing data
|
|
Body temperature
>38oC
|
27 Participants
n=114 Participants • Missing data
|
7 Participants
n=31 Participants • Missing data
|
5 Participants
n=32 Participants • Missing data
|
18 Participants
n=108 Participants • Missing data
|
57 Participants
n=285 Participants • Missing data
|
|
eGFR
|
37.5 mL/min
n=102 Participants • Missing data
|
27.2 mL/min
n=27 Participants • Missing data
|
25.6 mL/min
n=28 Participants • Missing data
|
29.7 mL/min
n=98 Participants • Missing data
|
31.8 mL/min
n=255 Participants • Missing data
|
|
Endogenous Creatinine clearance
Baseline
|
31.8 mL/min
n=49 Participants • Missing data
|
14.4 mL/min
n=10 Participants • Missing data
|
26.0 mL/min
n=12 Participants • Missing data
|
24.1 mL/min
n=46 Participants • Missing data
|
27.9 mL/min
n=117 Participants • Missing data
|
|
Endogenous Creatinine clearance
Day 1
|
35.9 mL/min
n=103 Participants • Missing data
|
28.3 mL/min
n=30 Participants • Missing data
|
25.2 mL/min
n=31 Participants • Missing data
|
26.0 mL/min
n=102 Participants • Missing data
|
29.4 mL/min
n=266 Participants • Missing data
|
|
AKI stage
AKI Stage 1
|
91 Participants
n=112 Participants • Missing data
|
22 Participants
n=31 Participants • Missing data
|
23 Participants
n=32 Participants • Missing data
|
81 Participants
n=109 Participants • Missing data
|
217 Participants
n=284 Participants • Missing data
|
|
AKI stage
AKI Stage 2
|
16 Participants
n=112 Participants • Missing data
|
5 Participants
n=31 Participants • Missing data
|
5 Participants
n=32 Participants • Missing data
|
17 Participants
n=109 Participants • Missing data
|
43 Participants
n=284 Participants • Missing data
|
|
AKI stage
AKI Stage 3
|
5 Participants
n=112 Participants • Missing data
|
4 Participants
n=31 Participants • Missing data
|
4 Participants
n=32 Participants • Missing data
|
11 Participants
n=109 Participants • Missing data
|
24 Participants
n=284 Participants • Missing data
|
|
Urine output
|
60.0 mL/h
n=53 Participants • Missing data
|
50.0 mL/h
n=13 Participants • Missing data
|
27.4 mL/h
n=14 Participants • Missing data
|
39.1 mL/h
n=50 Participants • Missing data
|
46.3 mL/h
n=130 Participants • Missing data
|
|
Serum Creatinine
|
1.8 mg/dL
n=113 Participants • Missing data
|
2.3 mg/dL
n=29 Participants • Missing data
|
1.9 mg/dL
n=32 Participants • Missing data
|
2.0 mg/dL
n=110 Participants • Missing data
|
1.9 mg/dL
n=284 Participants • Missing data
|
PRIMARY outcome
Timeframe: 7 daysPopulation: ITT combined includes all patients randomized in part 1 and part 2 of the study, excluding patients recruited whilst the interim analysis is performed to treatment arms not selected for Part 2. Some values were discarded by the adjudication committee.
Primary endpoint is calculated as the average of the standardized endogenous creatinine clearance values over the first seven days between the placebo and 1.6 mg/kg recAP arm. Standardized endogenous creatinine clearance is assessed on each days from D1 to Day 7 during a 6 +/- 1 hour period and calculated in mL/min as the mean creatinine clearance over the period. The study started with 4 treatment arms of which 0.4 mg/kg recAP and the 0.8 mg/kg recAP were dropped after the interim analysis. The number of the patients in the dropped arm are respectively 30 and 32. Therefore the statistical analysis has been performed only on the placebo and 1.6 mg/kg group.
Outcome measures
| Measure |
Placebo
n=106 Participants
One hour IV infusion of Placebo once daily for three consecutive days
|
0.4 mg/kg (250 U/kg) recAP
n=30 Participants
One hour IV infusions of 0.4 mg/kg recAP once daily for three consecutive days
|
0.8 mg/kg (500 U/kg) recAP
n=32 Participants
One hour IV infusions of 0.8 mg/kg recAP once daily for three consecutive days
|
1.6 mg/kg (1000 U/kg) recAP
n=108 Participants
One hour IV infusions of 1.6 mg/kg recAP once daily for three consecutive days
|
|---|---|---|---|---|
|
Area Under the Time Corrected Endogenous Creatinine Clearance From Day 1 to Day 7 (AUC1-7)
Part 2
|
44.51 mL/min
Interval 17.71 to 108.51
|
—
|
—
|
51.76 mL/min
Interval 17.61 to 94.58
|
|
Area Under the Time Corrected Endogenous Creatinine Clearance From Day 1 to Day 7 (AUC1-7)
Part 1
|
41.35 mL/min
Interval 19.0 to 130.15
|
43.30 mL/min
Interval 16.4 to 93.3
|
64.25 mL/min
Interval 14.2 to 104.0
|
61.10 mL/min
Interval 6.8 to 93.5
|
|
Area Under the Time Corrected Endogenous Creatinine Clearance From Day 1 to Day 7 (AUC1-7)
Part 1 + Part 2
|
45.6 mL/min
Interval 17.7 to 112.4
|
46.95 mL/min
Interval 6.58 to 88.4
|
63.54 mL/min
Interval 8.07 to 96.77
|
55.1 mL/min
Interval 15.0 to 93.9
|
SECONDARY outcome
Timeframe: 28 daysPopulation: ITT combined
During the study the days on Renal Replacement Therapy (RRT) was recorded for each patients. During the first 7 days of the study (D1 to D7 included), patients were only allowed to receive continuous RRT, thereafter patients were also allowed to receive intermittent RRT. Standardization of RRT was attempted by providing guidelines to start and stop RRT (see protocol). Statistical analysis was only performed on the placebo and 1.6 mg/kg recAP arm due to the small number of patients treated with the doses of 0.4 mg/kg and 0.8 mg/kg recAP. Those two doses were dropped in part 2 of the study.
Outcome measures
| Measure |
Placebo
n=116 Participants
One hour IV infusion of Placebo once daily for three consecutive days
|
0.4 mg/kg (250 U/kg) recAP
n=31 Participants
One hour IV infusions of 0.4 mg/kg recAP once daily for three consecutive days
|
0.8 mg/kg (500 U/kg) recAP
n=32 Participants
One hour IV infusions of 0.8 mg/kg recAP once daily for three consecutive days
|
1.6 mg/kg (1000 U/kg) recAP
n=111 Participants
One hour IV infusions of 1.6 mg/kg recAP once daily for three consecutive days
|
|---|---|---|---|---|
|
Number of Participants Who Had Renal Replacement Therapy (RRT) During the Period Day 1 to Day 28, Inclusive
|
34 Participants
|
11 Participants
|
7 Participants
|
40 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28Population: ITT set
Number of patients in the ITT set, who died in the period between day 1 to day 28. Statistical analysis was only performed on the placebo and 1.6 mg/kg recAP arm due to the small number of patients treated with the doses of 0.4 mg/kg and 0.8 mg/kg recAP. Those two doses were dropped in part 2 of the study.
Outcome measures
| Measure |
Placebo
n=116 Participants
One hour IV infusion of Placebo once daily for three consecutive days
|
0.4 mg/kg (250 U/kg) recAP
n=31 Participants
One hour IV infusions of 0.4 mg/kg recAP once daily for three consecutive days
|
0.8 mg/kg (500 U/kg) recAP
n=32 Participants
One hour IV infusions of 0.8 mg/kg recAP once daily for three consecutive days
|
1.6 mg/kg (1000 U/kg) recAP
n=111 Participants
One hour IV infusions of 1.6 mg/kg recAP once daily for three consecutive days
|
|---|---|---|---|---|
|
All-cause Mortality at Day 28
|
31 Participants
|
8 Participants
|
4 Participants
|
16 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 90Population: ITT
Number of patients in the ITT set, who died in the period between Day 1 and Day 90 Statistical analysis was only performed on the placebo and 1.6 mg/kg recAP arm due to the small number of patients treated with the doses of 0.4 mg/kg and 0.8 mg/kg recAP. Those two doses were dropped in part 2 of the study.
Outcome measures
| Measure |
Placebo
n=116 Participants
One hour IV infusion of Placebo once daily for three consecutive days
|
0.4 mg/kg (250 U/kg) recAP
n=31 Participants
One hour IV infusions of 0.4 mg/kg recAP once daily for three consecutive days
|
0.8 mg/kg (500 U/kg) recAP
n=32 Participants
One hour IV infusions of 0.8 mg/kg recAP once daily for three consecutive days
|
1.6 mg/kg (1000 U/kg) recAP
n=111 Participants
One hour IV infusions of 1.6 mg/kg recAP once daily for three consecutive days
|
|---|---|---|---|---|
|
All-cause Mortality at Day 90
|
34 Participants
|
9 Participants
|
6 Participants
|
19 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 60Make 60 is composed of patients that meet at least one of the following criteria at day 60: 1. had eGFR \< 60 mL/min (calculated by using the CKD-EPI formula) or 2. became dialysis dependent up to Day 60 or 3. died prior to Day 60 Statistical analysis was only performed on the placebo and 1.6 mg/kg recAP arm due to the small number of patients treated with the doses of 0.4 mg/kg and 0.8 mg/kg recAP. Those two doses were dropped in part 2 of the study.
Outcome measures
| Measure |
Placebo
n=116 Participants
One hour IV infusion of Placebo once daily for three consecutive days
|
0.4 mg/kg (250 U/kg) recAP
n=31 Participants
One hour IV infusions of 0.4 mg/kg recAP once daily for three consecutive days
|
0.8 mg/kg (500 U/kg) recAP
n=32 Participants
One hour IV infusions of 0.8 mg/kg recAP once daily for three consecutive days
|
1.6 mg/kg (1000 U/kg) recAP
n=111 Participants
One hour IV infusions of 1.6 mg/kg recAP once daily for three consecutive days
|
|---|---|---|---|---|
|
Number of Participants Meeting at Least One MAKE 60 Criteria
|
46 Participants
|
13 Participants
|
11 Participants
|
30 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 90Population: ITT
Make 90 includes patients who meet at least one of the following parameters at Day 90: 1. had eGFR \<60 ml/min at Day 90, estimated by the CKD-EPI formula based on a serum creatinine or 2. was dialysis dependent up to Day 90 or 3. was hospitalized for a new episode of acute kidney injury prior to Day 90 or 4. died, prior to Day 90 Statistical analysis was only performed on the placebo and 1.6 mg/kg recAP arm due to the small number of patients treated with the doses of 0.4 mg/kg and 0.8 mg/kg recAP. Those two doses were dropped in part 2 of the study.
Outcome measures
| Measure |
Placebo
n=116 Participants
One hour IV infusion of Placebo once daily for three consecutive days
|
0.4 mg/kg (250 U/kg) recAP
n=31 Participants
One hour IV infusions of 0.4 mg/kg recAP once daily for three consecutive days
|
0.8 mg/kg (500 U/kg) recAP
n=32 Participants
One hour IV infusions of 0.8 mg/kg recAP once daily for three consecutive days
|
1.6 mg/kg (1000 U/kg) recAP
n=111 Participants
One hour IV infusions of 1.6 mg/kg recAP once daily for three consecutive days
|
|---|---|---|---|---|
|
Number of Patients Who Meet at Least One of the MAKE 90 Criteria
|
46 Participants
|
13 Participants
|
10 Participants
|
29 Participants
|
Adverse Events
Placebo
Serious events: 56 serious events
Other events: 111 other events
Deaths: 33 deaths
0.4 mg/kg (250 U/kg) recAP
Serious events: 18 serious events
Other events: 35 other events
Deaths: 10 deaths
0.8 mg/kg (500 U/kg) recAP
Serious events: 11 serious events
Other events: 31 other events
Deaths: 6 deaths
1.6 mg/kg (1000 U/kg) recAP
Serious events: 47 serious events
Other events: 103 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Placebo
n=112 participants at risk
One hour IV infusion of Placebo once daily for three consecutive days
|
0.4 mg/kg (250 U/kg) recAP
n=38 participants at risk
One hour IV infusion of 0.4 mg/kg recAP once daily for three consecutive days
|
0.8 mg/kg (500 U/kg) recAP
n=35 participants at risk
One hour IV infusions of 0.8 mg/kg recAP once daily for three consecutive days
|
1.6 mg/kg (1000 U/kg) recAP
n=109 participants at risk
One hour IV infusions of 1.6 mg/kg recAP once daily for three consecutive days
|
|---|---|---|---|---|
|
Infections and infestations
Abdominal abscess
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Abdominal sepsis
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Candida infection
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Cholecystitis infective
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Clostridium Difficile infection
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Gastroenteritis
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Iatrogenic infection
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Lung abscess
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
1.8%
2/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Necrotising soft tissue infection
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Peritonitis
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Pneumonia
|
2.7%
3/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
3.7%
4/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Pneumonia herpes viral
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Septic shock
|
9.8%
11/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
11.4%
4/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.8%
3/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Colonic pseudo-obstruction
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Gastric fistula
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
1.8%
2/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Gastrointestinal haemorrage
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
1.8%
2/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
1.8%
2/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Intral abdominal haemorrhage
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Ischemia enteritis
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Acute lung injury
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.8%
2/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.9%
10/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
10.5%
4/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
3.7%
4/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Cardiac disorders
Acute myocardial infarction
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Cardiac disorders
Arterial fibrillation
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Cardiac disorders
Cardiac arrest
|
3.6%
4/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
3.7%
4/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Cardiac disorders
Cardiac failure
|
1.8%
2/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Cardiac disorders
Cardiac failure acute
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Cardiac disorders
Cardiogenic shock
|
1.8%
2/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Cardiac disorders
Myocardiac infarction
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
1.8%
2/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Cardiac disorders
Ventricular tachycardia
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
General disorders
Astenia
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
General disorders
General physical health deterioration
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
General disorders
Multiple organ dysfunction syndrome
|
6.2%
7/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
4.6%
5/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Vascular disorders
Arterial haemorrhage
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Vascular disorders
Arterial insufficiency
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Vascular disorders
Capillary disorder
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Vascular disorders
Peripheral ischemia
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
1.8%
2/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Vascular disorders
Shock
|
1.8%
2/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Vascular disorders
Shock haemorrhage
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Nervous system disorders
Metabolic encepalopathy
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Nervous system disorders
Neuromyopathy
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Nervous system disorders
Sedation
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
2/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
1.8%
2/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Renal and urinary disorders
Acute kidney injury
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Renal and urinary disorders
Renal failure
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Investigations
Electrocardiogram QT prolonged
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Investigations
General physical condition abnormal
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Injury, poisoning and procedural complications
Anastomic leak
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Hepatobiliary disorders
Cholestasis
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Hepatobiliary disorders
Hepatic failure
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Hepatobiliary disorders
Hepatic haematoma
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Metabolism and nutrition disorders
Caxhexia
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Musculoskeletal and connective tissue disorders
Connective tissue disorders fasciitis
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
Other adverse events
| Measure |
Placebo
n=112 participants at risk
One hour IV infusion of Placebo once daily for three consecutive days
|
0.4 mg/kg (250 U/kg) recAP
n=38 participants at risk
One hour IV infusion of 0.4 mg/kg recAP once daily for three consecutive days
|
0.8 mg/kg (500 U/kg) recAP
n=35 participants at risk
One hour IV infusions of 0.8 mg/kg recAP once daily for three consecutive days
|
1.6 mg/kg (1000 U/kg) recAP
n=109 participants at risk
One hour IV infusions of 1.6 mg/kg recAP once daily for three consecutive days
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
8.0%
9/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
8.6%
3/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.8%
3/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Constipation
|
11.6%
13/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
8.6%
3/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
11.0%
12/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Diarrhoea
|
10.7%
12/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
8.6%
3/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
14.7%
16/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Ileus apralytic
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
6.4%
7/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
7.1%
8/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
7.3%
8/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Nausea
|
12.5%
14/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
10.5%
4/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
8.6%
3/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
11.9%
13/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
5/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
7.9%
3/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.5%
6/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Cellulitis
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Fungal infection
|
2.7%
3/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Herpes simplex
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
7.9%
3/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Infections and infestations
Oral herpes
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.8%
3/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.7%
3/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
6.4%
7/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.5%
5/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.5%
6/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
8.9%
10/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.5%
6/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
7.9%
3/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
8.6%
3/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
8.3%
9/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.2%
17/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
13.2%
5/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
8.6%
3/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
12.8%
14/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.6%
4/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
1.8%
2/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.6%
4/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.5%
6/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
2.7%
3/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.8%
3/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
2.7%
3/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.8%
3/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
General disorders
Generalised oedemia
|
4.5%
5/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
7.9%
3/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
8.3%
9/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
General disorders
Multiple organ dysfunction syndrome
|
6.2%
7/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
4.6%
5/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
General disorders
Oedema peripheral
|
15.2%
17/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
10.5%
4/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
14.3%
5/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
19.3%
21/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
General disorders
Pain
|
4.5%
5/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
General disorders
Pyrexia
|
6.2%
7/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
8.6%
3/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
9.2%
10/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Cardiac disorders
Arterial flutter
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.8%
3/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Cardiac disorders
Bradycardia
|
2.7%
3/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Cardiac disorders
Sinus tachycardia
|
4.5%
5/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
6.4%
7/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Psychiatric disorders
Agitation
|
5.4%
6/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
11.9%
13/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Psychiatric disorders
Anxiety
|
2.7%
3/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
7.9%
3/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.8%
3/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Psychiatric disorders
Delirium
|
17.9%
20/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
13.2%
5/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
14.3%
5/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
12.8%
14/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Psychiatric disorders
Insomnia
|
8.9%
10/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
11.9%
13/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
4.5%
5/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.5%
6/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
8/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
7.9%
3/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.8%
11/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
7.9%
3/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
11.4%
4/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
12.8%
14/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Vascular disorders
Hypertension
|
8.9%
10/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
17.1%
6/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
12.8%
14/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Vascular disorders
Hypotension
|
8.9%
10/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
13.2%
5/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.5%
6/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Vascular disorders
Phlebitis
|
1.8%
2/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
1.8%
2/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Investigations
Blood phosphorus decreased
|
1.8%
2/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.8%
3/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Investigations
Breath sound abnormal
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Investigations
Cardiac murmur
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Investigations
Haemoglobin decreased
|
8.0%
9/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
7.3%
8/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.8%
2/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
8.3%
9/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.7%
3/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.92%
1/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Nervous system disorders
Intensive care unit acquired weakness
|
3.6%
4/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
4.6%
5/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.8%
3/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Gastrointestinal disorders
Abdominal distension
|
3.6%
4/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.3%
2/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
3.7%
4/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
7.9%
3/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.9%
1/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
1.8%
2/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Vascular disorders
Haematoma
|
4.5%
5/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.6%
1/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
1.8%
2/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Investigations
Blood potassium decreased
|
1.8%
2/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
5.7%
2/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
1.8%
2/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.89%
1/112 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
0.00%
0/38 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
8.6%
3/35 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
2.8%
3/109 • Adverse events were collected from the time the patient signed the informed consent form until Day 28
|
Additional Information
JAcques Arend MD, DiMD, Chief Medical Officer
AM-Pharma B.V.
Phone: +31302598836
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place