Trial Outcomes & Findings for Voluven® in Paediatric Patients (NCT NCT00860405)
NCT ID: NCT00860405
Last Updated: 2011-11-02
Results Overview
Total volume of study drug plus rescue colloid, if applicable
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
Day 1 (intraoperatively)
Results posted on
2011-11-02
Participant Flow
Participants were recruited in paediatric care units of 2 hospitals in Austria and Belgium from March 2009 (FPI) until July 2010 and were followed up until August 2010 (LPO).
Participants were screened in paediatric care units of the participating 2 study sites in Austria and Belgium.
Participant milestones
| Measure |
Voluven® Arm
6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
|
HSA 5% Arm (Comparison Group)
Human Serum Albumin (HSA) 50g/L, i.v.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
Completed Treatment
|
31
|
29
|
|
Overall Study
Day 28 Follow-up Performed
|
31
|
29
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Voluven® Arm
6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
|
HSA 5% Arm (Comparison Group)
Human Serum Albumin (HSA) 50g/L, i.v.
|
|---|---|---|
|
Overall Study
Main reason: Follow-up data not complete
|
5
|
4
|
Baseline Characteristics
Voluven® in Paediatric Patients
Baseline characteristics by cohort
| Measure |
Voluven® Arm
n=31 Participants
6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
|
HSA 5% Arm (Comparison Group)
n=30 Participants
Human Serum Albumin (HSA) 50g/L, i.v.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
5.2 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
4.0 years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
4.6 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Weight
|
18.2 kg
STANDARD_DEVIATION 8.9 • n=5 Participants
|
15.4 kg
STANDARD_DEVIATION 4.4 • n=7 Participants
|
16.9 kg
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Height
|
106.6 cm
STANDARD_DEVIATION 16.8 • n=5 Participants
|
101.3 cm
STANDARD_DEVIATION 12.8 • n=7 Participants
|
104.0 cm
STANDARD_DEVIATION 15.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (intraoperatively)Population: Per-protocol population (PP) = All patients in the Intention-to-treat (ITT) set without any major protocol violation.
Total volume of study drug plus rescue colloid, if applicable
Outcome measures
| Measure |
Voluven® Arm
n=29 Participants
6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
|
HSA 5% Arm (Comparison Group)
n=26 Participants
Human Serum Albumin (HSA) 50g/L, i.v.
|
|---|---|---|
|
Total Volume of Colloid Solution Required Intraoperatively
|
36.6 ml/kg
Standard Deviation 11.76
|
36.97 ml/kg
Standard Deviation 11.86
|
SECONDARY outcome
Timeframe: Beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)Population: Per-protocol population (PP) = All patients in the ITT set without any major protocol violation
Mean arterial pressure (MAP) from beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)
Outcome measures
| Measure |
Voluven® Arm
n=29 Participants
6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
|
HSA 5% Arm (Comparison Group)
n=26 Participants
Human Serum Albumin (HSA) 50g/L, i.v.
|
|---|---|---|
|
Mean Arterial Pressure (MAP)
T0, Baseline
|
64.1 mm Hg
Standard Deviation 11.3
|
66.5 mm Hg
Standard Deviation 12.5
|
|
Mean Arterial Pressure (MAP)
T1, before ECC (Extracorporeal circulation)
|
54.0 mm Hg
Standard Deviation 7.4
|
51.3 mm Hg
Standard Deviation 8.0
|
|
Mean Arterial Pressure (MAP)
T2, after ECC
|
56.6 mm Hg
Standard Deviation 7.6
|
58.2 mm Hg
Standard Deviation 9.7
|
|
Mean Arterial Pressure (MAP)
T3, after skin closure
|
61.2 mm Hg
Standard Deviation 9.7
|
62.0 mm Hg
Standard Deviation 9.9
|
|
Mean Arterial Pressure (MAP)
T4, arrival on ICU
|
65.3 mm Hg
Standard Deviation 14.8
|
65.2 mm Hg
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Per-protocol population (PP) = All patients in the ITT set without any major protocol violation
Quantity of total fluids administered from beginning of anaesthesia until 2nd postop morning
Outcome measures
| Measure |
Voluven® Arm
n=29 Participants
6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
|
HSA 5% Arm (Comparison Group)
n=26 Participants
Human Serum Albumin (HSA) 50g/L, i.v.
|
|---|---|---|
|
Fluid Input
|
246.8 ml/kg
Standard Deviation 119.3
|
248.2 ml/kg
Standard Deviation 105.8
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Per-protocol population (PP) = All patients in the ITT set without any major protocol violation.
Quantity of total fluids excreted or lost from beginning of anaesthesia until 2nd postop morning
Outcome measures
| Measure |
Voluven® Arm
n=29 Participants
6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
|
HSA 5% Arm (Comparison Group)
n=26 Participants
Human Serum Albumin (HSA) 50g/L, i.v.
|
|---|---|---|
|
Fluid Output
|
195.5 ml/kg
Standard Deviation 95.7
|
181.1 ml/kg
Standard Deviation 68.3
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Per-protocol population (PP) = All patients in the ITT set without any major protocol violation.
Balance of total fluid input and total fluid output
Outcome measures
| Measure |
Voluven® Arm
n=29 Participants
6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
|
HSA 5% Arm (Comparison Group)
n=26 Participants
Human Serum Albumin (HSA) 50g/L, i.v.
|
|---|---|---|
|
Fluid Balance
|
51.3 ml/kg
Standard Deviation 47.5
|
67.1 ml/kg
Standard Deviation 62.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 daysPopulation: Safety Population (SAF) = All randomized patients treated with study drug.
Calculated perioperative RBC loss = Predicted blood volume1 × (hematocrit \[baseline\] - hematocrit \[2nd postop morning\]) + transfused RBC volume2; 1. Predicted blood volume (mL) = 80 × body weight (kg) 2. Transfused RBC volume = 0.7 × infused packed RBC
Outcome measures
| Measure |
Voluven® Arm
n=31 Participants
6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
|
HSA 5% Arm (Comparison Group)
n=29 Participants
Human Serum Albumin (HSA) 50g/L, i.v.
|
|---|---|---|
|
Calculated Perioperative Red Blood Cell (RBC) Loss
|
14.4 ml/kg
Standard Deviation 14.4
|
15.3 ml/kg
Standard Deviation 15.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From admission to ICU until discharge from ICUPopulation: Safety Population (SAF) = All randomized patients treated with study drug.
Length of stay (number of days) on the intensive care unit (ICU).
Outcome measures
| Measure |
Voluven® Arm
n=31 Participants
6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
|
HSA 5% Arm (Comparison Group)
n=29 Participants
Human Serum Albumin (HSA) 50g/L, i.v.
|
|---|---|---|
|
Length of Stay on the Intensive Care Unit (ICU)
|
3.1 Days
Interval 2.0 to 5.8
|
3.1 Days
Interval 2.3 to 6.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From screening to end of follow-upPopulation: Safety Population (SAF) = All randomized patients treated with study drug
Mortality was reported for the time period from screening until the end of follow-up.
Outcome measures
| Measure |
Voluven® Arm
n=31 Participants
6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
|
HSA 5% Arm (Comparison Group)
n=29 Participants
Human Serum Albumin (HSA) 50g/L, i.v.
|
|---|---|---|
|
Mortality
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline until 2nd postop morning.Population: Safety Population (SAF) = All randomized patients treated with study drug.
Acute renal failure was defined as a two fold increase in serum creatinine concentration over the value at baseline at any time after baseline.
Outcome measures
| Measure |
Voluven® Arm
n=31 Participants
6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
|
HSA 5% Arm (Comparison Group)
n=29 Participants
Human Serum Albumin (HSA) 50g/L, i.v.
|
|---|---|---|
|
Acute Renal Failure (ARF)
|
4 Participants
|
4 Participants
|
Adverse Events
Voluven® Arm
Serious events: 11 serious events
Other events: 30 other events
Deaths: 0 deaths
HSA 5% Arm (Comparison Group)
Serious events: 7 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Voluven® Arm
n=31 participants at risk
6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
|
HSA 5% Arm (Comparison Group)
n=29 participants at risk
Human Serum Albumin (HSA) 50g/L, i.v.
|
|---|---|---|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Cardiac disorders
Atrioventricular block complete
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Cardiac disorders
Cardiac failure
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Cardiac disorders
Cardiopulmonary failure
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Cardiac disorders
Left ventricular failure
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Cardiac disorders
Pericardial effusion
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Gastrointestinal disorders
Internal hernia
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
General disorders
Device breakage
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
General disorders
Medical device complication
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
General disorders
Multi-organ failure
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
6.9%
2/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Lung infection
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Lung infection pseudomonal
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Pneumonia
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Post procedural pneumonia
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
10.3%
3/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Vascular disorders
Haemodynamic instability
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Vascular disorders
Hypotension
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Vascular disorders
Shock
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
Other adverse events
| Measure |
Voluven® Arm
n=31 participants at risk
6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
|
HSA 5% Arm (Comparison Group)
n=29 participants at risk
Human Serum Albumin (HSA) 50g/L, i.v.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.5%
2/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
6.9%
2/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
6.9%
2/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Cardiac disorders
Bradycardia
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Cardiac disorders
Cardiac aneurysm
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Cardiac disorders
Nodal rhythm
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Cardiac disorders
Pericardial effusion
|
16.1%
5/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
10.3%
3/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Gastrointestinal disorders
Ascites
|
12.9%
4/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Gastrointestinal disorders
Constipation
|
22.6%
7/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
13.8%
4/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Gastrointestinal disorders
Dyspepsia
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Gastrointestinal disorders
Vomiting
|
41.9%
13/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
31.0%
9/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
General disorders
Device occlusion
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
10.3%
3/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
General disorders
Exposure to contaminated device
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
General disorders
Impaired healing
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
General disorders
Infusion site extravasation
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
General disorders
Infusion site urticaria
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
General disorders
Pyrexia
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
General disorders
Systemic inflammatory response syndrome
|
6.5%
2/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Aspergillosis
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Device related infection
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
H1n1 Influenza
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Influenza
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Laryngitis
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
13.8%
4/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Lung infection
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Pneumonia
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
6.9%
2/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Post procedural pneumonia
|
6.5%
2/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Postoperative wound infection
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Sepsis
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Infections and infestations
Skin candida
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Injury, poisoning and procedural complications
Dilutional coagulopathy
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
6.9%
2/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
6.5%
2/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
22.6%
7/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
20.7%
6/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Injury, poisoning and procedural complications
Wound
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Investigations
Aspartate aminotransferase increased
|
19.4%
6/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
13.8%
4/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Investigations
Blood lactic acid increased
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Investigations
Blood urea increased
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Investigations
Enterovirus test positive
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Investigations
Oxygen saturation decreased
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Investigations
Venous oxygen saturation decreased
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
54.8%
17/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
44.8%
13/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Metabolism and nutrition disorders
Hyperlactacidaemia
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
6.9%
2/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.5%
2/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
12.9%
4/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
6.9%
2/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.9%
4/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
20.7%
6/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.7%
3/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
10.3%
3/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
32.3%
10/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
6.5%
2/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
13.8%
4/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
25.8%
8/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
27.6%
8/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Nervous system disorders
Headache
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Nervous system disorders
Phrenic nerve paralysis
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Psychiatric disorders
Agitation
|
19.4%
6/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
10.3%
3/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Renal and urinary disorders
Anuria
|
6.5%
2/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
6.9%
2/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Renal and urinary disorders
Oliguria
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Renal and urinary disorders
Urinary retention
|
6.5%
2/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
6.9%
2/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnoea
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Reproductive system and breast disorders
Bronchospasm
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
6.9%
2/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
6.9%
2/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
22.6%
7/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.5%
2/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
6.9%
2/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
6.5%
2/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
6.9%
2/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
6.9%
2/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
2/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.2%
1/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
0.00%
0/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Vascular disorders
Arterial thrombosis limb
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
3.4%
1/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Vascular disorders
Haemodynamic instability
|
12.9%
4/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
13.8%
4/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
|
Vascular disorders
Hypotension
|
32.3%
10/31 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
13.8%
4/29 • Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Regular assessment by Pharmacovigilance and Safety Assessor
|
Additional Information
Professor Dr. Martin Westphal, Chief Medical Officer
Fresenius Kabi Aktiengesellschaft, Else-Kröner-Str. 1, 61352 Bad Homburg, Germany
Phone: +49 6172 686 7280
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publications are subject to a prior review of Fresenius Kabi and may only be made in a neutral and anonymous form within the respective circles of experts. Fresenius Kabi shall give its comments, if applicable, within 30 days after having received the respective manuscript. Manuscripts should be submitted for publication within 2 years following the final report.
- Publication restrictions are in place
Restriction type: OTHER