Trial Outcomes & Findings for Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding (NCT NCT00184548)
NCT ID: NCT00184548
Last Updated: 2014-06-25
Results Overview
Number of participants to die from day 0 to day 30 from all causes.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
554 participants
Primary outcome timeframe
from day 0 to 30
Results posted on
2014-06-25
Participant Flow
150 trial sites globally.
Eligible subjects were those with either blunt and/or penetrating trauma injuries and confirmed clinical indicators for active haemorrhage refractory to standard treatment (including blood component therapy and surgical haemostatic procedures).
Participant milestones
| Measure |
rFVIIa, Blunt Trauma
Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
|
Placebo, Blunt Trauma
Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
|
rVIIa, Penetrating Trauma
Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
|
Placebo, Penetrating Trauma
Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
226
|
255
|
47
|
45
|
|
Overall Study
Exposed
|
224
|
250
|
46
|
40
|
|
Overall Study
COMPLETED
|
218
|
242
|
44
|
38
|
|
Overall Study
NOT COMPLETED
|
8
|
13
|
3
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding
Baseline characteristics by cohort
| Measure |
rFVIIa, Blunt Trauma
n=221 Participants
|
Placebo, Blunt Trauma
n=247 Participants
|
rFVIIa, Penetrating Trauma
n=46 Participants
|
Placebo, Penetrating Trauma
n=40 Participants
|
Total
n=554 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
33.8 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
29.4 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
38.4 years
STANDARD_DEVIATION 14.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
162 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
424 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: from day 0 to 30Population: Blunt trauma patient population: Intention-to-treat (ITT) analysis set. Patients who discontinued (withdrawn or lost to follow up) before day 30 were excluded from analyses. Penetrating Trauma patient population: No analysis done due to low statistical power.
Number of participants to die from day 0 to day 30 from all causes.
Outcome measures
| Measure |
rFVIIa, Blunt Trauma
n=218 Participants
|
Placebo, Blunt Trauma
n=242 Participants
|
rFVIIa, Penetrating Trauma
|
Placebo, Penetrating Trauma
|
|---|---|---|---|---|
|
Mortality
|
24 Participants
|
26 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: from day 0 to day 30Population: Blunt trauma patient population: According to protocol, morbidity is not part of the primary endpoint since non-inferiority test of mortality was not passed. Penetrating Trauma patient population: No analysis done due to low statistical power.
Morbidity reflects the number of patients who had pulmonary and/or renal dysfunction requiring ongoing medical intervention on day 30.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from day 0 to day 30Population: Blunt trauma patient population: Intention-to-treat (ITT) analysis set. Penetrating Trauma patient population: No analysis done due to low statistical power.
The number of days alive and free of pulmonary and/or renal dysfunction requiring medical intervention from day 0 to day 30.
Outcome measures
| Measure |
rFVIIa, Blunt Trauma
n=218 Participants
|
Placebo, Blunt Trauma
n=242 Participants
|
rFVIIa, Penetrating Trauma
|
Placebo, Penetrating Trauma
|
|---|---|---|---|---|
|
Number of Days Alive and Free of Pulmonary and/or Renal Dysfunction Requiring Medical Intervention
|
17.2 Days
Standard Deviation 10.3
|
16.4 Days
Standard Deviation 10.3
|
—
|
—
|
SECONDARY outcome
Timeframe: from day 0 to day 30Population: There is no measure summary for time to event type of endpoint as this would be a Kaplan-Meier graph.
The time of first dose refers to the time of the first dose of rFVIIa or placebo.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from hour 0 to 24Population: Blunt trauma patient population: Intention-to-treat (ITT) analysis set including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power.
The number of units of transfused red blood cells in the first 24 hours from the time of the first dose of rFVIIa or placebo.
Outcome measures
| Measure |
rFVIIa, Blunt Trauma
n=221 Participants
|
Placebo, Blunt Trauma
n=247 Participants
|
rFVIIa, Penetrating Trauma
|
Placebo, Penetrating Trauma
|
|---|---|---|---|---|
|
Number of Units of Transfused Red Blood Cells From Time of First Dose
|
6.9 Units of transfused red blood cells
Standard Deviation 10.4
|
8.1 Units of transfused red blood cells
Standard Deviation 10.9
|
—
|
—
|
SECONDARY outcome
Timeframe: from hour 0 to 24Population: Blunt trauma patient population: Intention-to-treat (ITT) analysis set including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power.
The number of patients receiving 10 units or more of red blood cells in the first 24 hours from the time of injury.
Outcome measures
| Measure |
rFVIIa, Blunt Trauma
n=221 Participants
|
Placebo, Blunt Trauma
n=247 Participants
|
rFVIIa, Penetrating Trauma
|
Placebo, Penetrating Trauma
|
|---|---|---|---|---|
|
Number of Patients Receiving 10 Units or More (Massive Transfusion) of Red Blood Cells From Time of Injury
|
111 Participants
|
134 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: from hour 0 to 24Population: Blunt trauma patient population: Intention-to-treat (ITT) analysis set, including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power.
The number of units of all allogeneic transfusions in the first 24 hours from the time of the first dose of rFVIIa or placebo.
Outcome measures
| Measure |
rFVIIa, Blunt Trauma
n=221 Participants
|
Placebo, Blunt Trauma
n=247 Participants
|
rFVIIa, Penetrating Trauma
|
Placebo, Penetrating Trauma
|
|---|---|---|---|---|
|
Number of Units of All Allogeneic Transfusions From Time of First Dose
|
17.1 Units of allogeneic transfusions
Standard Deviation 26.8
|
20.7 Units of allogeneic transfusions
Standard Deviation 25.7
|
—
|
—
|
Adverse Events
rFVIIa, Blunt Trauma
Serious events: 147 serious events
Other events: 108 other events
Deaths: 0 deaths
Placebo, Blunt Trauma
Serious events: 177 serious events
Other events: 125 other events
Deaths: 0 deaths
rVIIa, Penetrating Trauma
Serious events: 18 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo, Penetrating Trauma
Serious events: 20 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rFVIIa, Blunt Trauma
n=224 participants at risk
Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
|
Placebo, Blunt Trauma
n=250 participants at risk
Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
|
rVIIa, Penetrating Trauma
n=46 participants at risk
Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
|
Placebo, Penetrating Trauma
n=40 participants at risk
Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Constipation
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Duodenal fistula
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
2.7%
6/224 • Number of events 6 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
3.2%
8/250 • Number of events 8 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
3/224 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Cardiac disorders
Cardiac arrest
|
3.1%
7/224 • Number of events 10 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
3.2%
8/250 • Number of events 9 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
4.3%
2/46 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Cardiac disorders
Cardiac failure
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Cardiac disorders
Cyanosis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Cardiac disorders
Electromechanical dissociation
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Cardiac disorders
Myocardial infarction
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
1.6%
4/250 • Number of events 5 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Endocrine disorders
Hyperadrenalism
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Eye disorders
Diplopia
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Abdominal compartment syndrome
|
2.2%
5/224 • Number of events 5 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.8%
7/250 • Number of events 7 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.8%
4/224 • Number of events 5 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Ileus
|
1.3%
3/224 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
1.2%
3/250 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.4%
6/250 • Number of events 6 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Peritoneal effusion
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
General disorders
Brain death
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
General disorders
Extravasation
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
General disorders
Impaired healing
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
General disorders
Multi-organ failure
|
4.5%
10/224 • Number of events 10 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
6.8%
17/250 • Number of events 18 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
General disorders
Pyrexia
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
1.6%
4/250 • Number of events 4 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
General disorders
Ulcer
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
General disorders
Wound necrosis
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Hepatobiliary disorders
Hepatic ischaemia
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Hepatobiliary disorders
Jaundice
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Immune system disorders
Anaphylactic reaction
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Immune system disorders
Hypersensitivity
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Abdominal abscess
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Abscess
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Abscess limb
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Acinetobacter infection
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Bacteraemia
|
1.3%
3/224 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
1.2%
3/250 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Bacterial sepsis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Bronchopneumonia
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Cellulitis
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Clostridial infection
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Empyema
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Enterococcal infection
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Haematoma infection
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Hepatic infection
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Incision site infection
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Infection
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Localised infection
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Meningitis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Pelvic infection
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Pneumonia
|
4.9%
11/224 • Number of events 11 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
10.4%
26/250 • Number of events 27 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
6.5%
3/46 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Arteriovenous fistula
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Post procedural sepsis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Postoperative wound infection
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
1.2%
3/250 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Pulmonary sepsis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Pyelonephritis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Respiratory tract infection
|
1.3%
3/224 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Sepsis
|
10.7%
24/224 • Number of events 24 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
12.0%
30/250 • Number of events 30 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
6.5%
3/46 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Septic necrosis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Septic shock
|
2.2%
5/224 • Number of events 5 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
4.8%
12/250 • Number of events 12 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Sinusitis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Skin graft infection
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Soft tissue infection
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Splenic abscess
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Staphylococcal infection
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Subcutaneous abscess
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Superinfection
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Systemic candida
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
4/224 • Number of events 4 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.0%
5/250 • Number of events 5 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Urosepsis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Wound abscess
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Wound infection
|
3.1%
7/224 • Number of events 8 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
4.0%
10/250 • Number of events 10 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Wound infection bacterial
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Wound infection pseudomonas
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Infections and infestations
Wound sepsis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Device failure
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Diffuse axonal injury
|
1.3%
3/224 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Failure to anastomose
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Fat embolism
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Hepatic haematoma
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Iatrogenic injury
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Inadequate analgesia
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Urinary bladder rupture
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Circulatory collapse
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Vena cava injury
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Vertebral injury
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Weaning failure
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Wound decomposition
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Investigations
Cardiac output decreased
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Investigations
Sputum culture positive
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Investigations
Transaminases increased
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.3%
3/224 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
1.6%
4/250 • Number of events 5 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Musculoskeletal and connective tissue disorders
Muscle necrosis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Musculoskeletal and connective tissue disorders
Pelvic deformity
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebral hygroma
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Anoxic encephalopathy
|
1.3%
3/224 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Cerebellar infarction
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Cerebral infarction
|
1.3%
3/224 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.0%
5/250 • Number of events 5 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Convulsion
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Critical illness polyneuropathy
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Hemiparesis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Hydrocephalus
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Neuralgia
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Neuromyopathy
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Quadriparesis
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Subdural effusion
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Syncope vasovagal
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Renal and urinary disorders
Anuria
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Renal and urinary disorders
Renal failure
|
1.3%
3/224 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
1.2%
3/250 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
4.3%
2/46 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Renal and urinary disorders
Renal failure acute
|
1.8%
4/224 • Number of events 4 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.4%
6/250 • Number of events 6 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Renal and urinary disorders
Renal impairment
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Renal and urinary disorders
Urinary fistula
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Reproductive system and breast disorders
Pelvic haemorrhage
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
3.6%
8/224 • Number of events 8 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
7.2%
18/250 • Number of events 18 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
7.5%
3/40 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
5/224 • Number of events 5 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
1.6%
4/250 • Number of events 4 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.7%
6/224 • Number of events 6 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
4.3%
2/46 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.0%
9/224 • Number of events 10 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.8%
7/250 • Number of events 7 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
1.2%
3/250 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.3%
3/224 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.1%
7/224 • Number of events 7 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.4%
6/250 • Number of events 6 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.8%
4/224 • Number of events 4 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Surgical and medical procedures
Internal fixation of fracture
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Surgical and medical procedures
Leg amputation
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Arterial haemorrhage
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Arterial thrombosis limb
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Deep vein thrombosis
|
6.2%
14/224 • Number of events 14 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.6%
14/250 • Number of events 14 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Embolism
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Exsanguination
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Haematoma
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Haemodynamic instability
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Haemorrhage
|
2.2%
5/224 • Number of events 5 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.0%
5/250 • Number of events 5 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
1.2%
3/250 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Ischaemia
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Peripheral artery dissection
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Peripheral ischaemia
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Shock
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.80%
2/250 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Shock haemorrhagic
|
1.3%
3/224 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.4%
6/250 • Number of events 6 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Vena cava thrombosis
|
0.89%
2/224 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Venous haemorrhage
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Venous thrombosis
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Venous thrombosis limb
|
0.45%
1/224 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.40%
1/250 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
Other adverse events
| Measure |
rFVIIa, Blunt Trauma
n=224 participants at risk
Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
|
Placebo, Blunt Trauma
n=250 participants at risk
Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
|
rVIIa, Penetrating Trauma
n=46 participants at risk
Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
|
Placebo, Penetrating Trauma
n=40 participants at risk
Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
9/224 • Number of events 10 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.2%
13/250 • Number of events 14 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.5%
10/224 • Number of events 10 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
6.0%
15/250 • Number of events 15 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
6.5%
3/46 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.5%
1/40 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Cardiac disorders
Tachycardia
|
5.4%
12/224 • Number of events 12 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.2%
13/250 • Number of events 14 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
13.0%
6/46 • Number of events 6 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
General disorders
Hyperthermia
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
6.5%
3/46 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
General disorders
Hypothermia
|
6.7%
15/224 • Number of events 15 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
8.4%
21/250 • Number of events 22 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
General disorders
Pain
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
General disorders
Pyrexia
|
12.1%
27/224 • Number of events 27 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
10.8%
27/250 • Number of events 29 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
23.9%
11/46 • Number of events 11 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
35.0%
14/40 • Number of events 14 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
6.5%
3/46 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
7.5%
3/40 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.4%
12/224 • Number of events 12 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
6.8%
17/250 • Number of events 17 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
10.0%
4/40 • Number of events 4 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.2%
25/224 • Number of events 25 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
12.0%
30/250 • Number of events 30 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
8.7%
4/46 • Number of events 4 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
7.5%
3/40 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
28/224 • Number of events 28 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
12.8%
32/250 • Number of events 33 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
10.9%
5/46 • Number of events 5 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
7.5%
3/40 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.4%
21/224 • Number of events 21 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
11.2%
28/250 • Number of events 28 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
10.9%
5/46 • Number of events 5 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
12.5%
5/40 • Number of events 5 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.7%
6/224 • Number of events 6 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.6%
14/250 • Number of events 14 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
8.7%
4/46 • Number of events 4 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.0%
2/40 • Number of events 2 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Renal and urinary disorders
Oliguria
|
4.0%
9/224 • Number of events 11 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
5.6%
14/250 • Number of events 14 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/46 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/40 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/224 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
0.00%
0/250 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
10.9%
5/46 • Number of events 5 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
7.5%
3/40 • Number of events 3 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
|
Vascular disorders
Hypotension
|
10.7%
24/224 • Number of events 24 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
10.0%
25/250 • Number of events 26 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
8.7%
4/46 • Number of events 4 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
10.0%
4/40 • Number of events 4 • Adverse events were collected in a timespan of 90 days.
Safety population includes three patients in each blunt trauma treatment arm who were randomised received an initial dose and no further information is known. These patients were not included in the intent-to-treat (ITT) population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk acknowledges the Investigator's right to publish the entire results of the trial in accordance with the latest Vancouver guidelines. Any such scientific paper, resentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication / presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
- Publication restrictions are in place
Restriction type: OTHER