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Trial Outcomes & Findings for Adjusted Fibrinogen Replacement Strategy (NCT NCT03444324)

NCT ID: NCT03444324

Last Updated: 2025-06-13

Results Overview

Intra-operative blood loss as measured by amount of blood from blood suction unit and amount of blood from surgical cloths and compresses.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

222 participants

Primary outcome timeframe

From decision to treat the subject with IMP until end of surgery, an average of 5 hours

Results posted on

2025-06-13

Participant Flow

339 subjects were screened, of these 222 subjects were eligible for the study and randomized. Baseline characteristics are available for the 222 randomized subjects.

There were 117 screen failures due to the following reasons: Eligibility criteria not met (before surgery), n=11; Intra-operative eligibility criterion not met, n=69; Physician decision, n=21; Adverse event, n=2; Withdrawal by subject, n=10; Technical reason, n=3; Other, n=1. Subjects eligible for randomization: n=222.

Participant milestones

Participant milestones
Measure
BT524
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
FFP/Cryo
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards. FFP, 15 mL per kg body weight (BW); Cryo, fixed dose of 10 units.
Overall Study
STARTED
110
112
Overall Study
COMPLETED
105
106
Overall Study
NOT COMPLETED
5
6

Reasons for withdrawal

Reasons for withdrawal
Measure
BT524
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
FFP/Cryo
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards. FFP, 15 mL per kg body weight (BW); Cryo, fixed dose of 10 units.
Overall Study
Withdrawal by Subject
0
1
Overall Study
Lost to Follow-up
4
2
Overall Study
Protocol Violation
0
1
Overall Study
Lack of Trial Compliance
1
1
Overall Study
Physical disability to come to the site for the closing visit
0
1

Baseline Characteristics

Adjusted Fibrinogen Replacement Strategy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
BT524
n=110 Participants
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
FFP/Cryo
n=112 Participants
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards. FFP, 15 mL per kg BW; Cryo, fixed dose of 10 units.
Total
n=222 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
62 Participants
n=99 Participants
58 Participants
n=107 Participants
120 Participants
n=206 Participants
Age, Categorical
>=65 years
48 Participants
n=99 Participants
54 Participants
n=107 Participants
102 Participants
n=206 Participants
Age, Continuous
61.2 years
STANDARD_DEVIATION 12.52 • n=99 Participants
60.8 years
STANDARD_DEVIATION 14.07 • n=107 Participants
61.0 years
STANDARD_DEVIATION 13.29 • n=206 Participants
Sex: Female, Male
Female
67 Participants
n=99 Participants
64 Participants
n=107 Participants
131 Participants
n=206 Participants
Sex: Female, Male
Male
43 Participants
n=99 Participants
48 Participants
n=107 Participants
91 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
n=99 Participants
6 Participants
n=107 Participants
12 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
103 Participants
n=99 Participants
106 Participants
n=107 Participants
209 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
1 Participants
n=99 Participants
2 Participants
n=107 Participants
3 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
White
109 Participants
n=99 Participants
107 Participants
n=107 Participants
216 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Region of Enrollment
Czechia
28 participants
n=99 Participants
30 participants
n=107 Participants
58 participants
n=206 Participants
Region of Enrollment
Poland
0 participants
n=99 Participants
1 participants
n=107 Participants
1 participants
n=206 Participants
Region of Enrollment
United Kingdom
48 participants
n=99 Participants
50 participants
n=107 Participants
98 participants
n=206 Participants
Region of Enrollment
Switzerland
9 participants
n=99 Participants
9 participants
n=107 Participants
18 participants
n=206 Participants
Region of Enrollment
Germany
14 participants
n=99 Participants
9 participants
n=107 Participants
23 participants
n=206 Participants
Region of Enrollment
Spain
11 participants
n=99 Participants
13 participants
n=107 Participants
24 participants
n=206 Participants
Expected Blood Loss
>1000 mL to <=2000 mL
44 participants
n=99 Participants
48 participants
n=107 Participants
92 participants
n=206 Participants
Expected Blood Loss
>2000 mL
66 participants
n=99 Participants
64 participants
n=107 Participants
130 participants
n=206 Participants

PRIMARY outcome

Timeframe: From decision to treat the subject with IMP until end of surgery, an average of 5 hours

Population: Per-protocol set (PPS): All randomized subjects receiving IMP post randomization and with data collected post randomization. Subjects who were compliant with the trial protocol without any major protocol deviations thought to have the potential to impact the results of the efficacy analysis, e.g., no treatment or incomplete treatment with study intervention (BT524 or FFP/Cryo) during surgery, no postdose efficacy assessment for the primary endpoint.

Intra-operative blood loss as measured by amount of blood from blood suction unit and amount of blood from surgical cloths and compresses.

Outcome measures

Outcome measures
Measure
BT524
n=103 Participants
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
n=98 Participants
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards.
Intra-operative Blood Loss
1380.7 mL
Interval 1187.09 to 1574.31
1660.13 mL
Interval 1460.65 to 1859.61

SECONDARY outcome

Timeframe: Prior first dose, 15 minutes after start of first IMP administration

Population: Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized.

Successful correction of the fibrinogen level is defined as restoring fibrinogen FIBTEM A10 baseline (prior surgery) levels measured by ROTEM (thromboelastometry) 15 minutes after start of first IMP administration

Outcome measures

Outcome measures
Measure
BT524
n=104 Participants
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
n=102 Participants
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards.
Proportion (%) of Subjects With Successful Correction of Fibrinogen Level (FIBTEM A10) 15 Minutes After Start of First IMP Administration
59 Participants
19 Participants

SECONDARY outcome

Timeframe: prior 1st dose, pre-dose, 15 minutes and 90 minutes after start of first IMP administration, end of surgery

Population: Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized.

Correction of the fibrinogen level, measured via thromboelastometry (ROTEM/FIBTEM A10), within 15 minutes after IMP start, between 15 and 90 minutes after IMP start, after 90 minutes after IMP start, or unsuccessful correction. The 4 categories were compared between the two treatment arms using a Chi-square test.

Outcome measures

Outcome measures
Measure
BT524
n=107 Participants
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
n=104 Participants
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards.
Time to First Successful Correction of Fibrinogen Level
<=15 minutes after IMP start
59 Participants
19 Participants
Time to First Successful Correction of Fibrinogen Level
>15 and <= 90 minutes after IMP start
17 Participants
11 Participants
Time to First Successful Correction of Fibrinogen Level
>90 minutes after IMP start
11 Participants
16 Participants
Time to First Successful Correction of Fibrinogen Level
Unsuccessful correction
20 Participants
58 Participants

SECONDARY outcome

Timeframe: After start of first IMP administration until end of surgery, an average of 5 hours

Population: Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized.

Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

Outcome measures

Outcome measures
Measure
BT524
n=107 Participants
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
n=104 Participants
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards.
Transfusion Requirements: Cell Salvage
95.6 mL
Standard Deviation 244.57
78.0 mL
Standard Deviation 234.77

SECONDARY outcome

Timeframe: After start of first IMP administration until end of surgery, an average of 5 hours

Population: Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized.

Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

Outcome measures

Outcome measures
Measure
BT524
n=107 Participants
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
n=104 Participants
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards.
Transfusion Requirements: Allogeneic Platelets
3.0 mL
Standard Deviation 30.94
3.6 mL
Standard Deviation 36.38

SECONDARY outcome

Timeframe: After start of first IMP administration until end of surgery, an average of 5 hours

Population: Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized.

Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

Outcome measures

Outcome measures
Measure
BT524
n=107 Participants
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
n=104 Participants
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards.
Transfusion Requirements: Allogeneic Red Blood Cells
455.5 mL
Standard Deviation 492.19
488.4 mL
Standard Deviation 547.72

SECONDARY outcome

Timeframe: After start of first IMP administration until end of surgery, an average of 5 hours

Population: Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized.

Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

Outcome measures

Outcome measures
Measure
BT524
n=107 Participants
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
n=104 Participants
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards.
Transfusion Requirements: Fresh Frozen Plasma
60.5 mL
Standard Deviation 217.68
14.8 mL
Standard Deviation 110.94

SECONDARY outcome

Timeframe: After start of first IMP administration until end of surgery, an average of 5 hours

Population: Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized.

Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

Outcome measures

Outcome measures
Measure
BT524
n=107 Participants
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
n=104 Participants
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards.
Transfusion Requirements, Cryoprecipitate
0 mL
Standard Deviation 0
0 mL
Standard Deviation 0

SECONDARY outcome

Timeframe: After start of first IMP administration until end of surgery, an average of 5 hours

Population: Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized.

Amount (volume) of RBCs (allogenic and autologous RBCs) infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture.

Outcome measures

Outcome measures
Measure
BT524
n=107 Participants
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
n=104 Participants
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards.
Amount of Red Blood Cells (RBCs)
543.4 mL
Interval 441.99 to 644.77
558.9 mL
Interval 456.08 to 661.62

SECONDARY outcome

Timeframe: From end of surgery (time of last suture) up to 24 hours after the end of surgery

Population: Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized.

Post-operative drainage volume in the first 24 hours after end of surgery

Outcome measures

Outcome measures
Measure
BT524
n=107 Participants
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
n=104 Participants
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards.
Post-operative Blood Loss
306.3 mL
Interval 234.15 to 378.38
293.9 mL
Interval 220.76 to 366.95

SECONDARY outcome

Timeframe: End of surgery up to 8 days after surgery

Population: Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized.

Proportion (%) of subjects with rebleeds after the end of surgery until day 8

Outcome measures

Outcome measures
Measure
BT524
n=107 Participants
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
n=104 Participants
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards.
Subjects With Rebleeds
0 Participants
5 Participants

SECONDARY outcome

Timeframe: From day of surgery until day of hospital discharge, an average of 16 days (up to 56 days)

Population: Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized.

Length of stay after surgery (days) = 'date of hospital discharge' minus 'date of surgery'. Where date of discharge is the date of discharge following the IMP treated surgery.

Outcome measures

Outcome measures
Measure
BT524
n=107 Participants
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
n=104 Participants
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards.
Hospital Length of Stay After Surgery
>36 days
7 Participants
4 Participants
Hospital Length of Stay After Surgery
29-36 days
4 Participants
10 Participants
Hospital Length of Stay After Surgery
22-28 days
13 Participants
12 Participants
Hospital Length of Stay After Surgery
15-21 days
34 Participants
17 Participants
Hospital Length of Stay After Surgery
8-14 days
39 Participants
49 Participants
Hospital Length of Stay After Surgery
1-7 days
10 Participants
12 Participants

SECONDARY outcome

Timeframe: From day of surgery until day of hospital discharge, an average of 16 days (up to 56 days)

Population: Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized.

Number and percentages of subjects who died during hospital stay

Outcome measures

Outcome measures
Measure
BT524
n=107 Participants
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
n=104 Participants
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards.
In-hospital Mortality
0 Participants
0 Participants

SECONDARY outcome

Timeframe: From day of surgery until closing visit (up to 181 days)

Population: Safety Analysis Set (SAF): All subjects who have received at least one dose of IMP.

Total number of subjects with thrombosis or TEEs documented as treatment-emergent adverse events of special interest

Outcome measures

Outcome measures
Measure
BT524
n=110 Participants
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
n=112 Participants
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards.
Number of Subjects With Thrombosis or Thromboembolic Events (TEEs)
8 Participants
13 Participants

SECONDARY outcome

Timeframe: Screening visit (up to 42 days prior to surgery) and closing visit (up to 181 days after surgery)

Population: Safety Analysis Set (SAF): All subjects who have received at least one dose of IMP.

Number of subjects with change in status of viral infections

Outcome measures

Outcome measures
Measure
BT524
n=110 Participants
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
n=112 Participants
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards.
Change in Viral Status
0 Participants
0 Participants

Adverse Events

BT524

Serious events: 28 serious events
Other events: 92 other events
Deaths: 0 deaths

Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)

Serious events: 41 serious events
Other events: 93 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
BT524
n=110 participants at risk
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
n=112 participants at risk
Standard of Care FFP/Cryo: FFP/Cryo was administered intravenously; dosage according to local standards.
Vascular disorders
Deep vein thrombosis
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
2.7%
3/112 • Number of events 3 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Vascular disorders
Hypovolaemic shock
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 3 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Vascular disorders
Neurogenic shock
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Vascular disorders
Phlebitis
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Vascular disorders
Shock haemorrhagic
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
General disorders
Impaired healing
1.8%
2/110 • Number of events 2 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
General disorders
Chest pain
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
General disorders
Pain
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
General disorders
Surgical failure
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Immune system disorders
Anaphylactic reaction
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
2.7%
3/110 • Number of events 3 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
6.2%
7/112 • Number of events 7 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Injury, poisoning and procedural complications
Seroma
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
2.7%
3/112 • Number of events 3 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Injury, poisoning and procedural complications
Anaemia postoperative
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
2.7%
3/112 • Number of events 3 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Injury, poisoning and procedural complications
Dural tear
2.7%
3/110 • Number of events 3 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Injury, poisoning and procedural complications
Wound dehiscence
1.8%
2/110 • Number of events 2 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Injury, poisoning and procedural complications
Procedural pain
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Injury, poisoning and procedural complications
Bladder injuryI
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Injury, poisoning and procedural complications
Craniocerebral injury
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Injury, poisoning and procedural complications
Post procedural complication
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Injury, poisoning and procedural complications
Post procedural haematoma
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Injury, poisoning and procedural complications
Postoperative wound complication
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Injury, poisoning and procedural complications
Procedural haemorrhage
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Injury, poisoning and procedural complications
Stoma site haemorrhage
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Injury, poisoning and procedural complications
Wound haematoma
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Cardiac disorders
Acute coronary syndrome
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Cardiac disorders
Atrial fibrillation
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Cardiac disorders
Atrial flutter
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Nervous system disorders
Cerebrospinal fluid leakage
1.8%
2/110 • Number of events 2 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Nervous system disorders
Paraparesis
1.8%
2/110 • Number of events 2 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Nervous system disorders
Loss of consciousness
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Nervous system disorders
Paraplegia
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Nervous system disorders
Presyncope
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Nervous system disorders
Sciatica
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Blood and lymphatic system disorders
Anaemia
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
1.8%
2/112 • Number of events 2 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Blood and lymphatic system disorders
Haemorrhagic diathesis
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Blood and lymphatic system disorders
Thrombocytopenia
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Gastrointestinal disorders
Constipation
1.8%
2/110 • Number of events 2 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
1.8%
2/112 • Number of events 2 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Gastrointestinal disorders
Intestinal obstruction
1.8%
2/110 • Number of events 2 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Gastrointestinal disorders
Vomiting
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Gastrointestinal disorders
Gastric perforation
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Gastrointestinal disorders
Ileal perforation
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Gastrointestinal disorders
Ileus paralytic
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Gastrointestinal disorders
Inguinal hernia strangulated
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Gastrointestinal disorders
Nausea
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Skin and subcutaneous tissue disorders
Decubitus ulcer
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Renal and urinary disorders
Acute kidney injury
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Musculoskeletal and connective tissue disorders
Pathological fracture
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Infections and infestations
Postoperative wound infection
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
2.7%
3/112 • Number of events 3 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Infections and infestations
Wound infection
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
1.8%
2/112 • Number of events 3 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Infections and infestations
Lower respiratory tract infection
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Infections and infestations
Meningitis bacterial
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Infections and infestations
Pneumonia
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Infections and infestations
Post procedural infection
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Infections and infestations
Soft tissue infection
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Infections and infestations
Urinary tract infection
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Metabolism and nutrition disorders
Dehydration
0.00%
0/110 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.89%
1/112 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Metabolism and nutrition disorders
Hypercalcaemia
0.91%
1/110 • Number of events 1 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
0.00%
0/112 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.

Other adverse events

Other adverse events
Measure
BT524
n=110 participants at risk
Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)
n=112 participants at risk
Standard of Care FFP/Cryo: FFP/Cryo was administered intravenously; dosage according to local standards.
Investigations
Gamma-glutamyltransferase increased
4.5%
5/110 • Number of events 5 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
7.1%
8/112 • Number of events 8 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Investigations
Oxygen saturation decreased
1.8%
2/110 • Number of events 2 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
6.2%
7/112 • Number of events 8 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Injury, poisoning and procedural complications
Anaemia postoperative
13.6%
15/110 • Number of events 15 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
5.4%
6/112 • Number of events 6 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Vascular disorders
Hypotension
20.9%
23/110 • Number of events 29 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
8.9%
10/112 • Number of events 14 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Cardiac disorders
Tachycardia
17.3%
19/110 • Number of events 22 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
12.5%
14/112 • Number of events 14 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Gastrointestinal disorders
Constipation
5.5%
6/110 • Number of events 6 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
1.8%
2/112 • Number of events 2 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Gastrointestinal disorders
Nausea
9.1%
10/110 • Number of events 11 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
3.6%
4/112 • Number of events 4 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Hepatobiliary disorders
Hypertransaminasaemia
11.8%
13/110 • Number of events 13 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
9.8%
11/112 • Number of events 11 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
3.6%
4/110 • Number of events 5 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
5.4%
6/112 • Number of events 6 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Psychiatric disorders
Hallucination
26.4%
29/110 • Number of events 30 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
23.2%
26/112 • Number of events 26 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Infections and infestations
Pneumonia
9.1%
10/110 • Number of events 10 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
8.9%
10/112 • Number of events 10 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Infections and infestations
Urinary tract infection
9.1%
10/110 • Number of events 10 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
8.9%
10/112 • Number of events 10 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Metabolism and nutrition disorders
Hypokalaemia
4.5%
5/110 • Number of events 5 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
5.4%
6/112 • Number of events 7 • From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.

Additional Information

Dr. Christina Erb

Biotest AG

Phone: 00496103801

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place