Trial Outcomes & Findings for Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery (NCT NCT00914589)
NCT ID: NCT00914589
Last Updated: 2017-03-07
Results Overview
Proportion of patients avoiding blood products given via allogeneic transfusion. Blood products were defined as any of the following: RBC, platelets, FFP, fibrinogen concentrate and clotting factor(s) concentrate, including cryoprecipitate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
479 participants
Primary outcome timeframe
measured ongoing from dosing until day 7 or discharge, whichever came first
Results posted on
2017-03-07
Participant Flow
Of a total of 32 initiated trial sites, 30 sites randomised and dosed at least one patient. The country distribution for these 30 sites was as follows (number of sites per country in parenthesis): Canada (5), Denmark (1), Germany (4), Great Britain (3), Israel (2), Italy (2), Japan (4), Spain (3) and the United States (6).
Seventy (70) of 479 subjects randomised in the trial were withdrawn before trial product administration.
Participant milestones
| Measure |
Placebo
Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII17.5IU/Kg
Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII35IU/Kg
Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
|---|---|---|---|
|
Overall Study
STARTED
|
128
|
143
|
138
|
|
Overall Study
COMPLETED
|
103
|
127
|
126
|
|
Overall Study
NOT COMPLETED
|
25
|
16
|
12
|
Reasons for withdrawal
| Measure |
Placebo
Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII17.5IU/Kg
Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII35IU/Kg
Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
8
|
6
|
3
|
|
Overall Study
unclassified
|
16
|
9
|
7
|
|
Overall Study
Death
|
0
|
1
|
1
|
Baseline Characteristics
Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery
Baseline characteristics by cohort
| Measure |
Placebo
n=128 Participants
Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII17.5IU/Kg
n=143 Participants
Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII35IU/Kg
n=138 Participants
Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
Total
n=409 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
68.7 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
69.0 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
68.8 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
336 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: measured ongoing from dosing until day 7 or discharge, whichever came firstPopulation: Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment.
Proportion of patients avoiding blood products given via allogeneic transfusion. Blood products were defined as any of the following: RBC, platelets, FFP, fibrinogen concentrate and clotting factor(s) concentrate, including cryoprecipitate.
Outcome measures
| Measure |
Placebo
n=128 Participants
Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII17.5IU/Kg
n=143 Participants
Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII35IU/Kg
n=138 Participants
Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
|---|---|---|---|
|
Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First
Transfused
|
35.2 percentage (%) of subjects
|
35.7 percentage (%) of subjects
|
34.1 percentage (%) of subjects
|
|
Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First
Not transfused
|
64.8 percentage (%) of subjects
|
64.3 percentage (%) of subjects
|
65.9 percentage (%) of subjects
|
SECONDARY outcome
Timeframe: measured from screening until 5-7 weeks post Trial Drug AdministrationPopulation: The safety analysis set included all subjects who were exposed to at least one dose of trial product.
Percentage of subjects with thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism) until end of trial
Outcome measures
| Measure |
Placebo
n=128 Participants
Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII17.5IU/Kg
n=143 Participants
Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII35IU/Kg
n=138 Participants
Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
|---|---|---|---|
|
Percentage of Subjects With Thromboembolic Events
All events
|
9.38 percentage of subjects
|
8.39 percentage of subjects
|
6.52 percentage of subjects
|
|
Percentage of Subjects With Thromboembolic Events
Peri-operative Acute Myocardial infarcti
|
6.25 percentage of subjects
|
6.99 percentage of subjects
|
5.07 percentage of subjects
|
|
Percentage of Subjects With Thromboembolic Events
Cerebrovascular Thromboembolic Event
|
2.34 percentage of subjects
|
1.40 percentage of subjects
|
0.00 percentage of subjects
|
|
Percentage of Subjects With Thromboembolic Events
Deep vein thrombosis
|
0.78 percentage of subjects
|
0.00 percentage of subjects
|
0.72 percentage of subjects
|
|
Percentage of Subjects With Thromboembolic Events
Peripheral Artery Occlusion
|
0.00 percentage of subjects
|
0.00 percentage of subjects
|
0.72 percentage of subjects
|
SECONDARY outcome
Timeframe: measured from screening until 5-7 weeks post Trial Drug AdministrationPopulation: Safety analysis set includes all subj. exposed to at least one dose of trial product. 1 subj with a low titre antibody at baseline was also reported with low titre FXIII antibody at visit 8. 27, 19 and 17 subjects in placebo, FXIII 17.5 and 35 IU/KG, respectively, did not have antibody measurement.
Immunogenicity as number of subjects who manifested FXIII antibody reaction until end of trial. The percentage may be derived from the number of subjects treated with rFXIII with available antibody measurement at visit 8.
Outcome measures
| Measure |
Placebo
n=101 Participants
Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII17.5IU/Kg
n=124 Participants
Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII35IU/Kg
n=121 Participants
Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
|---|---|---|---|
|
Percentage of Subjects With rFXIII Antibody Reaction
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: measured from screening until 5-7 weeks post Trial Drug AdministrationPopulation: The safety analysis set included all subjects who were exposed to at least one dose of trial product.
Percentage of subjects with critical adverse events (thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism), renal dysfunction, re-operation and death) until end of trial
Outcome measures
| Measure |
Placebo
n=128 Participants
Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII17.5IU/Kg
n=143 Participants
Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII35IU/Kg
n=138 Participants
Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
|---|---|---|---|
|
Percentage of Subjects With Critical Adverse Events
All events
|
14.84 percentage (%) of subjects
|
16.78 percentage (%) of subjects
|
11.59 percentage (%) of subjects
|
|
Percentage of Subjects With Critical Adverse Events
Peri-operative Acute Myocardial Infarcti
|
6.25 percentage (%) of subjects
|
6.99 percentage (%) of subjects
|
5.07 percentage (%) of subjects
|
|
Percentage of Subjects With Critical Adverse Events
Renal dysfunction
|
7.03 percentage (%) of subjects
|
6.99 percentage (%) of subjects
|
3.62 percentage (%) of subjects
|
|
Percentage of Subjects With Critical Adverse Events
Re-operation
|
1.56 percentage (%) of subjects
|
5.59 percentage (%) of subjects
|
2.90 percentage (%) of subjects
|
|
Percentage of Subjects With Critical Adverse Events
Cerebrovascular Thromboembolic Event
|
2.34 percentage (%) of subjects
|
1.40 percentage (%) of subjects
|
0.00 percentage (%) of subjects
|
|
Percentage of Subjects With Critical Adverse Events
Death
|
0.00 percentage (%) of subjects
|
0.70 percentage (%) of subjects
|
0.72 percentage (%) of subjects
|
|
Percentage of Subjects With Critical Adverse Events
Deep vein thrombosis
|
0.78 percentage (%) of subjects
|
0.00 percentage (%) of subjects
|
0.72 percentage (%) of subjects
|
|
Percentage of Subjects With Critical Adverse Events
Peripheral artery Occlusion
|
0.00 percentage (%) of subjects
|
0.00 percentage (%) of subjects
|
0.72 percentage (%) of subjects
|
SECONDARY outcome
Timeframe: measured from screening until 5-7 weeks post Trial Drug AdministrationPopulation: The safety analysis set included all subjects who were exposed to at least one dose of trial product.
Percentage of subjects with serious adverse events until end of trial.
Outcome measures
| Measure |
Placebo
n=128 Participants
Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII17.5IU/Kg
n=143 Participants
Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII35IU/Kg
n=138 Participants
Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
|---|---|---|---|
|
Percentage of Subjects With Serious Adverse Events
Blood and lymphatic system disorders
|
0.00 percentage (%) of subjects
|
0.70 percentage (%) of subjects
|
0.00 percentage (%) of subjects
|
|
Percentage of Subjects With Serious Adverse Events
Cardiac disorders
|
8.59 percentage (%) of subjects
|
12.59 percentage (%) of subjects
|
7.25 percentage (%) of subjects
|
|
Percentage of Subjects With Serious Adverse Events
Eye disorders
|
0.00 percentage (%) of subjects
|
0.70 percentage (%) of subjects
|
0.00 percentage (%) of subjects
|
|
Percentage of Subjects With Serious Adverse Events
Gastrointestinal disorders
|
1.56 percentage (%) of subjects
|
0.70 percentage (%) of subjects
|
0.00 percentage (%) of subjects
|
|
Percentage of Subjects With Serious Adverse Events
General disorders and administration sit
|
1.56 percentage (%) of subjects
|
0.00 percentage (%) of subjects
|
2.17 percentage (%) of subjects
|
|
Percentage of Subjects With Serious Adverse Events
Infections and infestations
|
5.47 percentage (%) of subjects
|
5.59 percentage (%) of subjects
|
3.62 percentage (%) of subjects
|
|
Percentage of Subjects With Serious Adverse Events
Injury, poisoning and procedural compli
|
2.34 percentage (%) of subjects
|
4.90 percentage (%) of subjects
|
2.90 percentage (%) of subjects
|
|
Percentage of Subjects With Serious Adverse Events
Investigations
|
0.00 percentage (%) of subjects
|
0.00 percentage (%) of subjects
|
0.72 percentage (%) of subjects
|
|
Percentage of Subjects With Serious Adverse Events
Musculoskeletal and connective tissue d
|
0.00 percentage (%) of subjects
|
0.70 percentage (%) of subjects
|
0.00 percentage (%) of subjects
|
|
Percentage of Subjects With Serious Adverse Events
Neoplasms benign, malignant and unspecif
|
0.78 percentage (%) of subjects
|
0.00 percentage (%) of subjects
|
0.00 percentage (%) of subjects
|
|
Percentage of Subjects With Serious Adverse Events
Nervous system disorders
|
3.91 percentage (%) of subjects
|
2.80 percentage (%) of subjects
|
2.17 percentage (%) of subjects
|
|
Percentage of Subjects With Serious Adverse Events
Psychiatric disorders
|
0.00 percentage (%) of subjects
|
0.70 percentage (%) of subjects
|
0.72 percentage (%) of subjects
|
|
Percentage of Subjects With Serious Adverse Events
Renal and urinary disorders
|
1.56 percentage (%) of subjects
|
2.10 percentage (%) of subjects
|
2.17 percentage (%) of subjects
|
|
Percentage of Subjects With Serious Adverse Events
Respiratory, thoracic and mediastinal d
|
7.03 percentage (%) of subjects
|
6.29 percentage (%) of subjects
|
7.25 percentage (%) of subjects
|
|
Percentage of Subjects With Serious Adverse Events
Skin and subcutaneous tissue disorders
|
0.78 percentage (%) of subjects
|
0.00 percentage (%) of subjects
|
0.00 percentage (%) of subjects
|
|
Percentage of Subjects With Serious Adverse Events
Vascular disorders
|
1.56 percentage (%) of subjects
|
1.40 percentage (%) of subjects
|
1.45 percentage (%) of subjects
|
Adverse Events
Placebo
Serious events: 35 serious events
Other events: 120 other events
Deaths: 0 deaths
FXIII17.5IU/Kg
Serious events: 43 serious events
Other events: 129 other events
Deaths: 0 deaths
FXIII35IU/Kg
Serious events: 32 serious events
Other events: 128 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=128 participants at risk
Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII17.5IU/Kg
n=143 participants at risk
Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII35IU/Kg
n=138 participants at risk
Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
2.1%
3/143 • Number of events 3 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
1.4%
2/143 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Atrial fibrillation
|
3.9%
5/128 • Number of events 5 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
2.1%
3/143 • Number of events 3 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
1.4%
2/138 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
2.2%
3/138 • Number of events 3 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Bradyarrhythmia
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
1.4%
2/143 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Cardiac failure
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
2.1%
3/143 • Number of events 3 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Cardiac tamponade
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
1.4%
2/143 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Dressler
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
2/128 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Pericarditis
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Tachyarrhythmia
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Tachycardia
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Eye disorders
Retinal ischaemia
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Gastrointestinal disorders
Peritonitis
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
General disorders
Chest pain
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
General disorders
Drug intolerance
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
General disorders
Impaired healing
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
1.4%
2/138 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Infections and infestations
Enterococcal infection
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Infections and infestations
Lung infection pseudomonal
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Infections and infestations
Pneumonia
|
1.6%
2/128 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Infections and infestations
Pneumonia klebsiella
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Infections and infestations
Postoperative wound infection
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Infections and infestations
Sepsis
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
1.4%
2/138 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Infections and infestations
Staphylococcal infection
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Infections and infestations
Wound infection
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
2.8%
4/143 • Number of events 4 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Infections and infestations
Wound infection bacterial
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Injury, poisoning and procedural complications
Graft dysfunction
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
1.4%
2/143 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.6%
2/128 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
1.4%
2/143 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure comp
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Injury, poisoning and procedural complications
Postpericardiotomy syndrome
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Nervous system disorders
Cerebrovascular accident
|
1.6%
2/128 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Nervous system disorders
Convulsion
|
1.6%
2/128 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Nervous system disorders
Ischaemic stroke
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Nervous system disorders
Reversible ischaemic neurological def.
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Nervous system disorders
Syncope
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Psychiatric disorders
Delirium
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Renal and urinary disorders
Renal impairment
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Renal and urinary disorders
Urinary retention
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.70%
1/143 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
1.4%
2/138 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
3/128 • Number of events 3 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
2.1%
3/143 • Number of events 3 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
1.4%
2/138 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
1.4%
2/143 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
1.4%
2/143 • Number of events 3 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
1.4%
2/138 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Vascular disorders
Deep vein thrombosis
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
1.4%
2/143 • Number of events 2 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Vascular disorders
Hypertension
|
0.78%
1/128 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/138 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/128 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.00%
0/143 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
Other adverse events
| Measure |
Placebo
n=128 participants at risk
Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII17.5IU/Kg
n=143 participants at risk
Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
FXIII35IU/Kg
n=138 participants at risk
Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.5%
25/128 • Number of events 25 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
16.8%
24/143 • Number of events 25 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
13.8%
19/138 • Number of events 19 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.0%
9/128 • Number of events 9 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
4.2%
6/143 • Number of events 6 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
8.0%
11/138 • Number of events 11 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.8%
10/128 • Number of events 11 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
3.5%
5/143 • Number of events 5 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
5.1%
7/138 • Number of events 7 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Atrial fibrillation
|
39.1%
50/128 • Number of events 56 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
31.5%
45/143 • Number of events 48 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
31.9%
44/138 • Number of events 49 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Low cardiac output syndrome
|
7.0%
9/128 • Number of events 9 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
2.1%
3/143 • Number of events 3 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
7.2%
10/138 • Number of events 10 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Cardiac disorders
Ventricular extrasystoles
|
4.7%
6/128 • Number of events 6 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
2.8%
4/143 • Number of events 4 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
5.1%
7/138 • Number of events 7 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Gastrointestinal disorders
Constipation
|
4.7%
6/128 • Number of events 6 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
4.2%
6/143 • Number of events 6 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
6.5%
9/138 • Number of events 9 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Gastrointestinal disorders
Nausea
|
26.6%
34/128 • Number of events 34 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
26.6%
38/143 • Number of events 38 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
33.3%
46/138 • Number of events 46 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
10/128 • Number of events 13 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
10.5%
15/143 • Number of events 15 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
15.2%
21/138 • Number of events 21 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
General disorders
Chills
|
9.4%
12/128 • Number of events 12 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
3.5%
5/143 • Number of events 5 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
5.8%
8/138 • Number of events 8 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
General disorders
Oedema peripheral
|
14.1%
18/128 • Number of events 19 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
16.1%
23/143 • Number of events 27 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
18.1%
25/138 • Number of events 28 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
General disorders
Pyrexia
|
13.3%
17/128 • Number of events 17 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
10.5%
15/143 • Number of events 15 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
10.1%
14/138 • Number of events 15 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
6.2%
8/128 • Number of events 8 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
4.9%
7/143 • Number of events 7 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
5.8%
8/138 • Number of events 9 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Injury, poisoning and procedural complications
Procedural pain
|
26.6%
34/128 • Number of events 35 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
31.5%
45/143 • Number of events 47 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
32.6%
45/138 • Number of events 47 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Injury, poisoning and procedural complications
Wound secretion
|
3.1%
4/128 • Number of events 4 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
2.8%
4/143 • Number of events 4 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
7.2%
10/138 • Number of events 10 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
3.1%
4/128 • Number of events 4 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
5.6%
8/143 • Number of events 8 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
2.2%
3/138 • Number of events 3 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Investigations
Urine output decreased
|
7.0%
9/128 • Number of events 9 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
6.3%
9/143 • Number of events 9 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
6.5%
9/138 • Number of events 9 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Metabolism and nutrition disorders
Fluid overload
|
8.6%
11/128 • Number of events 11 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
7.0%
10/143 • Number of events 10 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
10.9%
15/138 • Number of events 15 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
16/128 • Number of events 16 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
13.3%
19/143 • Number of events 19 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
15.2%
21/138 • Number of events 21 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
9.4%
12/128 • Number of events 12 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
8.4%
12/143 • Number of events 12 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
5.1%
7/138 • Number of events 7 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Nervous system disorders
Dizziness
|
3.1%
4/128 • Number of events 4 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
5.6%
8/143 • Number of events 9 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
6.5%
9/138 • Number of events 9 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Psychiatric disorders
Agitation
|
6.2%
8/128 • Number of events 9 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
3.5%
5/143 • Number of events 5 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
2.9%
4/138 • Number of events 4 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Psychiatric disorders
Delirium
|
7.8%
10/128 • Number of events 10 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
2.1%
3/143 • Number of events 3 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
0.72%
1/138 • Number of events 1 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Renal and urinary disorders
Renal impairment
|
7.0%
9/128 • Number of events 10 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
7.0%
10/143 • Number of events 11 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
2.9%
4/138 • Number of events 4 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
10.2%
13/128 • Number of events 13 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
10.5%
15/143 • Number of events 16 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
9.4%
13/138 • Number of events 13 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.5%
7/128 • Number of events 7 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
4.9%
7/143 • Number of events 7 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
6.5%
9/138 • Number of events 9 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
37.5%
48/128 • Number of events 50 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
29.4%
42/143 • Number of events 45 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
37.7%
52/138 • Number of events 54 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Vascular disorders
Hypertension
|
3.9%
5/128 • Number of events 5 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
3.5%
5/143 • Number of events 5 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
9.4%
13/138 • Number of events 13 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Vascular disorders
Hypotension
|
21.9%
28/128 • Number of events 29 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
11.9%
17/143 • Number of events 17 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
15.2%
21/138 • Number of events 22 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
|
Vascular disorders
Haemorrhage
|
3.1%
4/128 • Number of events 4 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
6.3%
9/143 • Number of events 9 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
3.6%
5/138 • Number of events 5 • Adverse events were reported from the time of rFXIII dosing until day 7 or discharge (whichever came first), while serious adverse events were reported from the time of rFXIII dosing until the follow-up visit at 5-7 weeks after trial drug administration.
Safety analysis set were all subjects who have been exposed to at least one dose of trial drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk maintains the right to be informed of any investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
- Publication restrictions are in place
Restriction type: OTHER