Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001163-20 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
| ICON Clinical Research | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The main purpose of this study was to demonstrate the efficacy and safety of intraoperative use of fibrinogen concentrate BT524, as a complementary therapy for the management of uncontrolled severe hemorrhage in acquired hypofibrinogenemia. This non-inferiority study focused on the primary objective of demonstrating that BT524 is non-inferior that means not worse than the comparator fresh frozen plasma/cryoprecipitate in reducing intraoperative blood loss when administered intravenously in subjects with acquired hypofibrinogenemia undergoing elective major spinal or abdominal surgery.
Fibrinogen is the first coagulation factor to become critically reduced during intraoperative bleeding. Therefore, rapid supplementation of fibrinogen to restore physiological plasma levels is an important component in achieving and maintaining hemostasis in bleeding patients. In this study, subjects with major blood loss during elective spinal surgery or abdominal surgery were randomized to receive either intravenous transfusion of the fibrinogen concentrate BT524, or fibrinogen-containing fresh frozen plasma/cryoprecipitate as first hemostatic intervention to rapidly replenish fibrinogen and control bleeding.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BT524 | Experimental | Investigational Human Fibrinogen Concentrate |
|
| Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo) | Active Comparator | Standard of Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BT524 | Biological | BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-operative Blood Loss | Intra-operative blood loss as measured by amount of blood from blood suction unit and amount of blood from surgical cloths and compresses. | From decision to treat the subject with IMP until end of surgery, an average of 5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion (%) of Subjects With Successful Correction of Fibrinogen Level (FIBTEM A10) 15 Minutes After Start of First IMP Administration | Successful correction of the fibrinogen level is defined as restoring fibrinogen FIBTEM A10 baseline (prior surgery) levels measured by ROTEM (thromboelastometry) 15 minutes after start of first IMP administration | Prior first dose, 15 minutes after start of first IMP administration |
Not provided
Inclusion Criteria:
At screening:
Intra-operative:
5.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Niels Rahe-Meyer, Prof. | Franziskus Hospital, Bielefeld | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 02 | Jette | Belgium | ||||
| Site 01 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42247815 | Derived | Roy A, Stanford S, Cecil T, Preston N, Rowley J, Porter P, Schimo S, Abraha S, Staus A, Balaban U, Wessels-Kranz J, Schuttrumpf J, Aigner S, Bohm H, Rahe-Meyer N. Efficacy and safety of fibrinogen concentrate (BT524) in severe hemorrhage: Phase 3 subcohort analysis of the AdFIrst trial in patients undergoing cytoreductive surgery for pseudomyxoma peritonei. J Clin Anesth. 2026 Jun 5;113:112242. doi: 10.1016/j.jclinane.2026.112242. Online ahead of print. | |
| 40741224 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
There were 117 screen failures due to the following reasons: Eligibility criteria not met (before surgery), n=11; Intra-operative eligibility criterion not met, n=69; Physician decision, n=21; Adverse event, n=2; Withdrawal by subject, n=10; Technical reason, n=3; Other, n=1. Subjects eligible for randomization: n=222.
339 subjects were screened, of these 222 subjects were eligible for the study and randomized. Baseline characteristics are available for the 222 randomized subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BT524 | Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition. |
| FG001 | FFP/Cryo | Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards. FFP, 15 mL per kg body weight (BW); Cryo, fixed dose of 10 units. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BT524 | Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition. |
| BG001 | FFP/Cryo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intra-operative Blood Loss | Intra-operative blood loss as measured by amount of blood from blood suction unit and amount of blood from surgical cloths and compresses. | Per-protocol set (PPS): All randomized subjects receiving IMP post randomization and with data collected post randomization. Subjects who were compliant with the trial protocol without any major protocol deviations thought to have the potential to impact the results of the efficacy analysis, e.g., no treatment or incomplete treatment with study intervention (BT524 or FFP/Cryo) during surgery, no postdose efficacy assessment for the primary endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | mL | From decision to treat the subject with IMP until end of surgery, an average of 5 hours |
|
From day of surgery to closing visit (up to 181 days)
Treatment emergent Adverse Events (TEAEs) defined as any Adverse Events (AEs) with start during or after administration of Investigational Medicinal Product (IMP) until the subject's last trial visit. Non-TEAEs defined as any AEs after signing the Informed Consent Form (ICF) and prior administration of IMP. Analyses were focused on TEAEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BT524 | Investigational Human Fibrinogen Concentrate BT524: BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christina Erb | Biotest AG | 00496103801 | 0 | christina.erb@biotest.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: 995_Protocol_V4.0 | Dec 4, 2019 | Nov 26, 2024 | Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: 995_Protocol_V4.3_UK | Sep 6, 2021 | Nov 27, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 19, 2023 | Nov 26, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 12, 2019 | Nov 26, 2024 | ICF_003.pdf |
Not provided
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D000347 | Afibrinogenemia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C026912 | cryoprecipitate coagulum |
Not provided
Not provided
Not provided
Patients were randomly assigned to treatment with BT524 or FFP/Cryo.
Not provided
Not provided
Study 995 was partially blinded; surgeon, surgical staff and subjects were blinded to treatment allocation throughout the entire surgery. The subject was blinded throughout the study. The Investigational Medicinal Product (IMP), BT524 or FFP/Cryo, was administered by an unblinded anaesthesiologist.
|
| FFP/Cryo | Biological | FFP/Cryo was administered intravenously; dosage according to local standards. FFP, 15 mL per kg body weight (BW); Cryoprecipitate, fixed dose of 10 units. |
|
|
| Time to First Successful Correction of Fibrinogen Level | Correction of the fibrinogen level, measured via thromboelastometry (ROTEM/FIBTEM A10), within 15 minutes after IMP start, between 15 and 90 minutes after IMP start, after 90 minutes after IMP start, or unsuccessful correction. The 4 categories were compared between the two treatment arms using a Chi-square test. | prior 1st dose, pre-dose, 15 minutes and 90 minutes after start of first IMP administration, end of surgery |
| Transfusion Requirements: Cell Salvage | Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture. | After start of first IMP administration until end of surgery, an average of 5 hours |
| Transfusion Requirements: Allogeneic Platelets | Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture. | After start of first IMP administration until end of surgery, an average of 5 hours |
| Transfusion Requirements: Allogeneic Red Blood Cells | Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture. | After start of first IMP administration until end of surgery, an average of 5 hours |
| Transfusion Requirements: Fresh Frozen Plasma | Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture. | After start of first IMP administration until end of surgery, an average of 5 hours |
| Transfusion Requirements, Cryoprecipitate | Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture. | After start of first IMP administration until end of surgery, an average of 5 hours |
| Amount of Red Blood Cells (RBCs) | Amount (volume) of RBCs (allogenic and autologous RBCs) infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture. | After start of first IMP administration until end of surgery, an average of 5 hours |
| Post-operative Blood Loss | Post-operative drainage volume in the first 24 hours after end of surgery | From end of surgery (time of last suture) up to 24 hours after the end of surgery |
| Subjects With Rebleeds | Proportion (%) of subjects with rebleeds after the end of surgery until day 8 | End of surgery up to 8 days after surgery |
| Hospital Length of Stay After Surgery | Length of stay after surgery (days) = 'date of hospital discharge' minus 'date of surgery'. Where date of discharge is the date of discharge following the IMP treated surgery. | From day of surgery until day of hospital discharge, an average of 16 days (up to 56 days) |
| In-hospital Mortality | Number and percentages of subjects who died during hospital stay | From day of surgery until day of hospital discharge, an average of 16 days (up to 56 days) |
| Number of Subjects With Thrombosis or Thromboembolic Events (TEEs) | Total number of subjects with thrombosis or TEEs documented as treatment-emergent adverse events of special interest | From day of surgery until closing visit (up to 181 days) |
| Change in Viral Status | Number of subjects with change in status of viral infections | Screening visit (up to 42 days prior to surgery) and closing visit (up to 181 days after surgery) |
| Leuven |
| Belgium |
| Site 54 | Brno | Czechia |
| Site 51 | Prague | Czechia |
| Site 53 | Prague | Czechia |
| Site 52 | Ústà nad Labem | Czechia |
| Site 15 | Bielefeld | Germany |
| Site 11 | Bonn | Germany |
| Site 12 | Hanover | Germany |
| Site 14 | München | Germany |
| Site 13 | Münster | Germany |
| Site 21 | Warsaw | Poland |
| Site 31 | Barcelona | Spain |
| Site 32 | Barcelona | Spain |
| Site 33 | Barcelona | Spain |
| Site34 | Barcelona | Spain |
| Site 41 | Liestal | Switzerland |
| Site 43 | Zurich | Switzerland |
| Site 71 | Basingstoke | United Kingdom |
| Derived |
| Rahe-Meyer N, Roy A, Trouillier HH, Schimo S, Wessels-Kranz J, Abraha S, Staus A, Balaban U, Hader T, Schuttrumpf J, Aigner S, Bohm H. Efficacy and safety of human fibrinogen concentrate (BT524) in patients with major haemorrhage undergoing major orthopaedic or abdominal surgery (AdFIrst): a randomised, active-controlled, multicentre, partially blinded, phase 3 non-inferiority trial. EClinicalMedicine. 2025 Jun 7;85:103264. doi: 10.1016/j.eclinm.2025.103264. eCollection 2025 Jul. |
| Protocol Violation |
|
| Lack of Trial Compliance |
|
| Physical disability to come to the site for the closing visit |
|
Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards. FFP, 15 mL per kg BW; Cryo, fixed dose of 10 units. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Expected Blood Loss | Number | participants |
|
| OG001 | Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo) | Standard of Care Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo): FFP/Cryo was administered intravenously; dosage according to local standards. |
|
|
|
| Secondary | Proportion (%) of Subjects With Successful Correction of Fibrinogen Level (FIBTEM A10) 15 Minutes After Start of First IMP Administration | Successful correction of the fibrinogen level is defined as restoring fibrinogen FIBTEM A10 baseline (prior surgery) levels measured by ROTEM (thromboelastometry) 15 minutes after start of first IMP administration | Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized. | Posted | Count of Participants | Participants | Prior first dose, 15 minutes after start of first IMP administration |
|
|
|
|
| Secondary | Time to First Successful Correction of Fibrinogen Level | Correction of the fibrinogen level, measured via thromboelastometry (ROTEM/FIBTEM A10), within 15 minutes after IMP start, between 15 and 90 minutes after IMP start, after 90 minutes after IMP start, or unsuccessful correction. The 4 categories were compared between the two treatment arms using a Chi-square test. | Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized. | Posted | Count of Participants | Participants | prior 1st dose, pre-dose, 15 minutes and 90 minutes after start of first IMP administration, end of surgery |
|
|
|
|
| Secondary | Transfusion Requirements: Cell Salvage | Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture. | Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized. | Posted | Mean | Standard Deviation | mL | After start of first IMP administration until end of surgery, an average of 5 hours |
|
|
|
| Secondary | Transfusion Requirements: Allogeneic Platelets | Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture. | Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized. | Posted | Mean | Standard Deviation | mL | After start of first IMP administration until end of surgery, an average of 5 hours |
|
|
|
| Secondary | Transfusion Requirements: Allogeneic Red Blood Cells | Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture. | Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized. | Posted | Mean | Standard Deviation | mL | After start of first IMP administration until end of surgery, an average of 5 hours |
|
|
|
| Secondary | Transfusion Requirements: Fresh Frozen Plasma | Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture. | Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized. | Posted | Mean | Standard Deviation | mL | After start of first IMP administration until end of surgery, an average of 5 hours |
|
|
|
| Secondary | Transfusion Requirements, Cryoprecipitate | Total amount of transfusion products (allogeneic blood products) or autologous blood transfusion infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture. | Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized. | Posted | Mean | Standard Deviation | mL | After start of first IMP administration until end of surgery, an average of 5 hours |
|
|
|
| Secondary | Amount of Red Blood Cells (RBCs) | Amount (volume) of RBCs (allogenic and autologous RBCs) infused after start of first IMP administration until end of surgery. The end of surgery is defined as time of last suture. | Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized. | Posted | Least Squares Mean | 95% Confidence Interval | mL | After start of first IMP administration until end of surgery, an average of 5 hours |
|
|
|
|
| Secondary | Post-operative Blood Loss | Post-operative drainage volume in the first 24 hours after end of surgery | Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized. | Posted | Least Squares Mean | 95% Confidence Interval | mL | From end of surgery (time of last suture) up to 24 hours after the end of surgery |
|
|
|
|
| Secondary | Subjects With Rebleeds | Proportion (%) of subjects with rebleeds after the end of surgery until day 8 | Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized. | Posted | Count of Participants | Participants | End of surgery up to 8 days after surgery |
|
|
|
|
| Secondary | Hospital Length of Stay After Surgery | Length of stay after surgery (days) = 'date of hospital discharge' minus 'date of surgery'. Where date of discharge is the date of discharge following the IMP treated surgery. | Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized. | Posted | Count of Participants | Participants | From day of surgery until day of hospital discharge, an average of 16 days (up to 56 days) |
|
|
|
| Secondary | In-hospital Mortality | Number and percentages of subjects who died during hospital stay | Modified Full Analysis Set (mFAS): All randomized subjects who received at least one dose of IMP prior to the 'end of surgery' and have at least one postdose efficacy assessment. This included all subjects whose IMP infusion started prior to the end of surgery, irrespective of the amount of IMP infused. Subjects were analyzed as randomized. | Posted | Count of Participants | Participants | From day of surgery until day of hospital discharge, an average of 16 days (up to 56 days) |
|
|
|
| Secondary | Number of Subjects With Thrombosis or Thromboembolic Events (TEEs) | Total number of subjects with thrombosis or TEEs documented as treatment-emergent adverse events of special interest | Safety Analysis Set (SAF): All subjects who have received at least one dose of IMP. | Posted | Count of Participants | Participants | From day of surgery until closing visit (up to 181 days) |
|
|
|
| Secondary | Change in Viral Status | Number of subjects with change in status of viral infections | Safety Analysis Set (SAF): All subjects who have received at least one dose of IMP. | Posted | Count of Participants | Participants | Screening visit (up to 42 days prior to surgery) and closing visit (up to 181 days after surgery) |
|
|
|
| 0 |
| 110 |
| 28 |
| 110 |
| 92 |
| 110 |
| EG001 | Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo) | Standard of Care FFP/Cryo: FFP/Cryo was administered intravenously; dosage according to local standards. | 1 | 112 | 41 | 112 | 93 | 112 |
| Hypovolaemic shock | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Neurogenic shock | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 26.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Chest pain | General disorders | MedDRA 26.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Pain | General disorders | MedDRA 26.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Surgical failure | General disorders | MedDRA 26.1 | Systematic Assessment | General disorders and administration site conditions |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Dural tear | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Bladder injuryI | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Stoma site haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Wound haematoma | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Cerebrospinal fluid leakage | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Paraparesis | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Paraplegia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Haemorrhagic diathesis | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Gastric perforation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Ileal perforation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Inguinal hernia strangulated | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Meningitis bacterial | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
Not provided
Not provided
| D006425 |
| Hemic and Lymphatic Diseases |
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D020147 | Coagulation Protein Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| >90 minutes after IMP start |
|
| Unsuccessful correction |
|
| 22-28 days |
|
| 15-21 days |
|
| 8-14 days |
|
| 1-7 days |
|