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The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in pediatric population.
This is an open-label, multicenter, single-arm study evaluating the safety and effectiveness of EVARREST in controlling mild or moderate bleeding in hepatic parenchyma or soft tissue for which standard methods of achieving hemostasis are ineffective or impractical.
Eligible subjects will be treated with EVARREST. Subjects will be followed post-operatively through discharge and at 30 days (+/-14 days) post-surgery.
At least thirty-five pediatric subjects with an appropriate mild or moderate bleeding target bleeding site (TBS) will be enrolled in this study. The age of the subjects enrolled in the study will be from 1 month to less than (<) 18 years. This will include a minimum of 4 subjects aged 1 month (greater than or equal to [>=] 28 days from birth) to <1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVARREST® Fibrin Sealant Patch | Experimental | EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVARREST® Fibrin Sealant Patch | Biological | EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Time to Hemostasis | Hemostasis was defined as no detectable bleeding at the TBS. Absolute time to hemostasis was defined as the absolute time elapsed from TBS identification to the last moment in time at which detectable bleeding at the TBS was observed. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression. | During surgical procedure on Day 0 (from TBS identification to the last moment in time at which detectable bleeding at TBS observed) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Hemostatic Success at 4 Minutes | Percentage of participants who achieved hemostatic success at 4 minutes was reported. A participant was considered hemostatic success at 4 minutes if the TBS was hemostatic at 4 minutes, and there was no re-bleeding that required treatment (other than observation only) at the TBS from 4 minutes following the first TBS identification through final fascial closure. Hemostasis was assessed at 4 minutes from TBS identification by carefully releasing manual compression and removing the surgical sponge (if used). TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Hospital | Birmingham | Alabama | 35222 | United States | ||
| icahn School of Medicine at Mt Sinai |
Efficacy and safety results related to the primary and secondary endpoints
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| ID | Title | Description |
|---|---|---|
| FG000 | EVARREST Fibrin Sealant Patch | Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EVARREST Fibrin Sealant Patch | Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery. |
| 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 | Absolute Time to Hemostasis | Hemostasis was defined as no detectable bleeding at the TBS. Absolute time to hemostasis was defined as the absolute time elapsed from TBS identification to the last moment in time at which detectable bleeding at the TBS was observed. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression. | Full analysis set (FAS) consisted of all enrolled and eligible participants for whom TBS was identified. | Posted | Median | 95% Confidence Interval | Minutes | During surgical procedure on Day 0 (from TBS identification to the last moment in time at which detectable bleeding at TBS observed) |
|
From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EVARREST Fibrin Sealant Patch | Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA19.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA19.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SR. FRANCHISE MEDICAL DIRECTOR | Ethicon, Inc. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 2, 2023 | Mar 20, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 27, 2024 | Mar 20, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
|
| 4 minutes after TBS identification (during surgical procedure on Day 0) |
| Percentage of Participants Who Achieved Hemostatic Success at 10 Minutes | Percentage of participants who achieved hemostatic success at 10 minutes was reported. A participant was considered hemostatic success at 10 minutes if the TBS was hemostatic at 10 minutes, and there was no re-bleeding that required treatment (other than observation only) at the TBS from 10 minutes following the first TBS identification through final fascial closure. Hemostasis was assessed at 10 minutes from TBS identification and at initiation of final fascial closure. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression. | 10 minutes after TBS identification (during surgical procedure on Day 0) |
| Percentage of Participants With No Re-bleeding at the TBS | Percentage of participants with no re-bleeding at the TBS was reported. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression. | During surgical procedure on Day 0 (from TBS identification to final fascial closure) |
| Percentage of Participants With Adverse Events That Were Potentially Related to Bleeding at the TBS | Percentage of participants with adverse events that were potentially related to bleeding at the TBS was reported. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression. An adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, without judgment about causality. | From the day of surgical procedure (Day 0) up to 44-days post-surgery |
| Percentage of Participants With Adverse Events That Were Potentially Related to Thrombotic Events | Percentage of participants with adverse events that were potentially related to thrombotic events at the TBS was reported. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression. An adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, without judgment about causality. | From the day of surgical procedure (Day 0) up to 44-days post-surgery |
| Percentage of Participants With Re-treatment at the TBS | Percentage of participants with re-treatment at the TBS was reported. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression. | From the day of surgical procedure (Day 0) up to 44-days post-surgery |
| Percentage of Participants With Adverse Events | Percentage of participants with adverse events (including serious and non-serious) were reported. An adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, without judgment about causality. Data is reported for participants with at least one AE. Participants having more than one AE are counted only once in this outcome measure. | From the day of surgical procedure (Day 0) up to 44-days post-surgery |
| Change From Baseline in Laboratory Parameter: Hemoglobin | Change from baseline in laboratory parameter (hemoglobin) was reported. | From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0) |
| Change From Baseline in Laboratory Parameter: Hematocrit | Change from baseline in laboratory parameter (hematocrit; expressed as liters of cells per liter of blood) was reported. | From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0) |
| Change From Baseline in Laboratory Parameter: Platelets | Change from baseline in laboratory parameter (platelets) was reported. | From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0) |
| Estimated Intraoperative Blood Loss | Estimated intraoperative blood loss was reported. | During surgical procedure on Day 0 |
| Number of Participants With Blood Products Transfusion | Number of participants with blood products transfusion was reported. | From the day of surgical procedure (Day 0) up to 44-days post-surgery |
| New York |
| New York |
| 10029 |
| United States |
| Birmingham Chrildren's Hospital | Birmingham | B4 6NH | United Kingdom |
| Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Southampton University Hospital | Southampton | SO16 6YD | United Kingdom |
| 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 |
|
|
|
| Secondary | Percentage of Participants Who Achieved Hemostatic Success at 4 Minutes | Percentage of participants who achieved hemostatic success at 4 minutes was reported. A participant was considered hemostatic success at 4 minutes if the TBS was hemostatic at 4 minutes, and there was no re-bleeding that required treatment (other than observation only) at the TBS from 4 minutes following the first TBS identification through final fascial closure. Hemostasis was assessed at 4 minutes from TBS identification by carefully releasing manual compression and removing the surgical sponge (if used). TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression. | FAS consisted of all enrolled and eligible participants for whom TBS was identified. | Posted | Number | 95% Confidence Interval | Percentage of participants | 4 minutes after TBS identification (during surgical procedure on Day 0) |
|
|
|
| Secondary | Percentage of Participants Who Achieved Hemostatic Success at 10 Minutes | Percentage of participants who achieved hemostatic success at 10 minutes was reported. A participant was considered hemostatic success at 10 minutes if the TBS was hemostatic at 10 minutes, and there was no re-bleeding that required treatment (other than observation only) at the TBS from 10 minutes following the first TBS identification through final fascial closure. Hemostasis was assessed at 10 minutes from TBS identification and at initiation of final fascial closure. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression. | FAS consisted of all enrolled and eligible participants for whom TBS was identified. | Posted | Number | 95% Confidence Interval | Percentage of participants | 10 minutes after TBS identification (during surgical procedure on Day 0) |
|
|
|
| Secondary | Percentage of Participants With No Re-bleeding at the TBS | Percentage of participants with no re-bleeding at the TBS was reported. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression. | FAS consisted of all enrolled and eligible participants for whom TBS was identified. | Posted | Number | Percentage of participants | During surgical procedure on Day 0 (from TBS identification to final fascial closure) |
|
|
|
| Secondary | Percentage of Participants With Adverse Events That Were Potentially Related to Bleeding at the TBS | Percentage of participants with adverse events that were potentially related to bleeding at the TBS was reported. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression. An adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, without judgment about causality. | Safety analysis set included all participants who received treatment. | Posted | Number | Percentage of participants | From the day of surgical procedure (Day 0) up to 44-days post-surgery |
|
|
|
| Secondary | Percentage of Participants With Adverse Events That Were Potentially Related to Thrombotic Events | Percentage of participants with adverse events that were potentially related to thrombotic events at the TBS was reported. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression. An adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, without judgment about causality. | Safety analysis set included all participants who received treatment. | Posted | Number | Percentage of participants | From the day of surgical procedure (Day 0) up to 44-days post-surgery |
|
|
|
| Secondary | Percentage of Participants With Re-treatment at the TBS | Percentage of participants with re-treatment at the TBS was reported. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression. | Safety analysis set included all participants who received treatment. | Posted | Number | Percentage of participants | From the day of surgical procedure (Day 0) up to 44-days post-surgery |
|
|
|
| Secondary | Percentage of Participants With Adverse Events | Percentage of participants with adverse events (including serious and non-serious) were reported. An adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, without judgment about causality. Data is reported for participants with at least one AE. Participants having more than one AE are counted only once in this outcome measure. | Safety analysis set included all participants who received treatment. | Posted | Number | Percentage of participants | From the day of surgical procedure (Day 0) up to 44-days post-surgery |
|
|
|
| Secondary | Change From Baseline in Laboratory Parameter: Hemoglobin | Change from baseline in laboratory parameter (hemoglobin) was reported. | Safety analysis set included all participants who received treatment. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Grams per liter (g/L) | From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0) |
|
|
|
| Secondary | Change From Baseline in Laboratory Parameter: Hematocrit | Change from baseline in laboratory parameter (hematocrit; expressed as liters of cells per liter of blood) was reported. | Safety analysis set included all participants who received treatment. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Liters per liter (L/L) | From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0) |
|
|
|
| Secondary | Change From Baseline in Laboratory Parameter: Platelets | Change from baseline in laboratory parameter (platelets) was reported. | Safety analysis set included all participants who received treatment. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | 10^9 cells per liter | From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0) |
|
|
|
| Secondary | Estimated Intraoperative Blood Loss | Estimated intraoperative blood loss was reported. | Safety analysis set included all participants who received treatment. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Milliliters (mL) | During surgical procedure on Day 0 |
|
|
|
| Secondary | Number of Participants With Blood Products Transfusion | Number of participants with blood products transfusion was reported. | Safety analysis set included all participants who received treatment. | Posted | Count of Participants | Participants | From the day of surgical procedure (Day 0) up to 44-days post-surgery |
|
|
|
| 0 |
| 35 |
| 9 |
| 35 |
| 21 |
| 35 |
| Pyrexia | General disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
|
| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
|
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Central venous catheterisation | Surgical and medical procedures | MedDRA19.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Feeling jittery | General disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Retrograde portal vein flow | Hepatobiliary disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
|
| Enterobacter infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
|
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Blood lactic acid increased | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Blood magnesium abnormal | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Blood potassium abnormal | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Body temperature decreased | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Coagulation time prolonged | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Culture urine positive | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Prothrombin time abnormal | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Respiratory rate decreased | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Staphylococcus test positive | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA19.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Device leakage | Product Issues | MedDRA19.0 | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Bladder dilatation | Renal and urinary disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Bradypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA19.0 | Non-systematic Assessment |
|
Any publication or other public presentation of results from this study requires prior review by ETHICON. Draft abstracts, manuscripts, and materials for presentation at scientific meetings must be sent to the sponsor at least 30 working days prior to abstract or other relevant submission deadlines.