Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003557-24 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the safety and effectiveness of EVARRESTâ„¢ Sealant Matrix (EVARRESTâ„¢ Fibrin Sealant Patch) (EVARRESTâ„¢) in controlling mild or moderate soft tissue & parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in paediatric patients.
This is an open label, prospective, randomised, multicentre, controlled, clinical study comparing EVARREST to SURGICEL (oxidized regenerated cellulose (ORC)) (Control) as an adjunct to haemostasis when conventional methods of controlling mild or moderate bleeding are ineffective or impractical during surgery in paediatric patients.
At least 40 qualified paediatric subjects with an appropriate mild or moderate bleeding Target Bleeding Site (TBS) will be randomised in a 1:1 allocation ratio to either EVARREST or SURGICEL (control). Absolute time to haemostasis will be assessed as well as haemostasis at 4 and 10 minutes from randomisation.
Enrolment will be staggered by age (as required by the European Medicines Agency (EMA) Paediatric Committee). The first 36 subjects enrolled will be aged ≥1 years to <18 years of age. Enrolment of a subsequent group will include 4 subjects from 1 month (≥ 28 days from birth) to <1 year of age will follow. Ongoing safety assessment will ensure adequate safety monitoring occur during the staged enrolment.
Subjects will be followed post-operatively through hospital discharge and at 30 days (+/-14 days) post-surgery.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVARRESTâ„¢ Sealant Matrix | Experimental | EVARRESTâ„¢ Sealant Matrix/Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). |
|
| SURGICEL® Absorbable Hemostat | Active Comparator | SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVARREST™ Sealant Matrix | Biological | EVARREST® Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Time to Haemostasis (TTH) | Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the target bleeding site (TBS) was observed. | Up to 1 day (Intraoperative) |
| Absolute Time to Haemostasis (TTH) by Age Group | Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the TBS was observed. | Up to 1 day (Intraoperative) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | Percentage of participants achieving haemostatic success at 4 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard Kocharian, MD, PhD | Ethicon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigation Site #32 | Brussels | 1020 | Belgium | |||
| Investigative Site #30 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | EVARREST Sealant Matrix | Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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 | Apr 29, 2020 | Oct 27, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| SURGICEL® | Device | SURGICEL® Absorbable Hemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. |
|
|
| 4 minutes post randomization (up to 1 day; intraoperative) |
| Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | Percentage of participants achieving haemostatic success at 10 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported. | 10 minutes post randomization (up to 1 day; intraoperative) |
| Percentage of Participants With No Re-bleeding at the Target Bleeding Site | Percentage of participants with no re-bleeding at the TBS were reported. | Up to 44 days post-surgery on Day 0 |
| Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS | Number of participants With AEs that were potentially related to bleeding at the TBS were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Up to 44 days post-surgery on Day 0 |
| Number of Participants With AEs That Were Potentially Related To Thrombotic Events | Number of participants with AEs that were potentially related to thrombotic events (sponsor assessment) were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Up to 44 days post-surgery on Day 0 |
| Number of Participants Who Required Re-treatment At The Target Bleeding Site | Number of participants who required re-treatment at the TBS were reported. | Up to 44 days post-surgery on Day 0 |
| Number of Participants With Adverse Events | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Up to 44 days post-surgery on Day 0 |
| Change From Baseline to Post-surgery in Haemoglobin | Change from baseline to post-surgery in haemoglobin were reported. | From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0) |
| Change From Baseline to Post-surgery in Haematocrit | Change from baseline to post-surgery in Haematocrit was reported. | From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0) |
| Change From Baseline to Post-surgery in Platelet Count | Change from baseline to post-surgery in platelet count was reported. | From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0) |
| Estimated Volume of Blood Loss | Estimated volume of intra-operative blood loss (including but not limited to the TBS) was reported. | Up to 1 day (intraoperative) |
| Number of Participants Who Received Blood Transfusions | Number of participants who received blood transfusions (red blood cells [RBCs], whole blood, fresh frozen plasma, platelets, and cryoprecipitates) were reported. | Up to 44 days post-surgery on Day 0 |
| Genk |
| Belgium |
| Clinical Investigation Site #31 | Ghent | Belgium |
| Clinical Investigation Site #21 | Birmingham | United Kingdom |
| Clinical Investigation Site #22 | Leeds | United Kingdom |
| Clinical Investigation Site #20 | Liverpool | United Kingdom |
| Clinical Investigation Site #26 | London | SE1 7EH | United Kingdom |
| Clinical Investigation Site #23 | London | United Kingdom |
| Clinical Investigation Site #25 | Nottingham | NG7 2UH | United Kingdom |
| Clinical Investigation Site #24 | Southampton | SO16 6YD | United Kingdom |
| FG001 | SURGICEL Absorbable Hemostat (Control) | Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EVARREST Sealant Matrix | Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). |
| BG001 | SURGICEL Absorbable Hemostat (Control) | Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 Haemostasis (TTH) | Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the target bleeding site (TBS) was observed. | The Full Analysis Set (FAS; equivalent to the Intent-to-Treat [ITT] set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis. | Posted | Median | Full Range | Minutes | Up to 1 day (Intraoperative) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | Percentage of participants achieving haemostatic success at 4 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported. | The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 4 minutes post randomization (up to 1 day; intraoperative) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | Percentage of participants achieving haemostatic success at 10 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported. | The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 10 minutes post randomization (up to 1 day; intraoperative) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With No Re-bleeding at the Target Bleeding Site | Percentage of participants with no re-bleeding at the TBS were reported. | The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis. | Posted | Number | Percentage of Participants | Up to 44 days post-surgery on Day 0 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS | Number of participants With AEs that were potentially related to bleeding at the TBS were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | The safety analysis set consists of all participants who received treatment. | Posted | Count of Participants | Participants | Up to 44 days post-surgery on Day 0 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With AEs That Were Potentially Related To Thrombotic Events | Number of participants with AEs that were potentially related to thrombotic events (sponsor assessment) were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | The safety analysis set consists of all participants who received treatment. | Posted | Count of Participants | Participants | Up to 44 days post-surgery on Day 0 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Required Re-treatment At The Target Bleeding Site | Number of participants who required re-treatment at the TBS were reported. | The safety analysis set consists of all participants who received treatment. | Posted | Count of Participants | Participants | Up to 44 days post-surgery on Day 0 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | The safety analysis set consists of all participants who received treatment. | Posted | Count of Participants | Participants | Up to 44 days post-surgery on Day 0 |
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Post-surgery in Haemoglobin | Change from baseline to post-surgery in haemoglobin were reported. | The safety analysis set consists of all participants who received treatment. Here, 'N' (number of participants analyzed) signifies number of participants who were analyzed for this outcome measure. | Posted | Median | Full Range | grams/liter (g/L) | From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0) |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Post-surgery in Haematocrit | Change from baseline to post-surgery in Haematocrit was reported. | The safety analysis set consists of all participants who received treatment. Here, 'N' (number of participants analyzed) signifies number of participants who were analyzed for this outcome measure. | Posted | Median | Full Range | Liter of cells per liter of blood (L/L) | From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0) |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Post-surgery in Platelet Count | Change from baseline to post-surgery in platelet count was reported. | The safety analysis set consists of all participants who received treatment. Here, 'N' (number of participants analyzed) signifies number of participants who were analyzed for this outcome measure. | Posted | Median | Full Range | 10^9 cells per liter | From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0) |
| ||||||||||||||||||||||||||||||
| Secondary | Estimated Volume of Blood Loss | Estimated volume of intra-operative blood loss (including but not limited to the TBS) was reported. | The FAS consisted of all randomized participants. Participants who did not completed the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis. | Posted | Median | Full Range | Milliliter (mL) | Up to 1 day (intraoperative) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Received Blood Transfusions | Number of participants who received blood transfusions (red blood cells [RBCs], whole blood, fresh frozen plasma, platelets, and cryoprecipitates) were reported. | The FAS consisted of all randomized participants. Participants who did not completed the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis. | Posted | Count of Participants | Participants | Up to 44 days post-surgery on Day 0 |
| |||||||||||||||||||||||||||||||
| Primary | Absolute Time to Haemostasis (TTH) by Age Group | Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the TBS was observed. | The Full Analysis Set (FAS; equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis. Here 'n' (number analyzed) signifies number of participants analyzed for specified categories. | Posted | Median | Full Range | Minutes | Up to 1 day (Intraoperative) |
|
Up to 44 days post-surgery on Day 0
The safety analysis set consists of all participants who received treatment.
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 | EVARREST Sealant Matrix | Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). | 0 | 20 | 4 | 20 | 18 | 20 |
| EG001 | SURGICEL Absorbable Hemostat (Control) | Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. | 0 | 20 | 5 | 20 | 17 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Neuroblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Localised intraabdominal fluid collection | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bloody Discharge | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Puncture site discharge | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Procedural hypotention | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Blood alkaline phosphate decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| International normalized ratio increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Horner's syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vulval oedema | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bradypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Device occlusion | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Anal injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | 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 60 days prior to submission for publication, public dissemination, or review by a publication committee.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Franchise Medical Director | Ethicon, Inc. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 15, 2020 | Oct 27, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|