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| Name | Class |
|---|---|
| MedPass International | INDUSTRY |
Not provided
Not provided
M-Trap is an implantable medical device designed to capture disseminated tumor cells (DTCs). It is intended for use in advanced-stage ovarian cancer patients. The study objective is to assess the safety and the performance of the M-Trap device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M-Trap | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M-Trap | Device | Device(s) will be surgically implanted in the peritoneal cavity. Up to three (3) M-Trap devices will be surgically implanted via laparotomy in the right and left paracolic (pelvic) gutters and behind segment 6 of the liver within the peritoneal cavity of the patient at the time of surgical resection. Patients will receive standard platinum-based chemotherapy. If the cancer is diagnosed to have recurred, M-Trap devices with captured tumor cells will be removed via minimally invasive surgery (laparoscopy). |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events | The primary objective is to demonstrate that the safety of M-Trap, as measured by freedom from device- and procedure-related major adverse events through 6-months post-implantation, is non-inferior to historical controls (Patankar 2015). Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 6-months post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites. | 6 months |
| Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events | An additional analysis was performed to assess safety of M-Trap in comparison to historical controls at a comparable 30 day timepoint, as measured by freedom from device- and procedure-related major adverse events through 30 days post-implantation. Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 30-days post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites, adjusted based on the breakdown of the historical control population by number of extended procedures | 30 days |
| Performance: Number of Participants With Histological Evidence of Tumor Cell Capture | Histological evidence of tumor cell capture in at least one device in patients who underwent successful device removal | Time of device removal, an average of 13.3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Number of Participants With Device-related Long-term Adverse Event Reporting | Device-related long-term adverse events and serious adverse events reported through 18 months | 18 months |
| Safety: Number of Participants With Procedure-related Long-term Adverse Event Reporting |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Devices Implanted | Number of devices implanted at conclusion of debulking surgery. | Immediately post-procedure |
| Disease Focalization Score by Recurrence Status | Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device |
Inclusion Criteria:
Is a female ≥18 years old.
Presents with a diagnosis of Stage IIIC ovarian cancer.
Presents with high-grade serous carcinoma.
Has one of the following:
ECOG performance status of 0 or 1.
Is willing to comply with required follow-up study visits.
Is willing and able to provide written informed consent.
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Gil-Moreno, MD | Hospital Vall d'Hebron | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain | |||
| Hospital Clinic de Barcelona |
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Prospective, multi-center, non-blinded, single-arm study
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | M-Trap | M-Trap: Device(s) will be surgically implanted in the peritoneal cavity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | M-Trap | M-Trap: Device(s) will be surgically implanted in the peritoneal cavity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events | The primary objective is to demonstrate that the safety of M-Trap, as measured by freedom from device- and procedure-related major adverse events through 6-months post-implantation, is non-inferior to historical controls (Patankar 2015). Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 6-months post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites. | All enrolled patients | Posted | Count of Participants | Participants | 6 months |
|
18 months
Any adverse event (AE) observed was fully investigated by the Investigator and classified in line with the definitions of the ISO 14155:2011. AEs were collected from patients and their medical records at each follow-up interval (discharge, 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, and 18 months).
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 | M-Trap | M-Trap: Device(s) will be surgically implanted in the peritoneal cavity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, RA/QA/CA | MTrap | 3013258537 | cmitchell@m-trap.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 | Sep 12, 2017 | Dec 12, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 10, 2019 | Dec 12, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
Prospective, multi-center, non-blinded, single-arm study
Not provided
Not provided
Not provided
Not provided
|
Procedure-related long-term adverse events and serious adverse events reported through 18 months |
| 18 months |
| Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device. Results are presented as described in secondary objective: patient count of score I; score I or II; score I, II or III; score I, II, III or IV; or No focalization. | Time of recurrence, an average of 14.5 months |
| Time of recurrence, an average of 14.5 months |
| Number of Participants With Reasons for Device Removal | Reason that device removal was planned, regardless of whether or not it was completed. | Time of device removal, an average of 13.3 months |
| Barcelona |
| 08036 |
| Spain |
| Castellon University General Hospital | Castelló | 12004 | Spain |
| MD Anderson Cancer Center | Madrid | 28033 | Spain |
| Hospital La Paz Madrid | Madrid | 28046 | Spain |
| Complexo Hospitalario Universitario de Santiago | Santiago de Compostela | 15706 | Spain |
| Valencia-Hospital General | Valencia | 46014 | Spain |
| Hospital Universitrio y Politècnico La Fe | Valencia | 46026 | Spain |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Ovarian Cancer Stage | Staging is the process of finding out how much cancer is in a person's body and where it's located. Stage IIIC: Cancer has spread to the peritoneum and the cancer in the peritoneum is larger than 2 centimeters and/or cancer has spread to lymph nodes in the abdomen. Stage IVA: Cancer cells are found in extra fluid that has built up around the lungs. Stage IVB: Cancer has spread to organs and tissues outside the abdomen, including lymph nodes in the groin. | Count of Participants | Participants |
|
| ECOG Performance Status | Eastern Cooperative Oncology Group GRADE 0 Fully active, able to carry on all pre-disease performance without restriction GRADE 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature GRADE 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours GRADE 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours GRADE 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair GRADE 5 Dead | Count of Participants | Participants |
|
| Pregnancy | Count of Participants | Participants |
|
| BMI | 1 missing | Mean | Standard Deviation | kg/m^2 |
|
| Type of debulking procedure | Primary debulking has no chemotherapy treatment prior to the debulking surgery. Interval debulking has 3 to 4 rounds of chemotherapy treatment prior to the debulking surgery with the aim of reducing the tumor burden prior to surgery. | Count of Participants | Participants |
|
| Pre-debulking PCI | Peritoneal cancer index (PCI) - assesses extent of peritoneal cancer in peritoneal cavity. Peritoneal cavity is divided in 13 well-defined regions. In each region, the size of the largest tumor nodule is measured. If no tumor is visualized, score is "0". If the largest tumor nodule is smaller than 0.5 cm, score is "1". If tumor measures between 0.5 cm and 5 cm, score is "2". If lesion is larger than 5 cm, the score is "3". If layering or a confluence of multiple small tumor nodules, score is "3". PCI is calculated by adding the scores of all regions together with a max of 39 (13×3). | Analysis on complete population and sub-analysis by type of debulking surgery. | Mean | Standard Deviation | scores on a scale |
|
| Post-debulking PCI | Peritoneal cancer index (PCI) - assesses extent of peritoneal cancer in peritoneal cavity. Peritoneal cavity is divided in 13 well-defined regions. In each region, the size of the largest tumor nodule is measured. If no tumor is visualized, score is "0". If the largest tumor nodule is smaller than 0.5 cm, score is "1". If tumor measures between 0.5 cm and 5 cm, score is "2". If lesion is larger than 5 cm, the score is "3". If layering or a confluence of multiple small tumor nodules, score is "3". PCI is calculated by adding the scores of all regions together with a max of 39 (13×3). | Measure Analysis Population Description: Analysis on complete population and sub-analysis by type of debulking surgery. | Mean | Standard Deviation | scores on a scale |
|
| Pre-operative serum albumin | Data not recorded for two patients. | Mean | Standard Deviation | g/dl |
|
| Pre-operative hemoglobin | Mean | Standard Deviation | g/dl |
|
| Total number of extended procedures | Total number of extended procedures per the Patankar definition. Extended procedures of interest included lymphadenectomy, small bowel resection, colectomy, rectosigmoid resection, hepatic resection, bladder resection, diaphragm resection and cytoreduction. | Count of Participants | Participants |
|
M-Trap: Device(s) will be surgically implanted in the peritoneal cavity at time of surgical debulking. |
|
|
|
| Primary | Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events | An additional analysis was performed to assess safety of M-Trap in comparison to historical controls at a comparable 30 day timepoint, as measured by freedom from device- and procedure-related major adverse events through 30 days post-implantation. Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 30-days post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites, adjusted based on the breakdown of the historical control population by number of extended procedures | All enrolled patients | Posted | Count of Participants | Participants | 30 days |
|
|
|
|
| Primary | Performance: Number of Participants With Histological Evidence of Tumor Cell Capture | Histological evidence of tumor cell capture in at least one device in patients who underwent successful device removal | Assessment was completed in all patients who underwent successful device removal. | Posted | Count of Participants | Participants | Time of device removal, an average of 13.3 months |
|
|
|
| Secondary | Safety: Number of Participants With Device-related Long-term Adverse Event Reporting | Device-related long-term adverse events and serious adverse events reported through 18 months | All enrolled patients | Posted | Count of Participants | Participants | 18 months |
|
|
|
| Secondary | Safety: Number of Participants With Procedure-related Long-term Adverse Event Reporting | Procedure-related long-term adverse events and serious adverse events reported through 18 months | All enrolled patients | Posted | Count of Participants | Participants | 18 months |
|
|
|
| Secondary | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device. Results are presented as described in secondary objective: patient count of score I; score I or II; score I, II or III; score I, II, III or IV; or No focalization. | All patients with disease focalization scores reported | Posted | Count of Participants | Participants | Time of recurrence, an average of 14.5 months |
|
|
|
| Other Pre-specified | Number of Devices Implanted | Number of devices implanted at conclusion of debulking surgery. | All patients | Posted | Count of Participants | Participants | Immediately post-procedure |
|
|
|
| Other Pre-specified | Disease Focalization Score by Recurrence Status | Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device | All patients with disease focalization scores reported | Posted | Count of Participants | Participants | Time of recurrence, an average of 14.5 months |
|
|
|
| Other Pre-specified | Number of Participants With Reasons for Device Removal | Reason that device removal was planned, regardless of whether or not it was completed. | All enrolled patients | Posted | Count of Participants | Participants | Time of device removal, an average of 13.3 months |
|
|
|
| Post-Hoc | Tumor Cell Infiltration | Estimate of tumor cell infiltration into the device based on histopathological analysis of devices from recurrent patients who underwent successful device removal. Percentage of device was determined by analysis of one slide from one tissue block (0.3 cm thick), by considering the amount of tumor cells in comparison to the total number of cells present in the slide when analyzed using image analysis with a digital slide scanner [Membrane Quant Module, Panoramic 250 FLASH II 2.0 (3D HISTEC)]. | Recurrent patients who underwent successful device removal | Posted | Mean | Standard Deviation | percentage of device | Time of recurrence, an average of 14.5 months |
|
|
|
| 2 |
| 23 |
| 11 |
| 23 |
| 23 |
| 23 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Procedural hemorrhage; disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Enterocutaneous fistula | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intestinal anastomosis complication | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pancreatic fistula | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Death | General disorders | MedDRA | Systematic Assessment |
|
| Escherichia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Post-operative fever | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Post-operative respiratory failure | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Staphylococcal bacteraemia; Intervertebral discitis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Bronchoplegia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Distributive shock | Vascular disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Localised intraabdominal fluid collection | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Procedural hemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Neurotoxicity | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Postoperative renal failure | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Diarrhoea infectious | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pyelonephritis fungal | Infections and infestations | MedDRA | Systematic Assessment |
|
| Subdiaphragmatic abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Febrile neutropenia | General disorders | MedDRA | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
|
| Edema | General disorders | MedDRA | Systematic Assessment |
|
| Edema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebrospinal fluid leakage | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Hemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Breast discharge | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Ovarian vein thrombosis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Vaginal fistula | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA | Systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
|
| Anemia; transfusion | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Vomiting; diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Lymphocele | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
Not provided
Not provided
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| I or II |
|
| I, II or III |
|
| I, II, III or IV |
|
| No focalization |
|
| II (~75% focalized |
|
| III (~50% focalized) |
|
| IV (~25% focalized) |
|
| V (no focalization) |
|
| Major adverse event not related with the device |
|
| Death prior to removal |
|