Trial Outcomes & Findings for Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer (NCT NCT03085238)
NCT ID: NCT03085238
Last Updated: 2020-01-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
6 months
Results posted on
2020-01-27
Participant Flow
Prospective, multi-center, non-blinded, single-arm study
Participant milestones
| Measure |
M-Trap
M-Trap: Device(s) will be surgically implanted in the peritoneal cavity.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
1 Month
|
23
|
|
Overall Study
3 Months
|
22
|
|
Overall Study
6 Months
|
19
|
|
Overall Study
9 Months
|
16
|
|
Overall Study
12 Months
|
14
|
|
Overall Study
15 Months
|
11
|
|
Overall Study
18 Months
|
7
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
M-Trap
M-Trap: Device(s) will be surgically implanted in the peritoneal cavity.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
M-Trap
n=23 Participants
M-Trap: Device(s) will be surgically implanted in the peritoneal cavity.
|
|---|---|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 9.5 • n=23 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=23 Participants
|
|
Region of Enrollment
Spain
|
23 Participants
n=23 Participants
|
|
Ovarian Cancer Stage
IIIC
|
18 Participants
n=23 Participants
|
|
Ovarian Cancer Stage
IVA
|
1 Participants
n=23 Participants
|
|
Ovarian Cancer Stage
IVB
|
4 Participants
n=23 Participants
|
|
ECOG Performance Status
Grade 0
|
16 Participants
n=23 Participants
|
|
ECOG Performance Status
Grade 1
|
7 Participants
n=23 Participants
|
|
Pregnancy
Negative pregnancy test
|
2 Participants
n=23 Participants
|
|
Pregnancy
Prior hysterectomy
|
3 Participants
n=23 Participants
|
|
Pregnancy
Post-menopause
|
18 Participants
n=23 Participants
|
|
BMI
|
25.8 kg/m^2
STANDARD_DEVIATION 3.7 • n=22 Participants • 1 missing
|
|
Type of debulking procedure
Primary
|
8 Participants
n=23 Participants
|
|
Type of debulking procedure
Interval with 3 rounds of chemotherapy
|
11 Participants
n=23 Participants
|
|
Type of debulking procedure
Interval with 4 rounds of chemotherapy
|
4 Participants
n=23 Participants
|
|
Pre-debulking PCI
All patients
|
17.8 scores on a scale
STANDARD_DEVIATION 8.3 • n=23 Participants • Analysis on complete population and sub-analysis by type of debulking surgery.
|
|
Pre-debulking PCI
Primary debulking
|
25.5 scores on a scale
STANDARD_DEVIATION 3.4 • n=8 Participants • Analysis on complete population and sub-analysis by type of debulking surgery.
|
|
Pre-debulking PCI
Interval debulking
|
13.7 scores on a scale
STANDARD_DEVIATION 7.1 • n=15 Participants • Analysis on complete population and sub-analysis by type of debulking surgery.
|
|
Post-debulking PCI
All patients
|
1.3 scores on a scale
STANDARD_DEVIATION 1.5 • n=23 Participants • Measure Analysis Population Description: Analysis on complete population and sub-analysis by type of debulking surgery.
|
|
Post-debulking PCI
Primary debulking
|
2.7 scores on a scale
STANDARD_DEVIATION 1.1 • n=8 Participants • Measure Analysis Population Description: Analysis on complete population and sub-analysis by type of debulking surgery.
|
|
Post-debulking PCI
Interval debulking
|
0.6 scores on a scale
STANDARD_DEVIATION 1.1 • n=15 Participants • Measure Analysis Population Description: Analysis on complete population and sub-analysis by type of debulking surgery.
|
|
Pre-operative serum albumin
|
6.5 g/dl
STANDARD_DEVIATION 8.9 • n=21 Participants • Data not recorded for two patients.
|
|
Pre-operative hemoglobin
|
11.3 g/dl
STANDARD_DEVIATION 1.4 • n=23 Participants
|
|
Total number of extended procedures
1 extended procedure
|
1 Participants
n=23 Participants
|
|
Total number of extended procedures
2 extended procedures
|
8 Participants
n=23 Participants
|
|
Total number of extended procedures
3 or more extended procedures
|
14 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All enrolled patients
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.
Outcome measures
| Measure |
M-Trap
n=23 Participants
M-Trap: Device(s) will be surgically implanted in the peritoneal cavity at time of surgical debulking.
|
Platinum Sensitive, Recurrent Patients
Tumor cell capture in at least one device in patients determined to be recurrent and platinum-sensitive
|
Non-recurrent
Tumor cell capture in at least one device in patients who did not demonstrate recurrence
|
All Recurrent Patients
Tumor cell capture in at least one device in patients determined to be recurrent
|
All Patients
Tumor cell capture in at least one device in all patients
|
|---|---|---|---|---|---|
|
Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events
|
18 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 daysPopulation: All enrolled patients
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
Outcome measures
| Measure |
M-Trap
n=23 Participants
M-Trap: Device(s) will be surgically implanted in the peritoneal cavity at time of surgical debulking.
|
Platinum Sensitive, Recurrent Patients
Tumor cell capture in at least one device in patients determined to be recurrent and platinum-sensitive
|
Non-recurrent
Tumor cell capture in at least one device in patients who did not demonstrate recurrence
|
All Recurrent Patients
Tumor cell capture in at least one device in patients determined to be recurrent
|
All Patients
Tumor cell capture in at least one device in all patients
|
|---|---|---|---|---|---|
|
Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events
|
20 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Time of device removal, an average of 13.3 monthsPopulation: Assessment was completed in all patients who underwent successful device removal.
Histological evidence of tumor cell capture in at least one device in patients who underwent successful device removal
Outcome measures
| Measure |
M-Trap
n=4 Participants
M-Trap: Device(s) will be surgically implanted in the peritoneal cavity at time of surgical debulking.
|
Platinum Sensitive, Recurrent Patients
n=9 Participants
Tumor cell capture in at least one device in patients determined to be recurrent and platinum-sensitive
|
Non-recurrent
n=8 Participants
Tumor cell capture in at least one device in patients who did not demonstrate recurrence
|
All Recurrent Patients
n=13 Participants
Tumor cell capture in at least one device in patients determined to be recurrent
|
All Patients
n=21 Participants
Tumor cell capture in at least one device in all patients
|
|---|---|---|---|---|---|
|
Performance: Number of Participants With Histological Evidence of Tumor Cell Capture
|
2 Participants
|
6 Participants
|
2 Participants
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All enrolled patients
Device-related long-term adverse events and serious adverse events reported through 18 months
Outcome measures
| Measure |
M-Trap
n=23 Participants
M-Trap: Device(s) will be surgically implanted in the peritoneal cavity at time of surgical debulking.
|
Platinum Sensitive, Recurrent Patients
Tumor cell capture in at least one device in patients determined to be recurrent and platinum-sensitive
|
Non-recurrent
Tumor cell capture in at least one device in patients who did not demonstrate recurrence
|
All Recurrent Patients
Tumor cell capture in at least one device in patients determined to be recurrent
|
All Patients
Tumor cell capture in at least one device in all patients
|
|---|---|---|---|---|---|
|
Safety: Number of Participants With Device-related Long-term Adverse Event Reporting
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All enrolled patients
Procedure-related long-term adverse events and serious adverse events reported through 18 months
Outcome measures
| Measure |
M-Trap
n=23 Participants
M-Trap: Device(s) will be surgically implanted in the peritoneal cavity at time of surgical debulking.
|
Platinum Sensitive, Recurrent Patients
Tumor cell capture in at least one device in patients determined to be recurrent and platinum-sensitive
|
Non-recurrent
Tumor cell capture in at least one device in patients who did not demonstrate recurrence
|
All Recurrent Patients
Tumor cell capture in at least one device in patients determined to be recurrent
|
All Patients
Tumor cell capture in at least one device in all patients
|
|---|---|---|---|---|---|
|
Safety: Number of Participants With Procedure-related Long-term Adverse Event Reporting
|
21 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Time of recurrence, an average of 14.5 monthsPopulation: All patients with disease focalization scores reported
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.
Outcome measures
| Measure |
M-Trap
n=4 Participants
M-Trap: Device(s) will be surgically implanted in the peritoneal cavity at time of surgical debulking.
|
Platinum Sensitive, Recurrent Patients
n=10 Participants
Tumor cell capture in at least one device in patients determined to be recurrent and platinum-sensitive
|
Non-recurrent
n=7 Participants
Tumor cell capture in at least one device in patients who did not demonstrate recurrence
|
All Recurrent Patients
n=14 Participants
Tumor cell capture in at least one device in patients determined to be recurrent
|
All Patients
n=21 Participants
Tumor cell capture in at least one device in all patients
|
|---|---|---|---|---|---|
|
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
I
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
I or II
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
I, II or III
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
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
I, II, III or IV
|
2 Participants
|
7 Participants
|
0 Participants
|
9 Participants
|
9 Participants
|
|
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
No focalization
|
2 Participants
|
2 Participants
|
7 Participants
|
4 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately post-procedurePopulation: All patients
Number of devices implanted at conclusion of debulking surgery.
Outcome measures
| Measure |
M-Trap
n=23 Participants
M-Trap: Device(s) will be surgically implanted in the peritoneal cavity at time of surgical debulking.
|
Platinum Sensitive, Recurrent Patients
Tumor cell capture in at least one device in patients determined to be recurrent and platinum-sensitive
|
Non-recurrent
Tumor cell capture in at least one device in patients who did not demonstrate recurrence
|
All Recurrent Patients
Tumor cell capture in at least one device in patients determined to be recurrent
|
All Patients
Tumor cell capture in at least one device in all patients
|
|---|---|---|---|---|---|
|
Number of Devices Implanted
2 devices
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Devices Implanted
3 devices
|
22 Participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time of recurrence, an average of 14.5 monthsPopulation: All patients with disease focalization scores reported
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
Outcome measures
| Measure |
M-Trap
n=4 Participants
M-Trap: Device(s) will be surgically implanted in the peritoneal cavity at time of surgical debulking.
|
Platinum Sensitive, Recurrent Patients
n=10 Participants
Tumor cell capture in at least one device in patients determined to be recurrent and platinum-sensitive
|
Non-recurrent
n=7 Participants
Tumor cell capture in at least one device in patients who did not demonstrate recurrence
|
All Recurrent Patients
n=14 Participants
Tumor cell capture in at least one device in patients determined to be recurrent
|
All Patients
n=21 Participants
Tumor cell capture in at least one device in all patients
|
|---|---|---|---|---|---|
|
Disease Focalization Score by Recurrence Status
I (100% focalized)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Focalization Score by Recurrence Status
II (~75% focalized
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Focalization Score by Recurrence Status
III (~50% focalized)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Disease Focalization Score by Recurrence Status
IV (~25% focalized)
|
2 Participants
|
6 Participants
|
0 Participants
|
8 Participants
|
8 Participants
|
|
Disease Focalization Score by Recurrence Status
V (no focalization)
|
2 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
12 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time of device removal, an average of 13.3 monthsPopulation: All enrolled patients
Reason that device removal was planned, regardless of whether or not it was completed.
Outcome measures
| Measure |
M-Trap
n=23 Participants
M-Trap: Device(s) will be surgically implanted in the peritoneal cavity at time of surgical debulking.
|
Platinum Sensitive, Recurrent Patients
Tumor cell capture in at least one device in patients determined to be recurrent and platinum-sensitive
|
Non-recurrent
Tumor cell capture in at least one device in patients who did not demonstrate recurrence
|
All Recurrent Patients
Tumor cell capture in at least one device in patients determined to be recurrent
|
All Patients
Tumor cell capture in at least one device in all patients
|
|---|---|---|---|---|---|
|
Number of Participants With Reasons for Device Removal
Device-related adverse event necessitating removal
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Reasons for Device Removal
Disease progression
|
15 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Reasons for Device Removal
Final 18-month post-implantation time point
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Reasons for Device Removal
Major adverse event not related with the device
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Reasons for Device Removal
Death prior to removal
|
1 Participants
|
—
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: Time of recurrence, an average of 14.5 monthsPopulation: Recurrent patients who underwent successful device removal
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 \[Membrane Quant Module, Panoramic 250 FLASH II 2.0 (3D HISTEC)\].
Outcome measures
| Measure |
M-Trap
n=13 Participants
M-Trap: Device(s) will be surgically implanted in the peritoneal cavity at time of surgical debulking.
|
Platinum Sensitive, Recurrent Patients
Tumor cell capture in at least one device in patients determined to be recurrent and platinum-sensitive
|
Non-recurrent
Tumor cell capture in at least one device in patients who did not demonstrate recurrence
|
All Recurrent Patients
Tumor cell capture in at least one device in patients determined to be recurrent
|
All Patients
Tumor cell capture in at least one device in all patients
|
|---|---|---|---|---|---|
|
Tumor Cell Infiltration
|
1.7 percentage of device
Standard Deviation 2.5
|
—
|
—
|
—
|
—
|
Adverse Events
M-Trap
Serious events: 11 serious events
Other events: 23 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
M-Trap
n=23 participants at risk
M-Trap: Device(s) will be surgically implanted in the peritoneal cavity.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Blood and lymphatic system disorders
Procedural hemorrhage; disseminated intravascular coagulation
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.3%
1/23 • Number of events 2 • 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).
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Gastrointestinal disorders
Intestinal anastomosis complication
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
8.7%
2/23 • Number of events 3 • 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).
|
|
Gastrointestinal disorders
Intestinal perforation
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Gastrointestinal disorders
Pancreatic fistula
|
4.3%
1/23 • Number of events 1 • 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).
|
|
General disorders
Death
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Infections and infestations
Escherichia
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Infections and infestations
Pneumonia
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Infections and infestations
Postoperative wound infection
|
8.7%
2/23 • Number of events 2 • 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).
|
|
Infections and infestations
Pyelonephritis acute
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Infections and infestations
Urinary tract infection
|
8.7%
2/23 • Number of events 3 • 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).
|
|
Injury, poisoning and procedural complications
Post-operative fever
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Injury, poisoning and procedural complications
Post-operative respiratory failure
|
4.3%
1/23 • Number of events 2 • 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).
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Injury, poisoning and procedural complications
Staphylococcal bacteraemia; Intervertebral discitis
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchoplegia
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.7%
2/23 • Number of events 2 • 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).
|
|
Vascular disorders
Distributive shock
|
4.3%
1/23 • Number of events 1 • 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).
|
Other adverse events
| Measure |
M-Trap
n=23 participants at risk
M-Trap: Device(s) will be surgically implanted in the peritoneal cavity.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
39.1%
9/23 • Number of events 12 • 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).
|
|
Gastrointestinal disorders
Vomiting
|
17.4%
4/23 • Number of events 4 • 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).
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
13.0%
3/23 • Number of events 3 • 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).
|
|
Gastrointestinal disorders
Nausea
|
8.7%
2/23 • Number of events 3 • 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).
|
|
Gastrointestinal disorders
Diarrhea
|
8.7%
2/23 • Number of events 2 • 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).
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
8.7%
2/23 • Number of events 2 • 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).
|
|
Gastrointestinal disorders
Umbilical hernia
|
8.7%
2/23 • Number of events 2 • 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).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Injury, poisoning and procedural complications
Procedural hemorrhage
|
56.5%
13/23 • Number of events 13 • 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).
|
|
Injury, poisoning and procedural complications
Neurotoxicity
|
17.4%
4/23 • Number of events 6 • 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).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
8.7%
2/23 • Number of events 2 • 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).
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Injury, poisoning and procedural complications
Contusion
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Injury, poisoning and procedural complications
Postoperative renal failure
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Injury, poisoning and procedural complications
Seroma
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Infections and infestations
Urinary tract infection
|
17.4%
4/23 • Number of events 4 • 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).
|
|
Infections and infestations
Diarrhoea infectious
|
8.7%
2/23 • Number of events 2 • 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).
|
|
Infections and infestations
Bronchitis
|
4.3%
1/23 • Number of events 2 • 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).
|
|
Infections and infestations
Abdominal abscess
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Infections and infestations
Ear infection
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Infections and infestations
Influenza
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Infections and infestations
Postoperative wound infection
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Infections and infestations
Pyelonephritis fungal
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Infections and infestations
Subdiaphragmatic abscess
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Blood and lymphatic system disorders
Anemia
|
17.4%
4/23 • Number of events 5 • 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).
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.0%
3/23 • Number of events 3 • 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).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.7%
2/23 • Number of events 2 • 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).
|
|
General disorders
Asthenia
|
17.4%
4/23 • Number of events 4 • 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).
|
|
General disorders
Chest pain
|
4.3%
1/23 • Number of events 1 • 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).
|
|
General disorders
Condition aggravated
|
4.3%
1/23 • Number of events 1 • 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).
|
|
General disorders
Fatigue
|
4.3%
1/23 • Number of events 1 • 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).
|
|
General disorders
Febrile neutropenia
|
4.3%
1/23 • Number of events 1 • 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).
|
|
General disorders
Influenza like illness
|
4.3%
1/23 • Number of events 1 • 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).
|
|
General disorders
Edema
|
4.3%
1/23 • Number of events 1 • 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).
|
|
General disorders
Edema peripheral
|
4.3%
1/23 • Number of events 1 • 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).
|
|
General disorders
Pyrexia
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.4%
4/23 • Number of events 4 • 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).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.7%
2/23 • Number of events 2 • 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).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Number of events 2 • 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).
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Nervous system disorders
Hypoaesthesia
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Nervous system disorders
Paraesthesia
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Cardiac disorders
Tachycardia
|
8.7%
2/23 • Number of events 2 • 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).
|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Cardiac disorders
Sinus tachycardia
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Vascular disorders
Hemorrhage
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Vascular disorders
Hypertension
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Vascular disorders
Hypotension
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Reproductive system and breast disorders
Breast discharge
|
4.3%
1/23 • Number of events 2 • 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).
|
|
Reproductive system and breast disorders
Ovarian vein thrombosis
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Reproductive system and breast disorders
Vaginal fistula
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Eye disorders
Dry eye
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Eye disorders
Keratitis
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Immune system disorders
Drug hypersensitivity
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Immune system disorders
Hypersensitivity
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Blood and lymphatic system disorders
Anemia; transfusion
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Endocrine disorders
Goitre
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Gastrointestinal disorders
Vomiting; diarrhea
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Investigations
Urine output decreased
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocele
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Psychiatric disorders
Confusional state
|
4.3%
1/23 • Number of events 1 • 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).
|
|
Renal and urinary disorders
Oliguria
|
4.3%
1/23 • Number of events 1 • 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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place