Trial Outcomes & Findings for Feasibility Study on the Contribution of Guided Puncture With Echoendoscopy (NCT NCT01892501)
NCT ID: NCT01892501
Last Updated: 2025-09-03
Results Overview
The performance of EUS-guided biopsy has been evaluated in terms of sensitivity. EUS-guided was performed after detection of lymph nodes with positron emission tomography (PET). In most cases, only one lymph node is taken and performance analysis will be done by patient and not by injury. PET, the reference technique (gold standard), is followed for 12 months. Sensitivity is the rate of subjects with a diagnosis of malignancy (excluding the results atypical / suspicious or non-contributory) according the results of EUS among all subjects with a neoplastic disease by the gold reference. To sum up , the sensitivity corresponds to the rate of patients detected as "malignant" with the new technique (EUS-guided), among the patients detected as "malignant" at the reference PET examination (12 months assessment).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
12 months
Results posted on
2025-09-03
Participant Flow
Participant milestones
| Measure |
Hypermetabolic Mediastinal Lymph Nodes in PET,
Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.
Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion.
Pathological samples are taken :
3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken.
PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
Group A : Biopsy Surgically Possible
|
72
|
|
Overall Study
Group B : Biopsy Not Surgically Possible
|
3
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Hypermetabolic Mediastinal Lymph Nodes in PET,
Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.
Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion.
Pathological samples are taken :
3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken.
PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts
|
|---|---|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Puncture not carried out
|
9
|
|
Overall Study
Radiological monitoring not carried out
|
5
|
|
Overall Study
Non-contributory histological result
|
12
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hypermetabolic Mediastinal Lymph Nodes in PET,
n=75 Participants
Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.
Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion.
Pathological samples are taken :
3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken.
PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts
|
|---|---|
|
Age, Continuous
|
63.01 years
STANDARD_DEVIATION 13.64 • n=75 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=75 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=75 Participants
|
|
Height
|
166.97 cm
STANDARD_DEVIATION 8.67 • n=75 Participants
|
|
Weight
|
72.53 kg
STANDARD_DEVIATION 16.46 • n=75 Participants
|
|
Therapeutic strategy (absence of documentation)
Not available
|
1 Participants
n=75 Participants
|
|
Therapeutic strategy (absence of documentation)
Surgery right from the start
|
4 Participants
n=75 Participants
|
|
Therapeutic strategy (absence of documentation)
Chemotherapy or other carcinological treatment
|
54 Participants
n=75 Participants
|
|
Therapeutic strategy (absence of documentation)
Non-carcinological management in case of documented benign pathology
|
12 Participants
n=75 Participants
|
|
Therapeutic strategy (absence of documentation)
No treatment
|
4 Participants
n=75 Participants
|
|
Therapeutic strategy after documentation
Missing
|
8 Participants
n=41 Participants • missing data
|
|
Therapeutic strategy after documentation
Chemotherapy or other carcinological treatment
|
20 Participants
n=41 Participants • missing data
|
|
Therapeutic strategy after documentation
No treatment
|
13 Participants
n=41 Participants • missing data
|
|
T status (Classification of Malignant Tumors)
T0
|
1 Participants
n=37 Participants • missing data
|
|
T status (Classification of Malignant Tumors)
T1
|
7 Participants
n=37 Participants • missing data
|
|
T status (Classification of Malignant Tumors)
T2
|
9 Participants
n=37 Participants • missing data
|
|
T status (Classification of Malignant Tumors)
T3
|
13 Participants
n=37 Participants • missing data
|
|
T status (Classification of Malignant Tumors)
T4
|
5 Participants
n=37 Participants • missing data
|
|
T status (Classification of Malignant Tumors)
TX
|
2 Participants
n=37 Participants • missing data
|
|
N status (Classification of Malignant Tumors)
Missing
|
6 Participants
n=37 Participants • Patients with available TNM status
|
|
N status (Classification of Malignant Tumors)
N0
|
11 Participants
n=37 Participants • Patients with available TNM status
|
|
N status (Classification of Malignant Tumors)
N+
|
17 Participants
n=37 Participants • Patients with available TNM status
|
|
N status (Classification of Malignant Tumors)
NX
|
3 Participants
n=37 Participants • Patients with available TNM status
|
|
M status (Classification of Malignant Tumors)
Missing
|
5 Participants
n=37 Participants • Patients with available TNM status
|
|
M status (Classification of Malignant Tumors)
M0
|
17 Participants
n=37 Participants • Patients with available TNM status
|
|
M status (Classification of Malignant Tumors)
M1
|
2 Participants
n=37 Participants • Patients with available TNM status
|
|
M status (Classification of Malignant Tumors)
Could not be evaluated for distant metastases
|
13 Participants
n=37 Participants • Patients with available TNM status
|
|
Total number of lymph nodes per patient
|
3.00 lymph nodes
n=75 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Patient eligible and evaluable for primary endpoint (N=47) (excluded patients with non-contributory histological results, puncture not carried out, radiological monitoring not carried out)
The performance of EUS-guided biopsy has been evaluated in terms of sensitivity. EUS-guided was performed after detection of lymph nodes with positron emission tomography (PET). In most cases, only one lymph node is taken and performance analysis will be done by patient and not by injury. PET, the reference technique (gold standard), is followed for 12 months. Sensitivity is the rate of subjects with a diagnosis of malignancy (excluding the results atypical / suspicious or non-contributory) according the results of EUS among all subjects with a neoplastic disease by the gold reference. To sum up , the sensitivity corresponds to the rate of patients detected as "malignant" with the new technique (EUS-guided), among the patients detected as "malignant" at the reference PET examination (12 months assessment).
Outcome measures
| Measure |
Hypermetabolic Mediastinal Lymph Nodes in PET,
n=47 Participants
Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.
Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion.
Pathological samples are taken :
3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken.
PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts
|
|---|---|
|
Sensitivity of Endoscopic Ultrasound-guided (EUS-guided) Puncture
|
93 percentage
Interval 76.0 to 99.0
|
SECONDARY outcome
Timeframe: 12 monthsThe negative predictive value of EUS-guided biopsy has been evaluated by the rate of subjects with a diagnosis of benign pathology according the gold standard (PET) among all subjects for wich EUS reveal a benign pathology (excluding atypical/suspects findings or non contributory)
Outcome measures
| Measure |
Hypermetabolic Mediastinal Lymph Nodes in PET,
n=47 Participants
Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.
Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion.
Pathological samples are taken :
3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken.
PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts
|
|---|---|
|
Negative Predictive Value
|
90 percentage
Interval 71.0 to 99.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Patients eligible and evaluable with available pre (before endoscopy results) AND post documentation (after endoscopy results) therapeutic strategies. Of note, 6 patients without therapeutic strategies after endoscopy results.
Impact of the management of patient : Concordance between therapeutic strategies before the results of the endoscopy (Multidisciplinary consultation meeting 1 (RCP1) in absence of documentation) and after the results of endoscopy (Multidisciplinary consultation meeting 2 (RCP2) post-documentation) for the eligible and evaluable population
Outcome measures
| Measure |
Hypermetabolic Mediastinal Lymph Nodes in PET,
n=41 Participants
Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.
Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion.
Pathological samples are taken :
3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken.
PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts
|
|---|---|
|
Matching Between Therapeutic Strategies RCP1/RCP2
|
44.7 percentage of patients
Interval 30.2 to 59.9
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Patients evaluable for clinical utility
The clinical utility of puncture under echo-endoscopy puncture has been considered to have a clinical utility, if it allows the patient to avoid more invasive diagnostic procedures (mediastinoscopy or thoracoscopy) or if it allows the patient to benefit from appropriate treatment (result of the malignant biopsy) or to avoid receiving unjustified treatment (result of the benign biopsy): case of patients well classified as malignant/benign by puncture under echo-endoscopy. The puncture will be considered to have no clinical utility if the result of the puncture under echo-endoscopy is invalidated by the reference examination, or if the result of the puncture does not allow a diagnosis to be made.
Outcome measures
| Measure |
Hypermetabolic Mediastinal Lymph Nodes in PET,
n=47 Participants
Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.
Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion.
Pathological samples are taken :
3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken.
PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts
|
|---|---|
|
Clinical Utility (Avoid More Invasive Procedure)
|
95.7 percentage of patients
Interval 85.46 to 99.48
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Patients with at least one adverse event with Dindo classification (N=38)
In all cases the side effects associated with the implementation of the guided puncture EUS has been collected and classified according to the classification of surgical complications of Clavien-Dindo \[P Clavien and al. Ann Surg 2009, 250: 187-96\]. Classification of surgical complications of Clavien-Dindo ranges from grade 1 (any deviation from the normal postoperative course) to grade 5 (death of patient)
Outcome measures
| Measure |
Hypermetabolic Mediastinal Lymph Nodes in PET,
n=68 Number of adverse event
Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.
Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion.
Pathological samples are taken :
3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken.
PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts
|
|---|---|
|
Side Effects - Number of Adverse Event Declared According to DINDO Classification
Not available
|
54 Number of adverse event per grade
|
|
Side Effects - Number of Adverse Event Declared According to DINDO Classification
I
|
6 Number of adverse event per grade
|
|
Side Effects - Number of Adverse Event Declared According to DINDO Classification
II
|
2 Number of adverse event per grade
|
|
Side Effects - Number of Adverse Event Declared According to DINDO Classification
IIIb
|
6 Number of adverse event per grade
|
Adverse Events
Hypermetabolic Mediastinal Lymph Nodes in PET,
Serious events: 34 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hypermetabolic Mediastinal Lymph Nodes in PET,
n=47 participants at risk
Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.
Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion.
Pathological samples are taken :
3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken.
PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.4%
3/47 • Number of events 3 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Cardiac disorders
Heart failure
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Gastrointestinal disorders
Ascites
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
8.5%
4/47 • Number of events 4 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Infections and infestations
Kidney infection
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Investigations
Platelet count decreased
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
23.4%
11/47 • Number of events 11 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
4.3%
2/47 • Number of events 2 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
Other adverse events
| Measure |
Hypermetabolic Mediastinal Lymph Nodes in PET,
n=47 participants at risk
Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.
Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion.
Pathological samples are taken :
3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken.
PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts
|
|---|---|
|
Gastrointestinal disorders
Left inguinal hernia aggravation
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
General disorders
Alteration of the general condition
|
8.5%
4/47 • Number of events 4 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Blood and lymphatic system disorders
Anemia
|
6.4%
3/47 • Number of events 3 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Blood and lymphatic system disorders
Ferriprive anemia on melena
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Blood and lymphatic system disorders
Multifactorial anemia
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Blood and lymphatic system disorders
Febrile aplasia
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
General disorders
Asthenia
|
6.4%
3/47 • Number of events 3 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Nervous system disorders
Ataxia
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Nervous system disorders
Headaches
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Musculoskeletal and connective tissue disorders
Cervicalgies
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Surgery for liver metastases
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Nervous system disorders
Hypoglycemic coma
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Nervous system disorders
Right cruralgia
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cryotherapy for pleuropulmonary metastases
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Removal of the left cervical lymph node
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Hepatobiliary disorders
Oedemato-ascitic decompensation
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Nervous system disorders
Dysesthesia
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Nervous system disorders
Right foot dysesthesia
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Nervous system disorders
Dysphony
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Respiratory, thoracic and mediastinal disorders
Acute dyspney
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Renal and urinary disorders
Dysury
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Vascular disorders
Pulmonary embolisme
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
2/47 • Number of events 2 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral pleural effusion
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
General disorders
Febrile episode
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Cardiac disorders
Extra systole
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Injury, poisoning and procedural complications
Fracture of the left pubic ramus
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Renal and urinary disorders
Hematury
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysia
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Vascular disorders
Hemorragia
|
8.5%
4/47 • Number of events 4 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Infections and infestations
Hepatite C
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Metabolism and nutrition disorders
Hyperkalemy
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Cardiac disorders
Congestive heart failure
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Renal and urinary disorders
Kidney failure
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Renal and urinary disorders
Acute renal failure
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasmus
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebrale mestastases
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Gastrointestinal disorders
Mucite
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Infections and infestations
Mycosis
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Infections and infestations
Lingual mycosis
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Nervous system disorders
Neuropathy
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
General disorders
Oedeme
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Gastrointestinal disorders
Oesophagite
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Respiratory, thoracic and mediastinal disorders
Chest tightness
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal kystic mesotheliome
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
General disorders
Disease progression
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
General disorders
Symptomatoc intramedullary progression
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
General disorders
Tumoral progression
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Infections and infestations
Pyelonephrite with E.COLI and enterobactery
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung metastasis resection + lymph nodes
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinite
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Infections and infestations
Sepsis of probable urinary origin
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Cardiac disorders
Cave syndrome and jugular thrombosis
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Musculoskeletal and connective tissue disorders
Vertebral compression
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Investigations
Thrombopenia
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Eye disorders
Xerophthalmia
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Gastrointestinal disorders
Ascites
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
|
Gastrointestinal disorders
Aggravation left inguinal hernia
|
2.1%
1/47 • Number of events 1 • Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
|
Additional Information
Dr. Dominique Bechade, Coordinating Investigator
Institute Bergonie
Phone: 0556337805
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place