Trial Outcomes & Findings for A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery (NCT NCT04660721)
NCT ID: NCT04660721
Last Updated: 2025-03-21
Results Overview
Incidence of Treatment-Emergent Adverse Events AEs related to bleeding at TBS, thrombotic events, transfusion-related complications, post-operative adhesions (MRI assessment)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
33 participants
Primary outcome timeframe
From visit 1 to visit 9 (an average of 6.5 months)
Results posted on
2025-03-21
Participant Flow
Participant milestones
| Measure |
sFilm-FS
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
Baseline characteristics by cohort
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
63.47 years
STANDARD_DEVIATION 10.46 • n=5 Participants
|
57.81 years
STANDARD_DEVIATION 19.28 • n=7 Participants
|
60.73 years
STANDARD_DEVIATION 15.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Slovenia
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population.
Incidence of Treatment-Emergent Adverse Events AEs related to bleeding at TBS, thrombotic events, transfusion-related complications, post-operative adhesions (MRI assessment)
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ...
Total Number of Treatment-Emergent Adverse Events (TEAE) reported
|
179 number of TEAEs
|
168 number of TEAEs
|
|
To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ...
Related TEAEs
|
0 number of TEAEs
|
0 number of TEAEs
|
|
To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ...
TEAEs leading to discontinuation
|
1 number of TEAEs
|
1 number of TEAEs
|
|
To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ...
Serious TEAEs (SAE)
|
8 number of TEAEs
|
6 number of TEAEs
|
|
To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ...
Non-fatal serious TEAEs
|
7 number of TEAEs
|
5 number of TEAEs
|
|
To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ...
TEAEs leading to death
|
1 number of TEAEs
|
1 number of TEAEs
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by measuring Systolic Blood Pressure (mmHg)
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 1 (Screening) from D-21 to D-1
|
137.1 mmHg
Standard Deviation 12.63
|
129.8 mmHg
Standard Deviation 16.75
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
138.9 mmHg
Standard Deviation 11.89
|
133.0 mmHg
Standard Deviation 11.10
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 3 (Surgery) D0
|
118.9 mmHg
Standard Deviation 20.50
|
111.4 mmHg
Standard Deviation 14.75
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
129.1 mmHg
Standard Deviation 16.97
|
131.4 mmHg
Standard Deviation 21.22
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 5 (Hospital Discharge)
|
133.1 mmHg
Standard Deviation 20.14
|
130.7 mmHg
Standard Deviation 21.08
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
131.6 mmHg
Standard Deviation 13.53
|
123.6 mmHg
Standard Deviation 17.35
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
133.5 mmHg
Standard Deviation 12.52
|
130.0 mmHg
Standard Deviation 15.46
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
130.6 mmHg
Standard Deviation 17.12
|
133.4 mmHg
Standard Deviation 10.34
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
127.0 mmHg
Standard Deviation 19.49
|
134.5 mmHg
Standard Deviation 19.07
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by physical examination: the detection of the number of patients with at least one clinical abnormality in different body areas (abdomen, eyes, skin, cardiovascular)
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations
Visit 1 (Screening) from D-21 to D-1
|
6 number of patients with ≥ 1 abnormality
|
7 number of patients with ≥ 1 abnormality
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations
Visit 5 (Hospital Discharge)
|
3 number of patients with ≥ 1 abnormality
|
5 number of patients with ≥ 1 abnormality
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
6 number of patients with ≥ 1 abnormality
|
5 number of patients with ≥ 1 abnormality
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
4 number of patients with ≥ 1 abnormality
|
5 number of patients with ≥ 1 abnormality
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
6 number of patients with ≥ 1 abnormality
|
5 number of patients with ≥ 1 abnormality
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
6 number of patients with ≥ 1 abnormality
|
4 number of patients with ≥ 1 abnormality
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by urine analysis (pH)
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 1 (Screening) from D-21 to D-1
|
5.5 pH
Standard Deviation 0.60
|
5.9 pH
Standard Deviation 0.84
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
5.7 pH
Standard Deviation 0.59
|
5.9 pH
Standard Deviation 0.88
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 3 (Surgery) D0
|
5.4 pH
Standard Deviation 0.68
|
5.9 pH
Standard Deviation 0.88
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 5 (Hospital Discharge)
|
6.2 pH
Standard Deviation 1.01
|
6.7 pH
Standard Deviation 1.09
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
6.3 pH
Standard Deviation 1.01
|
5.8 pH
Standard Deviation 0.81
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
5.7 pH
Standard Deviation 0.78
|
6.0 pH
Standard Deviation 0.90
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Hemoglobin (g/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
136.1 g/L
Standard Deviation 20.54
|
135.6 g/L
Standard Deviation 14.00
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
138.0 g/L
Standard Deviation 15.13
|
135.0 g/L
Standard Deviation 15.60
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
118.8 g/L
Standard Deviation 10.64
|
121.9 g/L
Standard Deviation 12.74
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
104.5 g/L
Standard Deviation 17.14
|
108.4 g/L
Standard Deviation 15.96
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
106.8 g/L
Standard Deviation 16.19
|
111.7 g/L
Standard Deviation 19.80
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
117.3 g/L
Standard Deviation 17.02
|
122.1 g/L
Standard Deviation 15.45
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
118.8 g/L
Standard Deviation 14.03
|
119.3 g/L
Standard Deviation 14.66
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
126.8 g/L
Standard Deviation 12.66
|
128.9 g/L
Standard Deviation 18.64
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
129.7 g/L
Standard Deviation 11.66
|
136.3 g/L
Standard Deviation 18.77
|
PRIMARY outcome
Timeframe: Last Follow-Up Visit (Visit 9)Safety will be assessed from randomization of patients until the last follow-up visit by Measuring plasma levels of antibodies against human fibrinogen, by performing a screening assay using bridging ELISA based on polyclonal antibodies against human fibrinogen, which was developed with a sensitivity of 1000 ng/ml. Patients whose results were above 1000ng/ml control were considered positive.
Outcome measures
| Measure |
sFilm-FS
n=15 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=13 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Detection of Antibodies Against Fibrinogen.
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by measuring Diastolic Blood Pressure (mmHg)
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 1 (Screening) from D-21 to D-1
|
81.0 mmHg
Standard Deviation 10.59
|
76.0 mmHg
Standard Deviation 7.27
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
75.4 mmHg
Standard Deviation 8.33
|
81.7 mmHg
Standard Deviation 13.61
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 3 (Surgery) D0
|
61.6 mmHg
Standard Deviation 14.60
|
62.3 mmHg
Standard Deviation 10.87
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
74.2 mmHg
Standard Deviation 12.23
|
75.6 mmHg
Standard Deviation 11.52
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 5 (Hospital Discharge)
|
74.9 mmHg
Standard Deviation 9.50
|
79.9 mmHg
Standard Deviation 11.58
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
79.7 mmHg
Standard Deviation 7.90
|
81.6 mmHg
Standard Deviation 8.45
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
80.8 mmHg
Standard Deviation 9.96
|
81.4 mmHg
Standard Deviation 6.88
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
81.0 mmHg
Standard Deviation 11.86
|
82.7 mmHg
Standard Deviation 7.57
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
79.4 mmHg
Standard Deviation 9.58
|
82.3 mmHg
Standard Deviation 11.56
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by measuring Heart Rate (beats/minute)
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 1 (Screening) from D-21 to D-1
|
72.2 beats/minute
Standard Deviation 13.44
|
74.6 beats/minute
Standard Deviation 11.94
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
74.5 beats/minute
Standard Deviation 12.39
|
79.0 beats/minute
Standard Deviation 16.98
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 3 (Surgery) D0
|
69.0 beats/minute
Standard Deviation 19.94
|
79.2 beats/minute
Standard Deviation 13.93
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
77.1 beats/minute
Standard Deviation 11.17
|
80.9 beats/minute
Standard Deviation 18.18
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 5 (Hospital Discharge)
|
79.1 beats/minute
Standard Deviation 11.56
|
84.2 beats/minute
Standard Deviation 14.87
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
77.3 beats/minute
Standard Deviation 16.62
|
78.1 beats/minute
Standard Deviation 17.17
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
74.2 beats/minute
Standard Deviation 14.26
|
83.1 beats/minute
Standard Deviation 8.45
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
73.7 beats/minute
Standard Deviation 10.11
|
74.4 beats/minute
Standard Deviation 7.61
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
73.7 beats/minute
Standard Deviation 16.23
|
73.7 beats/minute
Standard Deviation 13.78
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by measuring Respiratory Rate (breaths/minute)
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 1 (Screening) from D-21 to D-1
|
14.5 breaths/minute
Standard Deviation 3.14
|
13.5 breaths/minute
Standard Deviation 1.83
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
14.5 breaths/minute
Standard Deviation 2.27
|
15.4 breaths/minute
Standard Deviation 2.56
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 3 (Surgery) D0
|
15.8 breaths/minute
Standard Deviation 7.59
|
15.0 breaths/minute
Standard Deviation 3.13
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
15.0 breaths/minute
Standard Deviation 2.88
|
16.8 breaths/minute
Standard Deviation 3.76
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 5 (Hospital Discharge)
|
15.4 breaths/minute
Standard Deviation 3.12
|
22.4 breaths/minute
Standard Deviation 27.55
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
13.7 breaths/minute
Standard Deviation 2.32
|
12.9 breaths/minute
Standard Deviation 1.00
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
13.1 breaths/minute
Standard Deviation 1.81
|
14.3 breaths/minute
Standard Deviation 1.80
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
14.6 breaths/minute
Standard Deviation 2.29
|
13.4 breaths/minute
Standard Deviation 1.41
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
13.6 breaths/minute
Standard Deviation 2.36
|
14.1 breaths/minute
Standard Deviation 1.44
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by measuring Body Temperature (°C)
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 1 (Screening) from D-21 to D-1
|
36.5 °C
Standard Deviation 0.39
|
36.7 °C
Standard Deviation 0.33
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
36.6 °C
Standard Deviation 0.44
|
36.4 °C
Standard Deviation 0.40
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 3 (Surgery) D0
|
36.4 °C
Standard Deviation 0.77
|
36.3 °C
Standard Deviation 0.61
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
36.6 °C
Standard Deviation 0.44
|
36.8 °C
Standard Deviation 0.51
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 5 (Hospital Discharge)
|
36.7 °C
Standard Deviation 0.39
|
36.7 °C
Standard Deviation 0.52
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
36.4 °C
Standard Deviation 0.53
|
36.4 °C
Standard Deviation 0.43
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
36.5 °C
Standard Deviation 0.34
|
36.8 °C
Standard Deviation 0.17
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
36.3 °C
Standard Deviation 0.59
|
36.8 °C
Standard Deviation 0.20
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
36.5 °C
Standard Deviation 0.39
|
36.3 °C
Standard Deviation 0.30
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by urine analysis (Specific Gravity (g/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 1 (Screening) from D-21 to D-1
|
1021.6 g/L
Standard Deviation 9.52
|
1018.8 g/L
Standard Deviation 7.25
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
1017.2 g/L
Standard Deviation 4.65
|
1019.2 g/L
Standard Deviation 8.61
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 3 (Surgery) D0
|
1027.2 g/L
Standard Deviation 11.07
|
1022.4 g/L
Standard Deviation 7.59
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 5 (Hospital Discharge)
|
1018.2 g/L
Standard Deviation 8.94
|
1024.9 g/L
Standard Deviation 21.39
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
1019.9 g/L
Standard Deviation 7.62
|
1019.7 g/L
Standard Deviation 8.96
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
1017.4 g/L
Standard Deviation 6.02
|
1020.1 g/L
Standard Deviation 7.61
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by urine analysis (Presence of Glucose)
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 1 (Screening) from D-21 to D-1
|
6 participants
|
4 participants
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
1 participants
|
0 participants
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 3 (Surgery) D0
|
5 participants
|
4 participants
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 5 (Hospital Discharge)
|
7 participants
|
4 participants
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
5 participants
|
4 participants
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
0 participants
|
0 participants
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
0 participants
|
0 participants
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
2 participants
|
3 participants
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Mean Cell Hemoglobin Concentration (g/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
337.3 g/L
Standard Deviation 15.40
|
337.5 g/L
Standard Deviation 11.83
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
335.5 g/L
Standard Deviation 8.14
|
337.5 g/L
Standard Deviation 8.40
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
338.3 g/L
Standard Deviation 12.16
|
337.7 g/L
Standard Deviation 12.56
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
336.6 g/L
Standard Deviation 10.82
|
333.8 g/L
Standard Deviation 11.41
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
335.9 g/L
Standard Deviation 10.53
|
333.6 g/L
Standard Deviation 12.87
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
322.6 g/L
Standard Deviation 12.02
|
332.1 g/L
Standard Deviation 12.48
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
324.9 g/L
Standard Deviation 11.02
|
326.7 g/L
Standard Deviation 16.71
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
329.8 g/L
Standard Deviation 11.91
|
326.6 g/L
Standard Deviation 8.88
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
329.9 g/L
Standard Deviation 10.77
|
334.9 g/L
Standard Deviation 15.16
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Mean Cell Hemoglobin (pg))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
29.8 pg
Standard Deviation 3.00
|
29.5 pg
Standard Deviation 2.27
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
31.3 pg
Standard Deviation 2.01
|
28.2 pg
Standard Deviation 2.22
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
30.4 pg
Standard Deviation 1.95
|
29.3 pg
Standard Deviation 2.17
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
30.1 pg
Standard Deviation 2.11
|
29.6 pg
Standard Deviation 2.05
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
30.1 pg
Standard Deviation 1.81
|
29.3 pg
Standard Deviation 2.45
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
28.7 pg
Standard Deviation 2.26
|
29.1 pg
Standard Deviation 2.89
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
28.7 pg
Standard Deviation 2.38
|
27.5 pg
Standard Deviation 3.00
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
28.8 pg
Standard Deviation 3.26
|
27.1 pg
Standard Deviation 3.10
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
29.4 pg
Standard Deviation 2.53
|
29.6 pg
Standard Deviation 3.27
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Mean Corpuscular Volume (fL))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
88.5 fL
Standard Deviation 6.83
|
87.8 fL
Standard Deviation 7.34
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
93.1 fL
Standard Deviation 4.70
|
84.3 fL
Standard Deviation 8.21
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
90.4 fL
Standard Deviation 5.84
|
86.8 fL
Standard Deviation 6.91
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
89.5 fL
Standard Deviation 5.62
|
88.9 fL
Standard Deviation 6.35
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
89.9 fL
Standard Deviation 4.51
|
87.6 fL
Standard Deviation 7.31
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
88.9 fL
Standard Deviation 5.43
|
87.9 fL
Standard Deviation 8.29
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
88.5 fL
Standard Deviation 6.51
|
84.3 fL
Standard Deviation 8.79
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
86.9 fL
Standard Deviation 7.83
|
82.9 fL
Standard Deviation 8.30
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
88.2 fL
Standard Deviation 6.96
|
88.8 fL
Standard Deviation 9.02
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Red Blood Cell (10\^12cells/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
4.6 10^12cells/L
Standard Deviation 0.57
|
4.6 10^12cells/L
Standard Deviation 0.53
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
4.4 10^12cells/L
Standard Deviation 0.40
|
4.8 10^12cells/L
Standard Deviation 0.57
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
3.9 10^12cells/L
Standard Deviation 0.41
|
4.2 10^12cells/L
Standard Deviation 0.57
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
3.5 10^12cells/L
Standard Deviation 0.58
|
3.7 10^12cells/L
Standard Deviation 0.63
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
3.6 10^12cells/L
Standard Deviation 0.61
|
3.8 10^12cells/L
Standard Deviation 0.66
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
4.1 10^12cells/L
Standard Deviation 0.58
|
4.2 10^12cells/L
Standard Deviation 0.52
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
4.1 10^12cells/L
Standard Deviation 0.43
|
4.4 10^12cells/L
Standard Deviation 0.52
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
4.4 10^12cells/L
Standard Deviation 0.34
|
4.8 10^12cells/L
Standard Deviation 0.63
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
4.5 10^12cells/L
Standard Deviation 0.31
|
4.6 10^12cells/L
Standard Deviation 0.71
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (White Blood Cell (10\^9cells/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
6.3 10^9cells/L
Standard Deviation 2.56
|
8.0 10^9cells/L
Standard Deviation 2.24
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
7.2 10^9cells/L
Standard Deviation 2.47
|
8.0 10^9cells/L
Standard Deviation 2.58
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
8.1 10^9cells/L
Standard Deviation 2.00
|
9.2 10^9cells/L
Standard Deviation 3.21
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
11.9 10^9cells/L
Standard Deviation 3.81
|
10.9 10^9cells/L
Standard Deviation 6.43
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
6.43 10^9cells/L
Standard Deviation 4.61
|
12.1 10^9cells/L
Standard Deviation 6.26
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
8.2 10^9cells/L
Standard Deviation 2.93
|
9.6 10^9cells/L
Standard Deviation 5.23
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
6.8 10^9cells/L
Standard Deviation 2.33
|
8.1 10^9cells/L
Standard Deviation 2.01
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
6.2 10^9cells/L
Standard Deviation 3.20
|
7.4 10^9cells/L
Standard Deviation 2.47
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
8.4 10^9cells/L
Standard Deviation 4.42
|
7.8 10^9cells/L
Standard Deviation 1.53
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Platelet (10\^9cells/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
241.6 10^9cells/L
Standard Deviation 104.69
|
278.7 10^9cells/L
Standard Deviation 90.90
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
241.6 10^9cells/L
Standard Deviation 82.68
|
308.2 10^9cells/L
Standard Deviation 125.23
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
227.4 10^9cells/L
Standard Deviation 100.21
|
275.0 10^9cells/L
Standard Deviation 122.16
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
238.4 10^9cells/L
Standard Deviation 104.66
|
312.6 10^9cells/L
Standard Deviation 173.32
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
308.4 10^9cells/L
Standard Deviation 153.07
|
403.5 10^9cells/L
Standard Deviation 272.79
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
260.9 10^9cells/L
Standard Deviation 111.99
|
330.1 10^9cells/L
Standard Deviation 189.33
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
216.8 10^9cells/L
Standard Deviation 114.38
|
397.3 10^9cells/L
Standard Deviation 204.51
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
203.8 10^9cells/L
Standard Deviation 115.82
|
342.9 10^9cells/L
Standard Deviation 169.86
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
250.2 10^9cells/L
Standard Deviation 98.07
|
276.4 10^9cells/L
Standard Deviation 141.69
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Fibrinogen (g/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
4.9 g/L
Standard Deviation 1.21
|
5.8 g/L
Standard Deviation 2.48
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
4.1 g/L
Standard Deviation 1.16
|
4.3 g/L
Standard Deviation 1.88
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
3.8 g/L
Standard Deviation 0.87
|
4.3 g/L
Standard Deviation 0.82
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
3.0 g/L
Standard Deviation 0.81
|
3.5 g/L
Standard Deviation 0.63
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
5.2 g/L
Standard Deviation 1.10
|
5.8 g/L
Standard Deviation 2.46
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
4.7 g/L
Standard Deviation 1.68
|
4.4 g/L
Standard Deviation 1.88
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
3.7 g/L
Standard Deviation 0.75
|
4.6 g/L
Standard Deviation 2.05
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
3.6 g/L
Standard Deviation 0.95
|
3.6 g/L
Standard Deviation 0.71
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
3.8 g/L
Standard Deviation 0.96
|
3.2 g/L
Standard Deviation 0.47
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (D-Dimer (microg/mL))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
1.1 microg/mL
Standard Deviation 0.81
|
0.9 microg/mL
Standard Deviation 0.90
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
0.8 microg/mL
Standard Deviation 0.46
|
1.3 microg/mL
Standard Deviation 1.51
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
3.8 microg/mL
Standard Deviation 3.58
|
2.8 microg/mL
Standard Deviation 2.57
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
5.0 microg/mL
Standard Deviation 3.32
|
3.3 microg/mL
Standard Deviation 1.76
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
4.8 microg/mL
Standard Deviation 4.54
|
4.9 microg/mL
Standard Deviation 3.69
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
2.3 microg/mL
Standard Deviation 1.78
|
2.2 microg/mL
Standard Deviation 3.09
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
1.1 microg/mL
Standard Deviation 0.68
|
1.3 microg/mL
Standard Deviation 1.33
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
1.2 microg/mL
Standard Deviation 1.05
|
0.6 microg/mL
Standard Deviation 0.30
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
1.4 microg/mL
Standard Deviation 2.03
|
4.0 microg/mL
Standard Deviation 11.25
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Erythrocyte Sedimentation Rate (mm/hr))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
18.3 mm/hr
Standard Deviation 11.60
|
23.7 mm/hr
Standard Deviation 18.44
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
20.6 mm/hr
Standard Deviation 14.29
|
21.9 mm/hr
Standard Deviation 6.85
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
17.6 mm/hr
Standard Deviation 12.87
|
18.9 mm/hr
Standard Deviation 13.30
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
48.5 mm/hr
Standard Deviation 25.46
|
53.7 mm/hr
Standard Deviation 37.18
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
55.7 mm/hr
Standard Deviation 31.99
|
61.9 mm/hr
Standard Deviation 41.07
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
39.8 mm/hr
Standard Deviation 28.87
|
55.1 mm/hr
Standard Deviation 51.17
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
16.5 mm/hr
Standard Deviation 10.56
|
46.9 mm/hr
Standard Deviation 37.53
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
18.0 mm/hr
Standard Deviation 14.13
|
28.1 mm/hr
Standard Deviation 18.64
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
17.7 mm/hr
Standard Deviation 13.24
|
18.0 mm/hr
Standard Deviation 9.86
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (C-Reactive Protein (mg/dL))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
0.8 mg/dL
Standard Deviation 1.31
|
1.0 mg/dL
Standard Deviation 1.17
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
0.5 mg/dL
Standard Deviation 0.47
|
0.4 mg/dL
Standard Deviation 0.14
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
0.6 mg/dL
Standard Deviation 0.86
|
0.5 mg/dL
Standard Deviation 0.35
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
2.6 mg/dL
Standard Deviation 4.97
|
1.6 mg/dL
Standard Deviation 2.02
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
1.1 mg/dL
Standard Deviation 1.11
|
1.3 mg/dL
Standard Deviation 2.30
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
1.2 mg/dL
Standard Deviation 1.46
|
0.9 mg/dL
Standard Deviation 0.66
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
0.7 mg/dL
Standard Deviation 0.90
|
0.7 mg/dL
Standard Deviation 0.48
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
8.2 mg/dL
Standard Deviation 8.91
|
11.4 mg/dL
Standard Deviation 10.02
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
5.6 mg/dL
Standard Deviation 5.35
|
5.5 mg/dL
Standard Deviation 6.64
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Blood Urea Nitrogen (mmol/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
5.3 mmol/L
Standard Deviation 1.58
|
5.2 mmol/L
Standard Deviation 1.28
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
5.8 mmol/L
Standard Deviation 1.09
|
4.6 mmol/L
Standard Deviation 2.03
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
5.1 mmol/L
Standard Deviation 1.34
|
4.7 mmol/L
Standard Deviation 1.98
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
5.2 mmol/L
Standard Deviation 3.98
|
4.9 mmol/L
Standard Deviation 2.49
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
4.7 mmol/L
Standard Deviation 2.14
|
4.3 mmol/L
Standard Deviation 1.73
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
5.1 mmol/L
Standard Deviation 2.08
|
4.6 mmol/L
Standard Deviation 1.65
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
5.7 mmol/L
Standard Deviation 1.53
|
4.1 mmol/L
Standard Deviation 1.38
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
5.5 mmol/L
Standard Deviation 1.32
|
4.7 mmol/L
Standard Deviation 1.55
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
4.2 mmol/L
Standard Deviation 1.42
|
4.2 mmol/L
Standard Deviation 2.31
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Creatinine (micromol/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
73.6 micromol/L
Standard Deviation 18.12
|
61.7 micromol/L
Standard Deviation 11.56
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
82.1 micromol/L
Standard Deviation 21.02
|
68.9 micromol/L
Standard Deviation 10.62
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
71.9 micromol/L
Standard Deviation 18.48
|
66.5 micromol/L
Standard Deviation 19.42
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
67.6 micromol/L
Standard Deviation 34.13
|
58.7 micromol/L
Standard Deviation 19.73
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
66.7 micromol/L
Standard Deviation 19.76
|
59.8 micromol/L
Standard Deviation 14.82
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
69.0 micromol/L
Standard Deviation 16.50
|
60.0 micromol/L
Standard Deviation 7.58
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
71.7 micromol/L
Standard Deviation 16.01
|
62.7 micromol/L
Standard Deviation 13.46
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
73.4 micromol/L
Standard Deviation 21.88
|
65.9 micromol/L
Standard Deviation 15.73
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
72.4 micromol/L
Standard Deviation 17.81
|
61.6 micromol/L
Standard Deviation 9.91
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Uric Acid (micromol/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
434.0 micromol/L
Standard Deviation 324.04
|
376.1 micromol/L
Standard Deviation 306.72
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
320.4 micromol/L
Standard Deviation 84.22
|
346.5 micromol/L
Standard Deviation 102.24
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
534.2 micromol/L
Standard Deviation 585.91
|
401.1 micromol/L
Standard Deviation 296.09
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
505.9 micromol/L
Standard Deviation 550.82
|
304.8 micromol/L
Standard Deviation 153.16
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
426.7 micromol/L
Standard Deviation 423.50
|
343.7 micromol/L
Standard Deviation 210.83
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
358.1 micromol/L
Standard Deviation 307.01
|
431.3 micromol/L
Standard Deviation 435.82
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
317.9 micromol/L
Standard Deviation 87.80
|
340.0 micromol/L
Standard Deviation 59.81
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
321.4 micromol/L
Standard Deviation 90.98
|
338.1 micromol/L
Standard Deviation 124.09
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
401.6 micromol/L
Standard Deviation 345.94
|
312.4 micromol/L
Standard Deviation 111.15
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Total Bilirubin (micromol/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
10.9 micromol/L
Standard Deviation 6.71
|
12.0 micromol/L
Standard Deviation 6.93
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
10.8 micromol/L
Standard Deviation 7.62
|
11.6 micromol/L
Standard Deviation 4.63
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
18.5 micromol/L
Standard Deviation 15.69
|
11.6 micromol/L
Standard Deviation 6.25
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
16.9 micromol/L
Standard Deviation 19.88
|
13.1 micromol/L
Standard Deviation 12.01
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
9.8 micromol/L
Standard Deviation 6.61
|
8.0 micromol/L
Standard Deviation 4.57
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
9.4 micromol/L
Standard Deviation 5.11
|
7.1 micromol/L
Standard Deviation 2.51
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
8.7 micromol/L
Standard Deviation 5.89
|
6.7 micromol/L
Standard Deviation 2.15
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
10.1 micromol/L
Standard Deviation 5.55
|
7.9 micromol/L
Standard Deviation 5.51
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
11.0 micromol/L
Standard Deviation 7.60
|
11.3 micromol/L
Standard Deviation 6.10
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Lactate Dehydrogenase (microkat/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
3.7 microkat/L
Standard Deviation 0.68
|
3.9 microkat/L
Standard Deviation 2.28
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
3.6 microkat/L
Standard Deviation 0.50
|
3.4 microkat/L
Standard Deviation 0.75
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
8.1 microkat/L
Standard Deviation 6.18
|
5.5 microkat/L
Standard Deviation 2.72
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
4.8 microkat/L
Standard Deviation 2.30
|
4.6 microkat/L
Standard Deviation 1.29
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
4.0 microkat/L
Standard Deviation 0.92
|
4.5 microkat/L
Standard Deviation 1.19
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
3.5 microkat/L
Standard Deviation 0.64
|
3.6 microkat/L
Standard Deviation 0.90
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
3.6 microkat/L
Standard Deviation 0.44
|
3.7 microkat/L
Standard Deviation 1.01
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
3.3 microkat/L
Standard Deviation 1.63
|
3.0 microkat/L
Standard Deviation 1.60
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
2.9 microkat/L
Standard Deviation 0.83
|
3.1 microkat/L
Standard Deviation 1.08
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Serum Glutamic Oxaloacetic Transaminase/Aspartate Aminotransferase (microkat/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
0.6 microkat/L
Standard Deviation 0.29
|
0.4 microkat/L
Standard Deviation 0.23
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
0.5 microkat/L
Standard Deviation 0.21
|
0.4 microkat/L
Standard Deviation 0.11
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
4.2 microkat/L
Standard Deviation 4.42
|
1.8 microkat/L
Standard Deviation 1.58
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
2.3 microkat/L
Standard Deviation 3.42
|
1.2 microkat/L
Standard Deviation 1.07
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
0.7 microkat/L
Standard Deviation 0.34
|
0.9 microkat/L
Standard Deviation 0.62
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
0.5 microkat/L
Standard Deviation 0.22
|
0.4 microkat/L
Standard Deviation 0.14
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
0.5 microkat/L
Standard Deviation 0.30
|
0.5 microkat/L
Standard Deviation 0.16
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
0.5 microkat/L
Standard Deviation 0.31
|
0.4 microkat/L
Standard Deviation 0.24
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
0.5 microkat/L
Standard Deviation 0.21
|
0.5 microkat/L
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Serum Glutamic Pyruvic Transaminase/Alanine Aminotransferase (microkat/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
0.6 microkat/L
Standard Deviation 0.47
|
0.4 microkat/L
Standard Deviation 0.23
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
0.4 microkat/L
Standard Deviation 0.22
|
0.5 microkat/L
Standard Deviation 0.17
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
3.2 microkat/L
Standard Deviation 3.53
|
1.4 microkat/L
Standard Deviation 1.34
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
2.9 microkat/L
Standard Deviation 3.86
|
1.4 microkat/L
Standard Deviation 1.53
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
0.8 microkat/L
Standard Deviation 0.58
|
1.4 microkat/L
Standard Deviation 1.28
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
0.7 microkat/L
Standard Deviation 1.09
|
0.4 microkat/L
Standard Deviation 0.23
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
0.5 microkat/L
Standard Deviation 0.41
|
0.4 microkat/L
Standard Deviation 0.23
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
0.5 microkat/L
Standard Deviation 0.31
|
0.4 microkat/L
Standard Deviation 0.14
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
0.5 microkat/L
Standard Deviation 0.30
|
0.4 microkat/L
Standard Deviation 0.20
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Gamma-GT (microkat/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
2.9 microkat/L
Standard Deviation 7.82
|
1.1 microkat/L
Standard Deviation 1.10
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
0.6 microkat/L
Standard Deviation 0.33
|
0.8 microkat/L
Standard Deviation 1.20
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
2.8 microkat/L
Standard Deviation 7.85
|
0.7 microkat/L
Standard Deviation 0.89
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
4.7 microkat/L
Standard Deviation 7.43
|
1.1 microkat/L
Standard Deviation 0.91
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
3.0 microkat/L
Standard Deviation 6.16
|
1.7 microkat/L
Standard Deviation 1.23
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
3.8 microkat/L
Standard Deviation 7.12
|
1.3 microkat/L
Standard Deviation 0.96
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
0.8 microkat/L
Standard Deviation 0.82
|
0.8 microkat/L
Standard Deviation 0.91
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
0.8 microkat/L
Standard Deviation 0.95
|
0.8 microkat/L
Standard Deviation 0.85
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
1.2 microkat/L
Standard Deviation 1.18
|
0.9 microkat/L
Standard Deviation 1.01
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Sodium (mmol/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
139.4 mmol/L
Standard Deviation 3.38
|
140.6 mmol/L
Standard Deviation 3.07
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
141.1 mmol/L
Standard Deviation 2.26
|
139.9 mmol/L
Standard Deviation 1.89
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
140.0 mmol/L
Standard Deviation 3.59
|
139.0 mmol/L
Standard Deviation 3.89
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
140.9 mmol/L
Standard Deviation 2.72
|
139.8 mmol/L
Standard Deviation 2.63
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
139.1 mmol/L
Standard Deviation 3.19
|
139.7 mmol/L
Standard Deviation 2.85
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
140.9 mmol/L
Standard Deviation 2.00
|
139.1 mmol/L
Standard Deviation 2.41
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
141.5 mmol/L
Standard Deviation 2.54
|
139.9 mmol/L
Standard Deviation 2.41
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
140.8 mmol/L
Standard Deviation 2.10
|
140.5 mmol/L
Standard Deviation 2.78
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
140.3 mmol/L
Standard Deviation 1.62
|
140.6 mmol/L
Standard Deviation 2.79
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Calcium (mmol/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
2.1 mmol/L
Standard Deviation 0.11
|
2.1 mmol/L
Standard Deviation 0.11
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
2.2 mmol/L
Standard Deviation 0.16
|
2.2 mmol/L
Standard Deviation 0.13
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
2.4 mmol/L
Standard Deviation 0.16
|
2.4 mmol/L
Standard Deviation 0.10
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
2.4 mmol/L
Standard Deviation 0.16
|
2.4 mmol/L
Standard Deviation 0.09
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
2.4 mmol/L
Standard Deviation 0.10
|
2.3 mmol/L
Standard Deviation 0.16
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
2.4 mmol/L
Standard Deviation 0.11
|
2.3 mmol/L
Standard Deviation 0.12
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
2.1 mmol/L
Standard Deviation 0.14
|
2.1 mmol/L
Standard Deviation 0.12
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
2.5 mmol/L
Standard Deviation 0.45
|
3.0 mmol/L
Standard Deviation 1.93
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
2.4 mmol/L
Standard Deviation 0.11
|
2.4 mmol/L
Standard Deviation 0.05
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Phosphorous (mmol/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
1.0 mmol/L
Standard Deviation 0.12
|
1.1 mmol/L
Standard Deviation 0.21
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
1.2 mmol/L
Standard Deviation 0.08
|
1.1 mmol/L
Standard Deviation 0.16
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
1.2 mmol/L
Standard Deviation 0.20
|
1.1 mmol/L
Standard Deviation 0.33
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
0.9 mmol/L
Standard Deviation 0.32
|
0.9 mmol/L
Standard Deviation 0.24
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
1.0 mmol/L
Standard Deviation 0.19
|
1.0 mmol/L
Standard Deviation 0.30
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
1.1 mmol/L
Standard Deviation 0.11
|
1.1 mmol/L
Standard Deviation 0.19
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
1.1 mmol/L
Standard Deviation 0.28
|
1.1 mmol/L
Standard Deviation 0.17
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
1.0 mmol/L
Standard Deviation 0.24
|
1.1 mmol/L
Standard Deviation 0.15
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
1.2 mmol/L
Standard Deviation 0.20
|
8.7 mmol/L
Standard Deviation 28.57
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Glucose (mmol/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
8.1 mmol/L
Standard Deviation 2.50
|
7.6 mmol/L
Standard Deviation 2.65
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
6.5 mmol/L
Standard Deviation 2.51
|
5.6 mmol/L
Standard Deviation 1.27
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
6.7 mmol/L
Standard Deviation 3.15
|
6.4 mmol/L
Standard Deviation 3.78
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
6.1 mmol/L
Standard Deviation 1.91
|
6.5 mmol/L
Standard Deviation 2.23
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
6.4 mmol/L
Standard Deviation 1.62
|
6.0 mmol/L
Standard Deviation 1.50
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
6.2 mmol/L
Standard Deviation 1.52
|
5.9 mmol/L
Standard Deviation 1.91
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
5.9 mmol/L
Standard Deviation 1.59
|
6.9 mmol/L
Standard Deviation 3.83
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
5.2 mmol/L
Standard Deviation 1.73
|
7.1 mmol/L
Standard Deviation 5.50
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
6.0 mmol/L
Standard Deviation 1.83
|
5.7 mmol/L
Standard Deviation 3.37
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Albumin (g/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
32.4 g/L
Standard Deviation 5.25
|
34.0 g/L
Standard Deviation 6.81
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
42.9 g/L
Standard Deviation 4.38
|
44.6 g/L
Standard Deviation 5.01
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
43.2 g/L
Standard Deviation 4.71
|
43.8 g/L
Standard Deviation 4.92
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
42.4 g/L
Standard Deviation 4.16
|
42.5 g/L
Standard Deviation 5.67
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
42.6 g/L
Standard Deviation 3.89
|
44.0 g/L
Standard Deviation 4.99
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
32.8 g/L
Standard Deviation 4.77
|
34.5 g/L
Standard Deviation 4.95
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
28.6 g/L
Standard Deviation 4.71
|
30.7 g/L
Standard Deviation 5.08
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
40.0 g/L
Standard Deviation 3.35
|
41.1 g/L
Standard Deviation 4.85
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
41.7 g/L
Standard Deviation 2.95
|
41.9 g/L
Standard Deviation 3.93
|
PRIMARY outcome
Timeframe: From visit 1 to visit 9 (an average of 6.5 months)Population: Descriptive Analysis on Safety Population
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Total Protein (g/L))
Outcome measures
| Measure |
sFilm-FS
n=17 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 3 (Surgery) D0
|
56.6 g/L
Standard Deviation 8.07
|
62.0 g/L
Standard Deviation 8.83
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 2 (Baseline) to be skipped in case Visit 1 is performed one day before surgery (D-1)
|
71.1 g/L
Standard Deviation 5.41
|
74.9 g/L
Standard Deviation 8.89
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 4 (Post-Surgery) Daily from D1 to Day of Hospital Discharge
|
54.9 g/L
Standard Deviation 8.68
|
60.5 g/L
Standard Deviation 10.16
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 5 (Hospital Discharge)
|
63.2 g/L
Standard Deviation 9.92
|
64.5 g/L
Standard Deviation 9.60
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 6 (Follow-up Day 30) D30 (±3) from Visit 3
|
75.0 g/L
Standard Deviation 6.53
|
76.1 g/L
Standard Deviation 9.44
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 7 (Follow-up Day 60) D60 (±7) from Visit 3
|
72.4 g/L
Standard Deviation 4.99
|
79.3 g/L
Standard Deviation 8.28
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 9 (Follow-up Day 180) D180 (±14) from Visit 3
|
74.8 g/L
Standard Deviation 6.21
|
75.3 g/L
Standard Deviation 5.42
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 8 (Follow-up Day 120) D120 (±14) from Visit 3
|
75.1 g/L
Standard Deviation 6.15
|
77.7 g/L
Standard Deviation 8.10
|
|
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
Visit 1 (Screening) from D-21 to D-1
|
73.2 g/L
Standard Deviation 5.93
|
73.0 g/L
Standard Deviation 9.29
|
SECONDARY outcome
Timeframe: Day of surgeryProportion of patients achieving hemostasis at TBS (absence of bleeding) at 2 (for sFilm-FS product only), 3, 5, 7 or 10 minutes following first product application, without the occurrence of re-bleeding, starting from 10 minutes after product application and until the completion of surgical closure
Outcome measures
| Measure |
sFilm-FS
n=14 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=12 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS
2 minutes after application (only for sFilm-FS)
|
11 Participants
|
0 Participants
|
|
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS
10 minutes after application
|
14 Participants
|
12 Participants
|
|
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS
3 minutes after application
|
12 Participants
|
12 Participants
|
|
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS
5 minutes after application
|
12 Participants
|
12 Participants
|
|
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS
7 minutes after application
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day of surgeryPopulation: Descriptive statistics of all randomized patients who underwent surgery, received at least one dose of study treatment and having no major violations of inclusion and exclusion criteria
Incidence of re-treatment (one or more additional patch of sFilm-FS or TACHOSIL®) at the TBS at the different time points (2 for sFilm-FS, 3, 5, 7, 10 minutes from first product application)
Outcome measures
| Measure |
sFilm-FS
n=14 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=12 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS
2 minutes after application (only for sFilm-FS)
|
0 Participants
|
0 Participants
|
|
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS
3 minutes after application
|
0 Participants
|
0 Participants
|
|
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS
5 minutes after application
|
0 Participants
|
0 Participants
|
|
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS
7 minutes after application
|
0 Participants
|
0 Participants
|
|
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS
10 minutes after application
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day of surgeryPopulation: Descriptive statistics of all randomized patients who underwent surgery, received at least one dose of study treatment and having no major violations of inclusion and exclusion criteria
Percentage of total patients (patients that achieved hemostasis with a single patch application and patients that required additional patches) that have achieved hemostasis 10 minutes after first product application and therefore did not need to convert to standard of care treatment at the end of these 10 minutes
Outcome measures
| Measure |
sFilm-FS
n=14 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=12 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Percentage of Total Patients That Have Achieved Hemostasis
|
14 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day of surgeryPopulation: Descriptive statistics of all randomized patients who underwent surgery, received at least one dose of study treatment and having no major violations of inclusion and exclusion criteria
Incidence of treatment failure, based on pre-defined treatment failure criteria (in case the bleeding at TBS (or re-bleeding) is still observed after 10 minutes following first application of study product; if hemostasis at TBS is achieved, but the Investigator decides that an additional treatment is required to ensure the durability of hemostasis; if there is a breakthrough bleeding requiring treatment other than the study product, at any time)
Outcome measures
| Measure |
sFilm-FS
n=14 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=12 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through Incidence of Treatment Failure
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From surgery, up to 6 monthsPopulation: Descriptive statistics of all randomized patients who underwent surgery, received at least one dose of study treatment and having no major violations of inclusion and exclusion criteria
Incidence of transfusion requirements in the 6 months follow-up period
Outcome measures
| Measure |
sFilm-FS
n=14 Participants
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=12 Participants
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure.
|
1 participants
|
1 participants
|
Adverse Events
sFilm-FS
Serious events: 6 serious events
Other events: 17 other events
Deaths: 1 deaths
TACHOSIL®
Serious events: 5 serious events
Other events: 16 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
sFilm-FS
n=17 participants at risk
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 participants at risk
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
ABDOMINAL WALL HAEMATOMA
|
11.8%
2/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
General disorders
DISEASE PROGRESSION
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
General disorders
IMPAIRED HEALING
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Metabolism and nutrition disorders
MALNUTRITON
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE AROPHY
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
Other adverse events
| Measure |
sFilm-FS
n=17 participants at risk
sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
|
TACHOSIL®
n=16 participants at risk
TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
11.8%
2/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Blood and lymphatic system disorders
BLOOD LOSS ANAEMIA
|
11.8%
2/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Blood and lymphatic system disorders
COAGULOPATHY
|
11.8%
2/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Blood and lymphatic system disorders
IRON DEFICIENTY ANAEMIA
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Blood and lymphatic system disorders
SPLENIC INFARCTION
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Blood and lymphatic system disorders
THROMBOCYTOSIS
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Cardiac disorders
AORTIC VALVE INCOMPETENCE
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
11.8%
2/17 • Number of events 3 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Cardiac disorders
ATRIAL TACHYCARDIA
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Cardiac disorders
COR PULMONALE
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Cardiac disorders
CARDIOMEGALY
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Cardiac disorders
PERICARDIAL CYST
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Cardiac disorders
RIGHT VENTRICULAR ENLARGEMENT
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Cardiac disorders
RIGHT VENTRICULA FAILURE
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
11.8%
2/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Cardiac disorders
SYSTOLIC DYSFUNCTION
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Cardiac disorders
TACHYCARDIA
|
5.9%
1/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
18.8%
3/16 • Number of events 4 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Cardiac disorders
TRICUSPID VALVE INCOMPETENCE
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Cardiac disorders
VENTRICULA EXTRASYSTOLES
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Cardiac disorders
VENTRICULAR HYPOKINESIA
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Congenital, familial and genetic disorders
FACTOR II DEFICIENCY
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Ear and labyrinth disorders
VERTIGO
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
12.5%
2/16 • Number of events 3 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
11.8%
2/17 • Number of events 3 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
11.8%
2/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
ABDOMINAL WALL HAEMATOMA
|
11.8%
2/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
12.5%
2/16 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
ABNORMAL FAECES
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
CONSTIPATION
|
17.6%
3/17 • Number of events 3 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
DIARRHOEA
|
11.8%
2/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
12.5%
2/16 • Number of events 5 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
DUODENITIS
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
GASTRIC ILEUS
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
INFLAMMATORY BOWEL DISEASE
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
INTRA ABDOMINAL HAEMATOMA
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
NAUSEA
|
70.6%
12/17 • Number of events 14 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
31.2%
5/16 • Number of events 5 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Gastrointestinal disorders
VOMITING
|
11.8%
2/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
General disorders
ASTHENIA
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
General disorders
CHEST PAIN
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
General disorders
DEATH
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
General disorders
DISEASE PROGRESSION
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
General disorders
FATIGUE
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
General disorders
GENERALISED OEDEMA
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
General disorders
IMPAIRED HEALING
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
General disorders
INFLAMMATORY PAIN
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
General disorders
OEDEMA PERIPHERAL
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
12.5%
2/16 • Number of events 5 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
General disorders
PAIN
|
17.6%
3/17 • Number of events 4 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
31.2%
5/16 • Number of events 11 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
General disorders
PYREXIA
|
11.8%
2/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
18.8%
3/16 • Number of events 3 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Hepatobiliary disorders
HEPATORENAL FAILURE
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
5.9%
1/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Hepatobiliary disorders
HYPERTRANSAMINASAEMIA
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Infections and infestations
ABDOMINAL INFECTION
|
11.8%
2/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Infections and infestations
BACTERIAL INFECTION
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Infections and infestations
CANDIDA INFECTION
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Infections and infestations
COVID-19
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Infections and infestations
INFECTION SUSCEPTIBILITY INCREASED
|
5.9%
1/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
5.9%
1/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
11.8%
2/17 • Number of events 3 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
18.8%
3/16 • Number of events 5 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Injury, poisoning and procedural complications
CONFUSION
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Injury, poisoning and procedural complications
DRAIN SITE COMPLICATION
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Injury, poisoning and procedural complications
FALL
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Injury, poisoning and procedural complications
HEPATIC SEROMA
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL BILE LEAK
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL BILE LEAK
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Injury, poisoning and procedural complications
PROCEDURAL HYPOTENSION
|
17.6%
3/17 • Number of events 3 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
64.7%
11/17 • Number of events 13 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
56.2%
9/16 • Number of events 11 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Injury, poisoning and procedural complications
SEROMA
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Injury, poisoning and procedural complications
WOUND
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
12.5%
2/16 • Number of events 3 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Investigations
BLOOD ALBUMIN INCREASED
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Investigations
BLOOD BILIRUBIN INCREASE
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Investigations
GAMMA GLUTAMYLTRANSFERASE INCREASED
|
5.9%
1/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
5.9%
1/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Metabolism and nutrition disorders
FOLATE DEFICIENCY
|
5.9%
1/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
12.5%
2/16 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
12.5%
2/16 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
47.1%
8/17 • Number of events 12 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
31.2%
5/16 • Number of events 5 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Metabolism and nutrition disorders
HYPOPHAGIA
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
17.6%
3/17 • Number of events 4 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
18.8%
3/16 • Number of events 3 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Metabolism and nutrition disorders
MAGNESIUM DEFICIENCY
|
29.4%
5/17 • Number of events 5 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
11.8%
2/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DEGENERATION
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE ATRHOPHY
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADRENAL GLAND CANCER
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHOLANGIOCARCINOMA
|
11.8%
2/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GALLBLADDER CANCER
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
12.5%
2/16 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAEMANGIOMA OF SPLEEN
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LUNG
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEUROENDOCRINE CARCINOMA METASTATIC
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
12.5%
2/16 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
12.5%
2/16 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Nervous system disorders
POLYNEUROPATHY
|
5.9%
1/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Nervous system disorders
RADICULOPATHY
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Psychiatric disorders
AGITATION
|
11.8%
2/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Psychiatric disorders
ANXIETY
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Psychiatric disorders
DEPRESSION
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Psychiatric disorders
INSOMNIA
|
11.8%
2/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Psychiatric disorders
RESTLESSNESS
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Psychiatric disorders
SLEEP DISORDER
|
17.6%
3/17 • Number of events 3 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
12.5%
2/16 • Number of events 3 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
11.8%
2/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
18.8%
3/16 • Number of events 3 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Renal and urinary disorders
OLIGURIA
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Renal and urinary disorders
RENAL INFARCT
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Reproductive system and breast disorders
GENITAL HAEMORRHAGE
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Reproductive system and breast disorders
PENILE HAEMATOMA
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Reproductive system and breast disorders
PENILE PAIN
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
18.8%
3/16 • Number of events 3 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
5.9%
1/17 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
18.8%
3/16 • Number of events 3 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
12.5%
2/16 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Skin and subcutaneous tissue disorders
EXCESSIVE GRANULATION TISSUE
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Skin and subcutaneous tissue disorders
LIPODYSTROPHY ACQUIRED
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Skin and subcutaneous tissue disorders
PRURITUS ALLERGIC
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Surgical and medical procedures
BLOOD VOLUME EXPANSION
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Surgical and medical procedures
COLONIC LAVAGE
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Surgical and medical procedures
DERMABRASION
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Surgical and medical procedures
HAEMATOMA EVACUATION
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Surgical and medical procedures
PROPHYLAXIS
|
5.9%
1/17 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
0.00%
0/16 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Vascular disorders
HYPERTENSION
|
17.6%
3/17 • Number of events 3 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
12.5%
2/16 • Number of events 2 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Vascular disorders
HYPOTENSION
|
11.8%
2/17 • Number of events 3 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
12.5%
2/16 • Number of events 5 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
|
Vascular disorders
INFERIOR VENA CAVA DILATATION
|
0.00%
0/17 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
6.2%
1/16 • Number of events 1 • From Visit 1 to Visit 9 (an average of 6.5 months). All SAE assessed by the Investigator as related to the study drug were continuing to be followed up until 30 days following last visit of the study or until SAE was resolved or stabilized.
Adverse events, especially those related to the study drug were followed up until resolution (returned to baseline status) or stabilization. All AEs were followed-up even after the patient's participation in the study was completed, or in case of withdrawal of the patient from the clinical trial or of anticipated conclusion of the study.
|
Additional Information
Prof. Orgad Laub, Chief Executive Officer
Sealantium Medical Ltd.
Phone: +972 0544434387
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place