Trial Outcomes & Findings for Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding (NCT NCT02640235)
NCT ID: NCT02640235
Last Updated: 2020-08-03
Results Overview
Hemostasis is a process to prevent and stop bleeding within damaged blood vessels. Once the product(s) is applied it absorbs blood, turns brown, and adheres to the wound, thereby preventing thrombocytes from being washed out and accelerating hemostasis. Target bleeding sites include mild to moderate parenchymal (organ tissue),vascular (small arteries or veins or surgical reconnections) and soft tissue (muscle, fat, ligament, connective tissue) bleeding.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
260 participants
Primary outcome timeframe
5 minute (post-application)
Results posted on
2020-08-03
Participant Flow
Participant milestones
| Measure |
CELSTAT
Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site
CELSTAT
|
Surgicel Original
Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site
Surgicel Original
|
|---|---|---|
|
Overall Study
STARTED
|
131
|
129
|
|
Overall Study
COMPLETED
|
117
|
115
|
|
Overall Study
NOT COMPLETED
|
14
|
14
|
Reasons for withdrawal
| Measure |
CELSTAT
Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site
CELSTAT
|
Surgicel Original
Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site
Surgicel Original
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
6
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Death
|
2
|
3
|
|
Overall Study
Other
|
1
|
2
|
Baseline Characteristics
Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding
Baseline characteristics by cohort
| Measure |
CELSTAT
n=126 Participants
Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site
CELSTAT
|
Surgicel Original
n=124 Participants
Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site
Surgicel Original
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 12.88 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 13.56 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 13.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
108 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Applicable
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 minute (post-application)Population: PPS
Hemostasis is a process to prevent and stop bleeding within damaged blood vessels. Once the product(s) is applied it absorbs blood, turns brown, and adheres to the wound, thereby preventing thrombocytes from being washed out and accelerating hemostasis. Target bleeding sites include mild to moderate parenchymal (organ tissue),vascular (small arteries or veins or surgical reconnections) and soft tissue (muscle, fat, ligament, connective tissue) bleeding.
Outcome measures
| Measure |
CELSTAT
n=126 Participants
Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site
CELSTAT
|
Surgicel Original
n=124 Participants
Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site
Surgicel Original
|
|---|---|---|
|
Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application
Yes
|
94 Participants
|
109 Participants
|
|
Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application
No
|
32 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 91Population: Safety Analysis Set - all subjects who were treated with CELSTAT or Surgicel.
Findings are reported in this outcome measure and would have also been reported as an AE.
Outcome measures
| Measure |
CELSTAT
n=133 Participants
Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site
CELSTAT
|
Surgicel Original
n=127 Participants
Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site
Surgicel Original
|
|---|---|---|
|
Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 to 10 minutes (post-application)Population: PPS
Data presented is an interpretation of a Kaplan-Meier plot based on quartiles of the survival distribution estimate. "Survival" times need not relate to actual survival with death being the event; the "event" may be any event of interest. The Kaplan-Meier curves and estimates of survival data have become a familiar way of dealing with differing survival times (times-to-event).
Outcome measures
| Measure |
CELSTAT
n=126 Participants
Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site
CELSTAT
|
Surgicel Original
n=124 Participants
Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site
Surgicel Original
|
|---|---|---|
|
Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants
75% of Patients
|
6 minutes
Interval 3.25 to 7.0
|
4 minutes
Interval 3.17 to 5.0
|
|
Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants
50% of Patients
|
2 minutes
Interval 2.0 to 3.0
|
3 minutes
Interval 2.0 to 3.0
|
|
Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants
25% of Patients
|
0.833 minutes
Interval 0.58 to 1.0
|
1.292 minutes
Interval 0.83 to 2.0
|
SECONDARY outcome
Timeframe: 3 minutes (post application)Population: PPS
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
Outcome measures
| Measure |
CELSTAT
n=126 Participants
Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site
CELSTAT
|
Surgicel Original
n=124 Participants
Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site
Surgicel Original
|
|---|---|---|
|
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application
Yes
|
84 Participants
|
79 Participants
|
|
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application
No
|
42 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: 7 minutes (post application)Population: PPS
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
Outcome measures
| Measure |
CELSTAT
n=126 Participants
Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site
CELSTAT
|
Surgicel Original
n=124 Participants
Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site
Surgicel Original
|
|---|---|---|
|
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application
Yes
|
108 Participants
|
118 Participants
|
|
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application
No
|
18 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 10 minutes (post application)Population: PPS
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
Outcome measures
| Measure |
CELSTAT
n=126 Participants
Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site
CELSTAT
|
Surgicel Original
n=124 Participants
Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site
Surgicel Original
|
|---|---|---|
|
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application
Yes
|
119 Participants
|
120 Participants
|
|
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application
No
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 0 to 10 minutes (post-application)Population: PPS
If intraoperative re-bleeding occurred, the primary endpoint was considered "treatment failure."
Outcome measures
| Measure |
CELSTAT
n=126 Participants
Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site
CELSTAT
|
Surgicel Original
n=124 Participants
Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site
Surgicel Original
|
|---|---|---|
|
Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis
Yes
|
3.3 Percentage of Participants
|
2.5 Percentage of Participants
|
|
Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis
No
|
96.7 Percentage of Participants
|
97.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 91Population: Safety Analysis Set
Adverse Events (AEs) that occurred after the start of study treatment application are referred to as "treatment-emergent AEs" (TEAE). Timeframe for tracking AE's up to Day 91 (minus/plus 10 days=from Day 81 to Day 101).
Outcome measures
| Measure |
CELSTAT
n=133 Participants
Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site
CELSTAT
|
Surgicel Original
n=127 Participants
Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site
Surgicel Original
|
|---|---|---|
|
Number of Occurrences of Treatment Emergent Adverse Events (Serious and Non-Serious)
|
289 events
|
244 events
|
Adverse Events
CELSTAT
Serious events: 27 serious events
Other events: 72 other events
Deaths: 2 deaths
Surgicel Original
Serious events: 23 serious events
Other events: 68 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
CELSTAT
n=133 participants at risk
Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site
CELSTAT
|
Surgicel Original
n=127 participants at risk
Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site
Surgicel Original
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Angina Pectoris
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
2.4%
3/127 • Number of events 3 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Bradycardia
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Cardiac Arrest
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Pulseless Electrical Activity
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Enterovesical Fistula
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Chest Pain
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Impaired Healing
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Multi-Organ Failure
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Pyrexia
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Thrombosis In Device
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Cellulitis
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Pneumonia
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Sepsis
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Urinary Tract Infection
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Postoperative Thoracic Procedure Complication
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Vascular Graft Occlusion
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Vascular Graft Thrombosis
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma Metastatic
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Liver
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Nervous system disorders
Partial Seizures
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Nervous system disorders
Syncope
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Nervous system disorders
Tremor
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Vascular disorders
Aortic Occlusion
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Vascular disorders
Lymphorrhoea
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Vascular disorders
Peripheral Arterial Occlusive
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Vascular disorders
Peripheral Artery Stenosis
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
Other adverse events
| Measure |
CELSTAT
n=133 participants at risk
Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site
CELSTAT
|
Surgicel Original
n=127 participants at risk
Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site
Surgicel Original
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
5/133 • Number of events 5 • Day 1 up to Day 101
Safety Analysis Set used.
|
4.7%
6/127 • Number of events 6 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Atrial Fibrillation
|
12.0%
16/133 • Number of events 16 • Day 1 up to Day 101
Safety Analysis Set used.
|
10.2%
13/127 • Number of events 13 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Bradycardia
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Cardiac Tamponade
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Nodal Rhythm
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Tachycardia
|
2.3%
3/133 • Number of events 3 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Ear and labyrinth disorders
Vertigo
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Abdominal Mass
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Acquired Oesophageal Web
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Constipation
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
3.9%
5/127 • Number of events 5 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
6/133 • Number of events 6 • Day 1 up to Day 101
Safety Analysis Set used.
|
2.4%
3/127 • Number of events 3 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Diverticulum
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Dysphagia
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
2.4%
3/127 • Number of events 3 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
2.3%
3/133 • Number of events 3 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Nausea
|
6.8%
9/133 • Number of events 9 • Day 1 up to Day 101
Safety Analysis Set used.
|
3.1%
4/127 • Number of events 4 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Asthenia
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Catheter Site Pain
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Chest Pain
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
3.1%
4/127 • Number of events 4 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Device Leakage
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Device Occlusion
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Fatigue
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Hyperthermia
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Impaired Healing
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Implant Site Pain
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Implant Site Swelling
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Mucosal Inflammation
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Oedema Peripheral
|
2.3%
3/133 • Number of events 3 • Day 1 up to Day 101
Safety Analysis Set used.
|
2.4%
3/127 • Number of events 3 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Peripheral Swelling
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Polyp
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Pyrexia
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
General disorders
Stent-Graft Endoleak
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Hepatobiliary disorders
Ischaemic Hepatitis
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Immune system disorders
Drug Hypersensitivity
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Bronchitis
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Endometritis
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Fungal Skin Infection
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Gastritis Viral
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Gastrointestinal Infection
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Groin Infection
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Implant Site Infection
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Incision Site Infection
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Liver Abscess
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Oral Candidiasis
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Oral Fungal Infection
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Post Procedural Cellulitis
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Postoperative Abscess
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Postoperative Wound Infection
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Soft Tissue Infection
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Urinary Tract Infection
|
3.0%
4/133 • Number of events 4 • Day 1 up to Day 101
Safety Analysis Set used.
|
4.7%
6/127 • Number of events 6 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Infections and infestations
Wound Infection
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Anaemia Postoperative
|
3.0%
4/133 • Number of events 4 • Day 1 up to Day 101
Safety Analysis Set used.
|
3.1%
4/127 • Number of events 4 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Corneal Abrasion
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Incision Site Erythema
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Incision Site Swelling
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Inflammation Of Wound
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Post Procedural Discharge
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Postoperative Ileus
|
2.3%
3/133 • Number of events 3 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Postoperative Wound Complication
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Procedural Dizziness
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Procedural Haemorrhage
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Procedural Hypotension
|
3.0%
4/133 • Number of events 4 • Day 1 up to Day 101
Safety Analysis Set used.
|
4.7%
6/127 • Number of events 6 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Wound
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Wound Haematoma
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Investigations
Anticoagulation Drug Level Below Therapeutic
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Investigations
Blood Gases Abnormal
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Investigations
Blood Parathyroid Hormone Increased
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Investigations
Blood Potassium Decreased
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Investigations
Blood Urea Increased
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Investigations
Breath Sounds Abnormal
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Investigations
Cardiac Index Decreased
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Investigations
Heart Rate Increased
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Investigations
Transaminases Increased
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Investigations
Urine Output Decreased
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Investigations
Weight Decreased
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Investigations
White Blood Cell Count Increased
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
2.4%
3/127 • Number of events 3 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.3%
3/133 • Number of events 3 • Day 1 up to Day 101
Safety Analysis Set used.
|
2.4%
3/127 • Number of events 3 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
7/133 • Number of events 7 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.3%
3/133 • Number of events 3 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.0%
4/133 • Number of events 4 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Nervous system disorders
Dizziness
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Nervous system disorders
Dysgeusia
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Nervous system disorders
Headache
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Nervous system disorders
Hypoaesthesia
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Nervous system disorders
Hypoglossal Nerve Disorder
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Nervous system disorders
Neuralgia
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Nervous system disorders
Paraesthesia
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
2.4%
3/127 • Number of events 3 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Nervous system disorders
Restless Legs Syndrome
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Psychiatric disorders
Anxiety
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Psychiatric disorders
Delirium
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Psychiatric disorders
Depression
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Psychiatric disorders
Insomnia
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.0%
4/133 • Number of events 4 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Renal and urinary disorders
Calculus Bladder
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Renal and urinary disorders
Haematuria
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Renal and urinary disorders
Renal Cyst
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Renal and urinary disorders
Urinary Retention
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
2.4%
3/127 • Number of events 3 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Reproductive system and breast disorders
Epididymal Tenderness
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Reproductive system and breast disorders
Scrotal Swelling
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
3.1%
4/127 • Number of events 4 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
4/133 • Number of events 4 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
4.5%
6/133 • Number of events 6 • Day 1 up to Day 101
Safety Analysis Set used.
|
4.7%
6/127 • Number of events 6 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
3.1%
4/127 • Number of events 4 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
1.6%
2/127 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Skin and subcutaneous tissue disorders
Pruritus Allergic
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.5%
2/133 • Number of events 2 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Vascular disorders
Haematoma
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Vascular disorders
Hypertension
|
3.8%
5/133 • Number of events 5 • Day 1 up to Day 101
Safety Analysis Set used.
|
3.1%
4/127 • Number of events 4 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Vascular disorders
Hypotension
|
2.3%
3/133 • Number of events 3 • Day 1 up to Day 101
Safety Analysis Set used.
|
2.4%
3/127 • Number of events 3 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Vascular disorders
Hypovolaemic Shock
|
0.75%
1/133 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.00%
0/127 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
|
Vascular disorders
Vasodilatation
|
0.00%
0/133 • Day 1 up to Day 101
Safety Analysis Set used.
|
0.79%
1/127 • Number of events 1 • Day 1 up to Day 101
Safety Analysis Set used.
|
Additional Information
Clinical Trials Disclosure Group
Baxter Healthcare Corporation
Phone: (224) 948-7359
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place