Trial Outcomes & Findings for The EVICEL® Neurosurgery Phase III Study (NCT NCT02457546)
NCT ID: NCT02457546
Last Updated: 2019-01-10
Results Overview
The primary endpoint was the proportion of subjects that had no inter-operative CSF leak following Valsalva maneuver and no CSF leak or pseudomeningocele in the surgical area during the 30-day follow-up period
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
234 participants
Primary outcome timeframe
Intraoperatively through 30-day follow-up
Results posted on
2019-01-10
Participant Flow
Subjects were recruited from medical centers in North America, Europe, and Asia-Pacific. The first subject was randomized on July 7 2015 and the last subject completed the study October 12 2017
Participant milestones
| Measure |
Evicel
EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Fibrinogen (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin, which incorporates calcium.
|
DuraSeal
DuraSeal™ Dural Sealant System is a commercially available synthetic sealant intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. The product is a synthetic absorbable sealant composed of a polyethylene glycol (PEG) ester solution and a rilysine amine solution.
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
120
|
|
Overall Study
COMPLETED
|
105
|
116
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
| Measure |
Evicel
EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Fibrinogen (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin, which incorporates calcium.
|
DuraSeal
DuraSeal™ Dural Sealant System is a commercially available synthetic sealant intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. The product is a synthetic absorbable sealant composed of a polyethylene glycol (PEG) ester solution and a rilysine amine solution.
|
|---|---|---|
|
Overall Study
Other reasons
|
4
|
1
|
|
Overall Study
Refused to complete study/procedures
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
The EVICEL® Neurosurgery Phase III Study
Baseline characteristics by cohort
| Measure |
Evicel
n=114 Participants
EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Fibrinogen (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin, which incorporates calcium.
|
DuraSeal
n=120 Participants
DuraSeal™ Dural Sealant System is a commercially available synthetic sealant intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. The product is a synthetic absorbable sealant composed of a polyethylene glycol (PEG) ester solution and a rilysine amine solution.
|
Total
n=234 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
54.7 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
102 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
BMI
|
27.5 kg/m^2
STANDARD_DEVIATION 6.0 • n=5 Participants
|
26.9 kg/m^2
STANDARD_DEVIATION 5.0 • n=7 Participants
|
27.2 kg/m^2
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
BMI (Grouped)
Underweight
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
BMI (Grouped)
Normal
|
37 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
BMI (Grouped)
Overweight
|
45 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
BMI (Grouped)
Obese
|
27 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
BMI (Grouped)
Morbidly Obese
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity
Hispanic
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity
Non-Hispanic
|
112 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Intraoperatively through 30-day follow-upPopulation: Per Protocol Set
The primary endpoint was the proportion of subjects that had no inter-operative CSF leak following Valsalva maneuver and no CSF leak or pseudomeningocele in the surgical area during the 30-day follow-up period
Outcome measures
| Measure |
Evicel
n=102 Participants
EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Fibrinogen (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin, which incorporates calcium.
|
DuraSeal
n=106 Participants
DuraSeal™ Dural Sealant System is a commercially available synthetic sealant intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. The product is a synthetic absorbable sealant composed of a polyethylene glycol (PEG) ester solution and a rilysine amine solution.
|
|---|---|---|
|
Primary Effectiveness Endpoint Success Number of Successes (Subjects That Had no Inter-operative CSF Leak Following Valsalva Maneuver and no CSF Leak or Pseudomeningocele in the Surgical Area During the 30-day Follow-up Period)
Posterior Fossa
|
22 Participants
|
23 Participants
|
|
Primary Effectiveness Endpoint Success Number of Successes (Subjects That Had no Inter-operative CSF Leak Following Valsalva Maneuver and no CSF Leak or Pseudomeningocele in the Surgical Area During the 30-day Follow-up Period)
Supratentorial
|
73 Participants
|
69 Participants
|
|
Primary Effectiveness Endpoint Success Number of Successes (Subjects That Had no Inter-operative CSF Leak Following Valsalva Maneuver and no CSF Leak or Pseudomeningocele in the Surgical Area During the 30-day Follow-up Period)
Total
|
95 Participants
|
92 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Intraoperatively, after final Valsalva maneuverPopulation: No Valsalva maneuver performed in 2 participants in the Evicel Arm and 1 participant in the DuraSeal Arm
Intra-operative CSF leakage follow final Valsalva
Outcome measures
| Measure |
Evicel
n=112 Participants
EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Fibrinogen (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin, which incorporates calcium.
|
DuraSeal
n=119 Participants
DuraSeal™ Dural Sealant System is a commercially available synthetic sealant intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. The product is a synthetic absorbable sealant composed of a polyethylene glycol (PEG) ester solution and a rilysine amine solution.
|
|---|---|---|
|
Safety Endpoint: Intra-operative CSF Leakage Follow Final Valsalva
|
10 Participants
|
13 Participants
|
Adverse Events
Evicel
Serious events: 32 serious events
Other events: 103 other events
Deaths: 3 deaths
DuraSeal
Serious events: 37 serious events
Other events: 109 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Evicel
n=114 participants at risk
EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Fibrinogen (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin, which incorporates calcium.
|
DuraSeal
n=120 participants at risk
DuraSeal™ Dural Sealant System is a commercially available synthetic sealant intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. The product is a synthetic absorbable sealant composed of a polyethylene glycol (PEG) ester solution and a rilysine amine solution.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Gastrointestinal disorders
Vomiting
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Infections and infestations
Brain empyema
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Infections and infestations
Empyema
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Infections and infestations
Meningitis
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Infections and infestations
Pneumonia
|
3.5%
4/114 • From surgical procedure through the 60 day follow-up visit
|
2.5%
3/120 • From surgical procedure through the 60 day follow-up visit
|
|
Infections and infestations
Postoperative wound infection
|
1.8%
2/114 • From surgical procedure through the 60 day follow-up visit
|
4.2%
5/120 • From surgical procedure through the 60 day follow-up visit
|
|
Infections and infestations
Propionibacterium infection
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Infections and infestations
Sepsis
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
1.8%
2/114 • From surgical procedure through the 60 day follow-up visit
|
7.5%
9/120 • From surgical procedure through the 60 day follow-up visit
|
|
Injury, poisoning and procedural complications
Seroma
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Investigations
White blood cell count increased
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
1.8%
2/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
1.8%
2/114 • From surgical procedure through the 60 day follow-up visit
|
3.3%
4/120 • From surgical procedure through the 60 day follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Aphasia
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Brain oedema
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Cerebral infarction
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
2.6%
3/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Cerebrovascular accident
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Convulsion
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
4.2%
5/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Grand mal convulsion
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Headache
|
1.8%
2/114 • From surgical procedure through the 60 day follow-up visit
|
1.7%
2/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Hydrocephalus
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Subdural hygroma
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Syncope
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
1.7%
2/120 • From surgical procedure through the 60 day follow-up visit
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract oedema
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
1.7%
2/120 • From surgical procedure through the 60 day follow-up visit
|
|
Vascular disorders
Hypertension
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
|
Vascular disorders
Subgaleal haematoma
|
0.88%
1/114 • From surgical procedure through the 60 day follow-up visit
|
0.00%
0/120 • From surgical procedure through the 60 day follow-up visit
|
Other adverse events
| Measure |
Evicel
n=114 participants at risk
EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Fibrinogen (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin, which incorporates calcium.
|
DuraSeal
n=120 participants at risk
DuraSeal™ Dural Sealant System is a commercially available synthetic sealant intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. The product is a synthetic absorbable sealant composed of a polyethylene glycol (PEG) ester solution and a rilysine amine solution.
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
4.4%
5/114 • From surgical procedure through the 60 day follow-up visit
|
5.0%
6/120 • From surgical procedure through the 60 day follow-up visit
|
|
Gastrointestinal disorders
Constipation
|
28.1%
32/114 • From surgical procedure through the 60 day follow-up visit
|
24.2%
29/120 • From surgical procedure through the 60 day follow-up visit
|
|
Gastrointestinal disorders
Nausea
|
28.1%
32/114 • From surgical procedure through the 60 day follow-up visit
|
24.2%
29/120 • From surgical procedure through the 60 day follow-up visit
|
|
Gastrointestinal disorders
Vomiting
|
17.5%
20/114 • From surgical procedure through the 60 day follow-up visit
|
11.7%
14/120 • From surgical procedure through the 60 day follow-up visit
|
|
General disorders
Chest pain
|
4.4%
5/114 • From surgical procedure through the 60 day follow-up visit
|
5.0%
6/120 • From surgical procedure through the 60 day follow-up visit
|
|
General disorders
Fatigue
|
3.5%
4/114 • From surgical procedure through the 60 day follow-up visit
|
5.0%
6/120 • From surgical procedure through the 60 day follow-up visit
|
|
General disorders
Pyrexia
|
2.6%
3/114 • From surgical procedure through the 60 day follow-up visit
|
8.3%
10/120 • From surgical procedure through the 60 day follow-up visit
|
|
Infections and infestations
Pneumonia
|
4.4%
5/114 • From surgical procedure through the 60 day follow-up visit
|
5.0%
6/120 • From surgical procedure through the 60 day follow-up visit
|
|
Infections and infestations
Postoperative wound infection
|
3.5%
4/114 • From surgical procedure through the 60 day follow-up visit
|
5.0%
6/120 • From surgical procedure through the 60 day follow-up visit
|
|
Injury, poisoning and procedural complications
Incision site pain
|
9.6%
11/114 • From surgical procedure through the 60 day follow-up visit
|
10.0%
12/120 • From surgical procedure through the 60 day follow-up visit
|
|
Injury, poisoning and procedural complications
Procedural pain
|
16.7%
19/114 • From surgical procedure through the 60 day follow-up visit
|
15.8%
19/120 • From surgical procedure through the 60 day follow-up visit
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
1.8%
2/114 • From surgical procedure through the 60 day follow-up visit
|
7.5%
9/120 • From surgical procedure through the 60 day follow-up visit
|
|
Injury, poisoning and procedural complications
Wound secretion
|
5.3%
6/114 • From surgical procedure through the 60 day follow-up visit
|
6.7%
8/120 • From surgical procedure through the 60 day follow-up visit
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.1%
7/114 • From surgical procedure through the 60 day follow-up visit
|
0.83%
1/120 • From surgical procedure through the 60 day follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.5%
4/114 • From surgical procedure through the 60 day follow-up visit
|
5.8%
7/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Convulsion
|
2.6%
3/114 • From surgical procedure through the 60 day follow-up visit
|
7.5%
9/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Dizziness
|
4.4%
5/114 • From surgical procedure through the 60 day follow-up visit
|
8.3%
10/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Headache
|
32.5%
37/114 • From surgical procedure through the 60 day follow-up visit
|
45.0%
54/120 • From surgical procedure through the 60 day follow-up visit
|
|
Nervous system disorders
Hemiparesis
|
6.1%
7/114 • From surgical procedure through the 60 day follow-up visit
|
2.5%
3/120 • From surgical procedure through the 60 day follow-up visit
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/114 • From surgical procedure through the 60 day follow-up visit
|
5.8%
7/120 • From surgical procedure through the 60 day follow-up visit
|
|
Vascular disorders
Hypertension
|
10.5%
12/114 • From surgical procedure through the 60 day follow-up visit
|
10.0%
12/120 • From surgical procedure through the 60 day follow-up visit
|
|
Vascular disorders
Hypotension
|
5.3%
6/114 • From surgical procedure through the 60 day follow-up visit
|
6.7%
8/120 • From surgical procedure through the 60 day follow-up visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60