Trial Outcomes & Findings for Safety and Efficacy of CERE-120 in Subjects With Parkinson's Disease (NCT NCT00985517)
NCT ID: NCT00985517
Last Updated: 2020-04-16
Results Overview
Number of Participants who received CERE-120 Treatment
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
57 participants
Primary outcome timeframe
5 years
Results posted on
2020-04-16
Participant Flow
Participant milestones
| Measure |
Phase 1: Cohort 1
CERE-120 at 9.4 x 10\^11 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 1: Cohort 2
CERE-120 at 2.4 x 10\^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 2: CERE-120 Treatment Group
CERE-120 at 2.4 x 10\^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 2: Sham Surgery
Neurosurgical procedure that mimics the procedure for CERE-120 delivery. No injections are performed during sham surgery.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
24
|
27
|
|
Overall Study
COMPLETED
|
3
|
3
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of CERE-120 in Subjects With Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Phase 1: Cohort 1
n=3 Participants
CERE-120 at 9.4 x 10\^11 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 1: Cohort 2
n=3 Participants
CERE-120 at 2.4 x 10\^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 2: CERE-120
n=24 Participants
CERE-120 at 2.4 x 10\^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 2: Sham Surgery
n=27 Participants
Neurosurgical procedure that mimics the procedure for CERE-120 delivery. No injections are performed during sham surgery.
|
Total
n=57 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Age, Continuous
|
44.9 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
55.4 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
58.2 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
58.0 years
STANDARD_DEVIATION 7.0 • n=4 Participants
|
57.4 years
STANDARD_DEVIATION 7.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
24 participants
n=5 Participants
|
27 participants
n=4 Participants
|
57 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Phase 1: Cohort 1, Phase 1: Cohort 2, Phase 2: CERE-120, Phase 2: Sham Surgery
Number of Participants who received CERE-120 Treatment
Outcome measures
| Measure |
Phase 1: Cohort 1
n=3 Participants
CERE-120 at 9.4 x 10\^11 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 1: Cohort 2
n=3 Participants
CERE-120 at 2.4 x 10\^12, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 2: CERE-120
n=24 Participants
CERE-120 at 2.4 x 10\^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 2: Sham Surgery
n=27 Participants
Neurosurgical procedure that mimics the procedure for CERE-120 delivery. No injections are performed during sham surgery.
|
|---|---|---|---|---|
|
Number of Participants Who Received CERE-120 Treatment
|
3 Participants
|
3 Participants
|
24 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Months 15, 18, 21 and 24UPDRS is a tool to evaluate the impact of symptomatic and potential disease modifying treatments. Part III focuses on 14 motor functions, assessing each on a scale from 0 (normal) to 4 (severe) with total score 0 - 56. The 5 Feb 2003 version of the UPDRS Rating was used in this trial. The total score is the sum of 14 motor functions. Change from baseline in total score is reported. The last double blind assessment for each subject is defined as the most recent assessment at the time when the final randomized subject completes the Month 15 Visit. The length of the double-blind follow-up period for each subject ranged from 15 to 24 months, depending on the enrollment rate.
Outcome measures
| Measure |
Phase 1: Cohort 1
n=3 Participants
CERE-120 at 9.4 x 10\^11 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 1: Cohort 2
n=3 Participants
CERE-120 at 2.4 x 10\^12, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 2: CERE-120
n=24 Participants
CERE-120 at 2.4 x 10\^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 2: Sham Surgery
n=27 Participants
Neurosurgical procedure that mimics the procedure for CERE-120 delivery. No injections are performed during sham surgery.
|
|---|---|---|---|---|
|
Phase 1 and Phase 2: Change From Baseline in Motor Examination Part III Total Score in the "Off" Condition for the CERE-120 Group as Compared to the Sham Surgery Control Group at the Last Double-blind Assessment.
MONTH 15
|
NA score on a scale
Not a protocol specified timepoint
|
NA score on a scale
Not a protocol specified timepoint
|
-5.04 score on a scale
Interval -26.0 to 12.0
|
-5.09 score on a scale
Interval -26.0 to 13.0
|
|
Phase 1 and Phase 2: Change From Baseline in Motor Examination Part III Total Score in the "Off" Condition for the CERE-120 Group as Compared to the Sham Surgery Control Group at the Last Double-blind Assessment.
MONTH 18
|
-3.67 score on a scale
Interval -5.0 to -2.0
|
-7.33 score on a scale
Interval -9.0 to -4.0
|
-5.21 score on a scale
Interval -29.0 to 14.0
|
-3.78 score on a scale
Interval -24.0 to 15.0
|
|
Phase 1 and Phase 2: Change From Baseline in Motor Examination Part III Total Score in the "Off" Condition for the CERE-120 Group as Compared to the Sham Surgery Control Group at the Last Double-blind Assessment.
MONTH 21
|
NA score on a scale
Not a protocol specified timepoint
|
NA score on a scale
Not a protocol specified timepoint
|
-2.29 score on a scale
Interval -20.0 to 14.0
|
-6.25 score on a scale
Interval -18.0 to 2.0
|
|
Phase 1 and Phase 2: Change From Baseline in Motor Examination Part III Total Score in the "Off" Condition for the CERE-120 Group as Compared to the Sham Surgery Control Group at the Last Double-blind Assessment.
MONTH 24
|
-7.00 score on a scale
Interval -18.0 to 1.0
|
-4.00 score on a scale
Interval -16.0 to 10.0
|
-8.80 score on a scale
Interval -28.0 to 7.0
|
-5.46 score on a scale
Interval -30.0 to 13.0
|
Adverse Events
Phase 1: Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1: Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 2: CERE-120 Treatment Group
Serious events: 7 serious events
Other events: 24 other events
Deaths: 2 deaths
Phase 2: Sham Surgery Control Group
Serious events: 7 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1: Cohort 1
n=3 participants at risk
CERE-120 at 9.4 x 10\^11 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 1: Cohort 2
n=3 participants at risk
CERE-120 at 2.4 x 10\^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 2: CERE-120 Treatment Group
n=24 participants at risk
CERE-120 at 2.4 x 10\^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 2: Sham Surgery Control Group
n=27 participants at risk
Neurosurgical procedure that mimics the procedure for CERE-120 delivery. No injuections are performed during sham surgery.
|
|---|---|---|---|---|
|
Nervous system disorders
Left-sided acoustic neuroma
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • Number of events 1 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Cardiac disorders
Worsened Coronary Artery Disease
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • Number of events 1 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Cardiac disorders
Symptomatic Bradycardia
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • Number of events 1 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Cardiac disorders
Coronary Artery Stenosis, Symptomatic
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • Number of events 1 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
General disorders
Chest Pain with Activity
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • Number of events 1 • 5 years after surgery
|
|
General disorders
Generalized Weakness
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • Number of events 1 • 5 years after surgery
|
|
Infections and infestations
Post Surgical Infection of R Great Toe
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • Number of events 1 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Closed Head Injury Related to Fall
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • Number of events 1 • 5 years after surgery
|
|
Musculoskeletal and connective tissue disorders
Severe Right Knee Pain
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • Number of events 1 • 5 years after surgery
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • Number of events 1 • 5 years after surgery
|
|
Nervous system disorders
Right Frontal Hemorrhage
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • Number of events 1 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • Number of events 1 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Nervous system disorders
Acute Ischemic Stroke
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • Number of events 1 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Nervous system disorders
Increased Parkinson's Disease Symptoms
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • Number of events 1 • 5 years after surgery
|
|
Nervous system disorders
Subdural and Subarachnoid Hemorrhage Secondary to Syncope and Motor Vehicle Accident
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • Number of events 1 • 5 years after surgery
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • Number of events 1 • 5 years after surgery
|
|
Surgical and medical procedures
R Great Toe Joint Fusion with Bone Graft Surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • Number of events 1 • 5 years after surgery
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • Number of events 1 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
Other adverse events
| Measure |
Phase 1: Cohort 1
n=3 participants at risk
CERE-120 at 9.4 x 10\^11 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 1: Cohort 2
n=3 participants at risk
CERE-120 at 2.4 x 10\^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 2: CERE-120 Treatment Group
n=24 participants at risk
CERE-120 at 2.4 x 10\^12 vg, injected by a neurosurgeon directly in the substantia nigra and in the putamen
|
Phase 2: Sham Surgery Control Group
n=27 participants at risk
Neurosurgical procedure that mimics the procedure for CERE-120 delivery. No injuections are performed during sham surgery.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
8.3%
2/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Eye disorders
Cataract
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
7.4%
2/27 • 5 years after surgery
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
7.4%
2/27 • 5 years after surgery
|
|
Eye disorders
Eye Swelling
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
11.1%
3/27 • 5 years after surgery
|
|
Eye disorders
Eyelid Ptosis
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Eye disorders
Macular Hole
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Eye disorders
Pupils Unequal
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
16.7%
4/24 • 5 years after surgery
|
11.1%
3/27 • 5 years after surgery
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
16.7%
4/24 • 5 years after surgery
|
25.9%
7/27 • 5 years after surgery
|
|
Gastrointestinal disorders
Tongue Disorder
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
General disorders
Asthenia
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
8.3%
2/24 • 5 years after surgery
|
7.4%
2/27 • 5 years after surgery
|
|
General disorders
Chest Pain
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
General disorders
Fatigue
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
16.7%
4/24 • 5 years after surgery
|
11.1%
3/27 • 5 years after surgery
|
|
General disorders
Gait Disturbance
|
0.00%
0/3 • 5 years after surgery
|
33.3%
1/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
General disorders
Impaired Hearing
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
General disorders
Influenza Like Illness
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
General disorders
Oedema Peripheral
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
General disorders
Pain
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
14.8%
4/27 • 5 years after surgery
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Infections and infestations
Ear Infection
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Infections and infestations
Incision Site Infection
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Infections and infestations
Infected Sebaceous Cyst
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Infections and infestations
Infection
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Infections and infestations
Post Procedural Infection
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
8.3%
2/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Infections and infestations
Tooth Infection
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Infections and infestations
Tracheitis
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
8.3%
2/24 • 5 years after surgery
|
7.4%
2/27 • 5 years after surgery
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Anthropod Bite
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Confusion Postoperative
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Corneal Abrasion
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
18.5%
5/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
66.7%
2/3 • 5 years after surgery
|
66.7%
2/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
11.1%
3/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Injury
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Meniscus Lesion
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Mouth Injury
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
8.3%
2/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Post Procedural Odema
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
25.0%
6/24 • 5 years after surgery
|
44.4%
12/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Procedural Site Reaction
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Radiation Skin Injury
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Injury, poisoning and procedural complications
Stress Fracture
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Investigations
Blood Pressure Decreased
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Investigations
Cardiac Murmur
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Investigations
Electrocardiogram Abnormal
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Investigations
Gamma-glutamyltransferase Increased
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Investigations
Weight Decreased
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Metabolism and nutrition disorders
Fluid Retention
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/3 • 5 years after surgery
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • 5 years after surgery
|
66.7%
2/3 • 5 years after surgery
|
12.5%
3/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
11.1%
3/27 • 5 years after surgery
|
|
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis
|
0.00%
0/3 • 5 years after surgery
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Musculoskeletal and connective tissue disorders
Musclar Weakness
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
8.3%
2/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
8.3%
2/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
7.4%
2/27 • 5 years after surgery
|
|
Musculoskeletal and connective tissue disorders
Osteroarthritis
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
8.3%
2/24 • 5 years after surgery
|
11.1%
3/27 • 5 years after surgery
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurilemmoma
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
8.3%
2/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Nervous system disorders
Drooling
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Nervous system disorders
Dyskinesia
|
66.7%
2/3 • 5 years after surgery
|
66.7%
2/3 • 5 years after surgery
|
25.0%
6/24 • 5 years after surgery
|
18.5%
5/27 • 5 years after surgery
|
|
Nervous system disorders
Dystonia
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
8.3%
2/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • 5 years after surgery
|
33.3%
1/3 • 5 years after surgery
|
29.2%
7/24 • 5 years after surgery
|
40.7%
11/27 • 5 years after surgery
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
11.1%
3/27 • 5 years after surgery
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
12.5%
3/24 • 5 years after surgery
|
11.1%
3/27 • 5 years after surgery
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
12.5%
3/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
12.5%
3/24 • 5 years after surgery
|
22.2%
6/27 • 5 years after surgery
|
|
Nervous system disorders
Parosmia
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Nervous system disorders
Restless Leg Syndrome
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Nervous system disorders
Sensory Disturbance
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Nervous system disorders
Sleep Phase Rhythm Disturbance
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
8.3%
2/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Psychiatric disorders
Abnormal Dreams
|
33.3%
1/3 • 5 years after surgery
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
7.4%
2/27 • 5 years after surgery
|
|
Psychiatric disorders
Apathy
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Psychiatric disorders
Delusions, Mixed
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
12.5%
3/24 • 5 years after surgery
|
14.8%
4/27 • 5 years after surgery
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
12.5%
3/24 • 5 years after surgery
|
11.1%
3/27 • 5 years after surgery
|
|
Psychiatric disorders
Libido Increased
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Psychiatric disorders
Obsessive-compulsive Disorder
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Psychiatric disorders
Pathological Gambling
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Psychiatric disorders
Rapid Eye Movements Sleep Abnormal
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Psychiatric disorders
Social Avoidant Behavior
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • 5 years after surgery
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Renal and urinary disorders
Micturition Urgency
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
8.3%
2/24 • 5 years after surgery
|
7.4%
2/27 • 5 years after surgery
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Reproductive system and breast disorders
Breast Cyst
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Reproductive system and breast disorders
Uterine Cyst
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 5 years after surgery
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
7.4%
2/27 • 5 years after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Seasonal
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
7.4%
2/27 • 5 years after surgery
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Surgical and medical procedures
External Fixation of Fracture
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Surgical and medical procedures
Joint Surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Surgical and medical procedures
Tooth Extraction
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Surgical and medical procedures
Varicose Vein Operation
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
4.2%
1/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
8.3%
2/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Vascular disorders
Varicose Vein
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/3 • 5 years after surgery
|
33.3%
1/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
0.00%
0/27 • 5 years after surgery
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
7.4%
2/27 • 5 years after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/3 • 5 years after surgery
|
0.00%
0/24 • 5 years after surgery
|
3.7%
1/27 • 5 years after surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place