Trial Outcomes & Findings for Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels (NCT NCT00637156)
NCT ID: NCT00637156
Last Updated: 2018-05-01
Results Overview
Rate of overall success is reported as the percentage of participants who met all of the following criteria: 1. Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative; 2. Maintenance or improvement in neurological status; 3. No serious adverse event classified as implant associated or implant/surgical procedure associated; and 4. No additional surgical procedure classified as a "failure."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
397 participants
Primary outcome timeframe
24 Months
Results posted on
2018-05-01
Participant Flow
Participant milestones
| Measure |
PRESTIGE LP Device
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Overall Study
STARTED
|
209
|
188
|
|
Overall Study
COMPLETED
|
199
|
164
|
|
Overall Study
NOT COMPLETED
|
10
|
24
|
Reasons for withdrawal
| Measure |
PRESTIGE LP Device
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
7
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
10
|
16
|
Baseline Characteristics
Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels
Baseline characteristics by cohort
| Measure |
PRESTIGE LP Device
n=209 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=188 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
Total
n=397 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
47.3 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
47.2 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
195 participants
n=5 Participants
|
172 participants
n=7 Participants
|
367 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Height
|
67.2 inches
STANDARD_DEVIATION 3.9 • n=5 Participants
|
67.6 inches
STANDARD_DEVIATION 4.0 • n=7 Participants
|
67.4 inches
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Weight
|
182.1 lbs
STANDARD_DEVIATION 42.6 • n=5 Participants
|
186.3 lbs
STANDARD_DEVIATION 37.2 • n=7 Participants
|
184.0 lbs
STANDARD_DEVIATION 40.1 • n=5 Participants
|
|
BMI
|
28.2 kg/m^2
STANDARD_DEVIATION 5.6 • n=5 Participants
|
28.6 kg/m^2
STANDARD_DEVIATION 4.9 • n=7 Participants
|
28.4 kg/m^2
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Marital Status
Single
|
25 participants
n=5 Participants
|
29 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Marital Status
Married
|
146 participants
n=5 Participants
|
133 participants
n=7 Participants
|
279 participants
n=5 Participants
|
|
Marital Status
Divorced
|
32 participants
n=5 Participants
|
23 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Marital Status
Separated
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Marital Status
Widowed
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Education Level
<High school
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Education Level
High school
|
63 participants
n=5 Participants
|
64 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
Education Level
>High school
|
125 participants
n=5 Participants
|
104 participants
n=7 Participants
|
229 participants
n=5 Participants
|
|
Worker's Compensation
Yes
|
26 participants
n=5 Participants
|
19 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Worker's Compensation
No
|
183 participants
n=5 Participants
|
169 participants
n=7 Participants
|
352 participants
n=5 Participants
|
|
Unresolved Spinal litigation
Yes
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Unresolved Spinal litigation
No
|
209 participants
n=5 Participants
|
187 participants
n=7 Participants
|
396 participants
n=5 Participants
|
|
Alcohol Used
Yes
|
116 participants
n=5 Participants
|
88 participants
n=7 Participants
|
204 participants
n=5 Participants
|
|
Alcohol Used
No
|
93 participants
n=5 Participants
|
100 participants
n=7 Participants
|
193 participants
n=5 Participants
|
|
Preoperative Work Status
Yes
|
146 participants
n=5 Participants
|
113 participants
n=7 Participants
|
259 participants
n=5 Participants
|
|
Preoperative Work Status
No
|
63 participants
n=5 Participants
|
75 participants
n=7 Participants
|
138 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 MonthsPopulation: The primary analysis dataset for this study included all subjects who received study devices and completed the initial surgical procedures. The analysis was based on the observed data and missing data due to lost-to-follow-ups were imputed. For the primary endpoint, the analysis consists of 199 investigational subjects and 160 control subjects.
Rate of overall success is reported as the percentage of participants who met all of the following criteria: 1. Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative; 2. Maintenance or improvement in neurological status; 3. No serious adverse event classified as implant associated or implant/surgical procedure associated; and 4. No additional surgical procedure classified as a "failure."
Outcome measures
| Measure |
PRESTIGE LP Device
n=199 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=160 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Rate of Overall Success
|
81.4 percentage of participants
|
69.4 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.
Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met the following criterion: Pre-treatment Score - Post-treatment Score ≥ 15.
Outcome measures
| Measure |
PRESTIGE LP Device
n=199 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=159 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Success Rate of Neck Disability Index
|
87.9 percentage of participants
|
79.2 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neurological success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.
Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must either remain the same or improve from the time of the preoperative evaluation to the time period evaluated.
Outcome measures
| Measure |
PRESTIGE LP Device
n=199 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=159 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Success Rate of Neurological Status
|
91.5 percentage of participants
|
86.2 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.
Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met the following criterion: Preoperative Score - Postoperative Score \> 0.
Outcome measures
| Measure |
PRESTIGE LP Device
n=199 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=159 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Neck Pain Success Rate
|
98.0 percentage of participants
|
95.6 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.
Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met the following criterion: Preoperative Score - Postoperative Score \> 0.
Outcome measures
| Measure |
PRESTIGE LP Device
n=199 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=159 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Arm Pain Success Rate
|
88.9 percentage of participants
|
89.9 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 PCS success status at 24 months, which leads to 197 subjects in the investigational group and 156 subjects in the control group.
Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score \>= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.
Outcome measures
| Measure |
PRESTIGE LP Device
n=197 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=156 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Success Rate of SF-36 PCS
|
90.4 percentage of participants
|
87.8 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 MCS success status at 24 months, which leads to 197 subjects in the investigational group and 156 subjects in the control group.
Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score \>= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.
Outcome measures
| Measure |
PRESTIGE LP Device
n=197 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=156 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Success Rate of SF-36 MCS
|
69.0 percentage of participants
|
72.4 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable disc height success (FSU success) status at 24 months, which leads to 170 subjects in the investigational group and 138 subjects in the control group.
Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height \>= -2mm
Outcome measures
| Measure |
PRESTIGE LP Device
n=170 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=138 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Rate of Disc Height Success
|
93.5 percentage of participants
|
95.7 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable gait success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.
Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score \>= 0. The gait success rate is reported as the percentage of participants who had gait success.
Outcome measures
| Measure |
PRESTIGE LP Device
n=199 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=159 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Gait Success Rate
|
100.0 percentage of participants
|
98.7 percentage of participants
|
SECONDARY outcome
Timeframe: Time of operation, an average of 1.7-2.1hrsOperative time was recorded from skin incision to wound closure.
Outcome measures
| Measure |
PRESTIGE LP Device
n=209 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=188 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Operative Time
|
2.1 hrs
Standard Deviation 0.8
|
1.7 hrs
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: During the time of operation, an average of 1.7-2.1 hrsOutcome measures
| Measure |
PRESTIGE LP Device
n=208 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=188 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Blood Loss
|
67.2 ml
Standard Deviation 64.1
|
55.7 ml
Standard Deviation 46.3
|
SECONDARY outcome
Timeframe: From admission to discharge, an average of 1.0-1.5 dayOutcome measures
| Measure |
PRESTIGE LP Device
n=209 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=188 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Hospital Stay
|
1.2 days
Standard Deviation 0.5
|
1.3 days
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 24 monthsSecondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of subjects who had secondary surgeries at index level.
Outcome measures
| Measure |
PRESTIGE LP Device
n=209 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=188 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Rate of Secondary Surgery at Index Level
|
2.4 percentage of participants
|
8.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 24 months post-operationThe self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.
Outcome measures
| Measure |
PRESTIGE LP Device
n=209 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=188 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Change of Neck Disability Index Score From Baseline
NDI at baseline (n=209, 188)
|
52.1 units on a scale
Standard Deviation 13.4
|
53.2 units on a scale
Standard Deviation 14.8
|
|
Change of Neck Disability Index Score From Baseline
NDI at 24 months (n=199, 159)
|
15.0 units on a scale
Standard Deviation 16.6
|
20.0 units on a scale
Standard Deviation 20.5
|
|
Change of Neck Disability Index Score From Baseline
NDI change (n=199, 159)
|
-37.0 units on a scale
Standard Deviation 17.8
|
-32.5 units on a scale
Standard Deviation 19.1
|
SECONDARY outcome
Timeframe: Baseline and 24 months post-operationNumerical rating scales were used to evaluate neck pain intensity and frequency. Subjects rated their neck pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their neck pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total neck pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline.
Outcome measures
| Measure |
PRESTIGE LP Device
n=209 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=188 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Change of Neck Pain Score From Baseline
Neck pain at baseline (n=209, 188)
|
16.2 units on a scale
Standard Deviation 2.9
|
16.3 units on a scale
Standard Deviation 2.6
|
|
Change of Neck Pain Score From Baseline
Neck pain at 24 months (n=199, 159)
|
4.3 units on a scale
Standard Deviation 4.9
|
5.9 units on a scale
Standard Deviation 5.5
|
|
Change of Neck Pain Score From Baseline
Neck pain change (n=199, 159)
|
-11.8 units on a scale
Standard Deviation 5.2
|
-10.3 units on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Baseline and 24 months post-operationNumerical rating scales were also used to evaluate arm pain intensity and frequency. Subjects rated their arm pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their arm pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total arm pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline.
Outcome measures
| Measure |
PRESTIGE LP Device
n=209 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=188 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Change of Arm Pain Score From Baseline
Arm pain at baseline (n=209, 188)
|
13.8 units on a scale
Standard Deviation 5.6
|
14.4 units on a scale
Standard Deviation 4.3
|
|
Change of Arm Pain Score From Baseline
Arm pain at 24 months (n=199, 159)
|
3.0 units on a scale
Standard Deviation 4.8
|
4.0 units on a scale
Standard Deviation 5.6
|
|
Change of Arm Pain Score From Baseline
Arm pain change (n=199, 159)
|
-10.9 units on a scale
Standard Deviation 6.7
|
-10.2 units on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Baseline and 24 months post-operationThe Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.
Outcome measures
| Measure |
PRESTIGE LP Device
n=209 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=188 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Change of General Health Status -- SF-36 PCS From Baseline
SF-36 PCS at baseline (n=209, 188)
|
31.8 units on a scale
Standard Deviation 7.8
|
30.8 units on a scale
Standard Deviation 7.4
|
|
Change of General Health Status -- SF-36 PCS From Baseline
SF-36 PCS at 24 months (n=197, 156)
|
47.3 units on a scale
Standard Deviation 10.7
|
45.4 units on a scale
Standard Deviation 11.5
|
|
Change of General Health Status -- SF-36 PCS From Baseline
SF-36 PCS change (n=197, 156)
|
15.3 units on a scale
Standard Deviation 11.5
|
13.8 units on a scale
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Baseline and 24 months post-operationThe Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.
Outcome measures
| Measure |
PRESTIGE LP Device
n=209 Participants
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=188 Participants
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Change of General Health Status -- SF-36 MCS From Baseline
SF-36 MCS at baseline (n=209, 188)
|
43.9 units on a scale
Standard Deviation 11.8
|
43.8 units on a scale
Standard Deviation 12.2
|
|
Change of General Health Status -- SF-36 MCS From Baseline
SF-36 MCS at 24 months (n=197, 156)
|
52.1 units on a scale
Standard Deviation 10.8
|
50.9 units on a scale
Standard Deviation 10.5
|
|
Change of General Health Status -- SF-36 MCS From Baseline
SF-36 MCS change (n=197, 156)
|
8.1 units on a scale
Standard Deviation 14.5
|
6.9 units on a scale
Standard Deviation 12.6
|
Adverse Events
PRESTIGE LP Device
Serious events: 72 serious events
Other events: 191 other events
Deaths: 0 deaths
ATLANTIS Cervical Plate System
Serious events: 90 serious events
Other events: 171 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PRESTIGE LP Device
n=209 participants at risk
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=188 participants at risk
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Renal and urinary disorders
Urinary retention
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Reproductive system and breast disorders
Uterine enlargement
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum perforation
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/209 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural fibrosis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Cardiac disorders
Aortic valve incompetence
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Cardiac disorders
Mitral valve incompetence
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Cardiac disorders
Palpitations
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Congenital, familial and genetic disorders
Arnold-Chiari malformation
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Congenital, familial and genetic disorders
Chronic granulomatous disease
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Congenital, familial and genetic disorders
Myocardial bridging
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Congenital, familial and genetic disorders
Spine malformation
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Endocrine disorders
Thyrotoxic crisis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Eye disorders
Blindness
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Eye disorders
Cataract subcapsular
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Eye disorders
Conjunctivitis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
4/209 • Number of events 5 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Constipation
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Gastritis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Mesenteric occlusion
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Nausea
|
1.4%
3/209 • Number of events 4 • up to 24 months
|
3.7%
7/188 • Number of events 7 • up to 24 months
|
|
Gastrointestinal disorders
Oesophageal disorder
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Tooth loss
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
2.1%
4/188 • Number of events 4 • up to 24 months
|
|
General disorders
Abasia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
General disorders
Adverse drug reaction
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
General disorders
Chest discomfort
|
0.48%
1/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
General disorders
Chest pain
|
2.9%
6/209 • Number of events 6 • up to 24 months
|
2.1%
4/188 • Number of events 4 • up to 24 months
|
|
General disorders
Chills
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
General disorders
Cyst
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
General disorders
Death
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
General disorders
Device breakage
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
General disorders
Device connection issue
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
General disorders
Device dislocation
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
2.1%
4/188 • Number of events 4 • up to 24 months
|
|
General disorders
Facial pain
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
General disorders
Fatigue
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
General disorders
Feeling abnormal
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
General disorders
Gait disturbance
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
General disorders
Hernia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
General disorders
Pain
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
2.1%
4/188 • Number of events 4 • up to 24 months
|
|
General disorders
Pyrexia
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
General disorders
Sensation of pressure
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
General disorders
Spinal pain
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Infections and infestations
Cellulitis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Enterobacter infection
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Infections and infestations
Gastroenteritis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Helicobacter infection
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Infections and infestations
Lyme disease
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Pneumonia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Sinusitis
|
0.96%
2/209 • Number of events 3 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Infections and infestations
Skin graft infection
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Urinary tract infection
|
0.96%
2/209 • Number of events 3 • up to 24 months
|
2.1%
4/188 • Number of events 4 • up to 24 months
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.6%
3/188 • Number of events 4 • up to 24 months
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Cranial nerve injury
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Dural tear
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.48%
1/209 • Number of events 3 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
7/209 • Number of events 8 • up to 24 months
|
5.3%
10/188 • Number of events 11 • up to 24 months
|
|
Injury, poisoning and procedural complications
Flatback syndrome
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Injury
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Injury, poisoning and procedural complications
Kyphosis postoperative
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
2.1%
4/188 • Number of events 5 • up to 24 months
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Open wound
|
0.48%
1/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Overdose
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.6%
3/188 • Number of events 5 • up to 24 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.9%
4/209 • Number of events 4 • up to 24 months
|
4.8%
9/188 • Number of events 9 • up to 24 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Sports injury
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Injury, poisoning and procedural complications
Traumatic lung injury
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Arthroscopy
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Blood glucose fluctuation
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Blood glucose increased
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Blood pressure increased
|
0.48%
1/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Bone scan abnormal
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Computerised tomogram abnormal
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Drug screen positive
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Electrocardiogram abnormal
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Foetal heart rate abnormal
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Foetal monitoring
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Grip strength decreased
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Haematocrit decreased
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Liver function test abnormal
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Neurological examination abnormal
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Nuclear magnetic resonance imaging abnormal
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Spinal X-ray abnormal
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Weight decreased
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Weight increased
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
X-ray of pelvis and hip abnormal
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Metabolism and nutrition disorders
Gout
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
2.1%
4/188 • Number of events 4 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
5/209 • Number of events 5 • up to 24 months
|
2.7%
5/188 • Number of events 5 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
2.9%
6/209 • Number of events 7 • up to 24 months
|
5.9%
11/188 • Number of events 12 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
1.9%
4/209 • Number of events 4 • up to 24 months
|
5.3%
10/188 • Number of events 10 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
3.3%
7/209 • Number of events 7 • up to 24 months
|
5.3%
10/188 • Number of events 10 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/209 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
5.3%
11/209 • Number of events 12 • up to 24 months
|
9.6%
18/188 • Number of events 20 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc space narrowing
|
1.9%
4/209 • Number of events 4 • up to 24 months
|
2.1%
4/188 • Number of events 4 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
0.00%
0/209 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Ligament disorder
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
3.7%
7/188 • Number of events 7 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/209 • up to 24 months
|
1.6%
3/188 • Number of events 4 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.4%
5/209 • Number of events 5 • up to 24 months
|
4.8%
9/188 • Number of events 11 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.9%
4/209 • Number of events 4 • up to 24 months
|
5.3%
10/188 • Number of events 10 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.9%
4/209 • Number of events 4 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
5.9%
11/188 • Number of events 12 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/209 • up to 24 months
|
5.3%
10/188 • Number of events 10 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.9%
4/209 • Number of events 5 • up to 24 months
|
1.6%
3/188 • Number of events 4 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.9%
6/209 • Number of events 6 • up to 24 months
|
2.1%
4/188 • Number of events 6 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
1.9%
4/209 • Number of events 4 • up to 24 months
|
2.1%
4/188 • Number of events 5 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
2.4%
5/209 • Number of events 6 • up to 24 months
|
4.3%
8/188 • Number of events 10 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Carotid artery disease
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Carpal tunnel syndrome
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Nervous system disorders
Cerebral atrophy
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Cerebral hypoperfusion
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Cervical cord compression
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Cervical myelopathy
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Cervicobrachial syndrome
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Convulsion
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Dizziness
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Headache
|
2.4%
5/209 • Number of events 6 • up to 24 months
|
2.7%
5/188 • Number of events 5 • up to 24 months
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Hypoaesthesia
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Intracranial hypotension
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Nervous system disorders
Loss of consciousness
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Nervous system disorders
Migraine
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Nervous system disorders
Neuralgia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Radicular pain
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Nervous system disorders
Radiculitis brachial
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Radiculopathy
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Sensory loss
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Spinal claudication
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Spinal cord compression
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Syncope
|
0.48%
1/209 • Number of events 2 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Nervous system disorders
Tongue paralysis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Psychiatric disorders
Aggression
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Psychiatric disorders
Anxiety
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Psychiatric disorders
Confusional state
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Psychiatric disorders
Depression
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Psychiatric disorders
Insomnia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Psychiatric disorders
Panic attack
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Renal and urinary disorders
Haematuria
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Social circumstances
Tobacco user
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Surgical and medical procedures
Bunion operation
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Surgical and medical procedures
Gastric banding
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Surgical and medical procedures
Peripheral nerve decompression
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Surgical and medical procedures
Prolapse repair
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Surgical and medical procedures
Rotator cuff repair
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Surgical and medical procedures
Skin graft
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Surgical and medical procedures
Spinal decompression
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.00%
0/209 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Surgical and medical procedures
Vascular stent insertion
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Vascular disorders
Haematoma
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Vascular disorders
Intermittent claudication
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
Other adverse events
| Measure |
PRESTIGE LP Device
n=209 participants at risk
PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
|
ATLANTIS Cervical Plate System
n=188 participants at risk
Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
2.1%
4/188 • Number of events 4 • up to 24 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 2 • up to 24 months
|
|
Cardiac disorders
Arrhythmia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Cardiac disorders
Bradycardia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Cardiac disorders
Bundle branch block left
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Cardiac disorders
Palpitations
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Cardiac disorders
Tachycardia
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Congenital, familial and genetic disorders
Congenital choroid plexus cyst
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Congenital, familial and genetic disorders
Spine malformation
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Endocrine disorders
Adrenal cyst
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Eye disorders
Blepharospasm
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Eye disorders
Cataract
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Eye disorders
Conjunctival discolouration
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Eye disorders
Conjunctivitis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Eye disorders
Eye swelling
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Eye disorders
Macular degeneration
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Eye disorders
Papilloedema
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Eye disorders
Photophobia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Eye disorders
Scintillating scotoma
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Acquired oesophageal web
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Colitis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Colonic polyp
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Gastrointestinal disorders
Constipation
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
4/209 • Number of events 4 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
7/209 • Number of events 7 • up to 24 months
|
9.0%
17/188 • Number of events 17 • up to 24 months
|
|
Gastrointestinal disorders
Eructation
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Gastric polyps
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.9%
4/209 • Number of events 4 • up to 24 months
|
3.2%
6/188 • Number of events 6 • up to 24 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Loose tooth
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Nausea
|
4.3%
9/209 • Number of events 10 • up to 24 months
|
4.3%
8/188 • Number of events 9 • up to 24 months
|
|
Gastrointestinal disorders
Odynophagia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Gastrointestinal disorders
Oesophagitis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Proctalgia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Gastrointestinal disorders
Salivary gland mass
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Tooth erosion
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
6/209 • Number of events 6 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
General disorders
Adverse drug reaction
|
3.3%
7/209 • Number of events 7 • up to 24 months
|
2.7%
5/188 • Number of events 5 • up to 24 months
|
|
General disorders
Asthenia
|
0.00%
0/209 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
General disorders
Chest discomfort
|
2.9%
6/209 • Number of events 6 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
General disorders
Chest pain
|
2.4%
5/209 • Number of events 5 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
General disorders
Chills
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
General disorders
Complication of device insertion
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
General disorders
Cyst
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
2.1%
4/188 • Number of events 4 • up to 24 months
|
|
General disorders
Device breakage
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
General disorders
Device connection issue
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
General disorders
Device deployment issue
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
General disorders
Device dislocation
|
2.4%
5/209 • Number of events 6 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
General disorders
Face oedema
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
General disorders
Fatigue
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
General disorders
Feeling cold
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
General disorders
Gait disturbance
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
General disorders
Hernia
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
General disorders
Impaired healing
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
General disorders
Local swelling
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
General disorders
Localised oedema
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
General disorders
Malaise
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
General disorders
Medical device complication
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
General disorders
Medical device discomfort
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
General disorders
Oedema
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
General disorders
Oedema peripheral
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
General disorders
Pain
|
5.7%
12/209 • Number of events 12 • up to 24 months
|
3.7%
7/188 • Number of events 7 • up to 24 months
|
|
General disorders
Polyp
|
0.00%
0/209 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
General disorders
Pyrexia
|
0.00%
0/209 • up to 24 months
|
3.7%
7/188 • Number of events 7 • up to 24 months
|
|
General disorders
Secretion discharge
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
General disorders
Sensation of foreign body
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
General disorders
Spinal pain
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
General disorders
Swelling
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
General disorders
Tenderness
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Immune system disorders
Seasonal allergy
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Infections and infestations
Abscess limb
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Infections and infestations
Acute sinusitis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Infections and infestations
Bacterial infection
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Bronchitis
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Infections and infestations
Cellulitis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Infections and infestations
Gastrointestinal infection
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Infections and infestations
Helicobacter infection
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Influenza
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Kidney infection
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Infections and infestations
Klebsiella infection
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Infections and infestations
Nasopharyngitis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Infections and infestations
Onychomycosis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Otitis externa
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Pneumonia
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Sinusitis
|
2.4%
5/209 • Number of events 5 • up to 24 months
|
2.1%
4/188 • Number of events 4 • up to 24 months
|
|
Infections and infestations
Stitch abscess
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Infections and infestations
Streptococcal infection
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.96%
2/209 • Number of events 3 • up to 24 months
|
2.1%
4/188 • Number of events 4 • up to 24 months
|
|
Infections and infestations
Urinary tract infection
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
2.1%
4/188 • Number of events 4 • up to 24 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Accident
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Injury, poisoning and procedural complications
Accident at home
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Concussion
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.48%
1/209 • Number of events 2 • up to 24 months
|
0.53%
1/188 • Number of events 2 • up to 24 months
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
1.9%
4/209 • Number of events 4 • up to 24 months
|
2.7%
5/188 • Number of events 5 • up to 24 months
|
|
Injury, poisoning and procedural complications
Epidural fibrosis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
13/209 • Number of events 15 • up to 24 months
|
8.5%
16/188 • Number of events 24 • up to 24 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
2.7%
5/188 • Number of events 5 • up to 24 months
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Inadequate osteointegration
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Incision site hypoaesthesia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Incision site oedema
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Injury, poisoning and procedural complications
Injury
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Injury, poisoning and procedural complications
Joint injury
|
3.3%
7/209 • Number of events 7 • up to 24 months
|
3.2%
6/188 • Number of events 6 • up to 24 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.9%
4/209 • Number of events 4 • up to 24 months
|
2.1%
4/188 • Number of events 4 • up to 24 months
|
|
Injury, poisoning and procedural complications
Neck injury
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Nerve root injury cervical
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Nerve root injury lumbar
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Nerve root injury sacral
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Periorbital haemorrhage
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Repetitive strain injury
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
6.2%
13/209 • Number of events 13 • up to 24 months
|
4.3%
8/188 • Number of events 9 • up to 24 months
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Sports injury
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Ulnar nerve injury
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/209 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Investigations
Angiogram cerebral abnormal
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Investigations
Bacterial test positive
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Biopsy mucosa normal
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Biopsy oesophagus normal
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Blood cholesterol increased
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Investigations
Blood cortisol decreased
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Blood creatine phosphokinase increased
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Blood glucose increased
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Investigations
Blood pressure increased
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Bone scan abnormal
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Computerised tomogram abnormal
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
False positive investigation result
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Glomerular filtration rate decreased
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Grip strength decreased
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Heart rate increased
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
High density lipoprotein decreased
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Lasegue's test positive
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Lipids increased
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Mean cell haemoglobin
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Neurological examination
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Neurological examination abnormal
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Investigations
Nuclear magnetic resonance imaging abnormal
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Orthopedic examination abnormal
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Scan abnormal
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Scan bone marrow abnormal
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Sensory level abnormal
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
Spinal X-ray abnormal
|
0.00%
0/209 • up to 24 months
|
2.7%
5/188 • Number of events 5 • up to 24 months
|
|
Investigations
Staphylococcus test positive
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Stress echocardiogram abnormal
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Urine output decreased
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Investigations
Weight decreased
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Investigations
Weight increased
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
White blood cell count increased
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
X-ray abnormal
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Investigations
X-ray limb abnormal
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/209 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Metabolism and nutrition disorders
Vitamin C deficiency
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.6%
18/209 • Number of events 21 • up to 24 months
|
9.6%
18/188 • Number of events 20 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.3%
34/209 • Number of events 37 • up to 24 months
|
18.6%
35/188 • Number of events 39 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Bone erosion
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Bursa disorder
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.9%
4/209 • Number of events 4 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Cervical spine flattening
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
8.1%
17/209 • Number of events 19 • up to 24 months
|
5.9%
11/188 • Number of events 13 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
4.8%
10/209 • Number of events 11 • up to 24 months
|
5.3%
10/188 • Number of events 10 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/209 • up to 24 months
|
2.7%
5/188 • Number of events 5 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
6.7%
14/209 • Number of events 14 • up to 24 months
|
6.4%
12/188 • Number of events 12 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 3 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
5.7%
12/209 • Number of events 14 • up to 24 months
|
10.1%
19/188 • Number of events 24 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc space narrowing
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Jaw disorder
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
9.1%
19/209 • Number of events 23 • up to 24 months
|
2.7%
5/188 • Number of events 5 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint lock
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
2.9%
6/209 • Number of events 6 • up to 24 months
|
4.8%
9/188 • Number of events 9 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
2.4%
5/209 • Number of events 5 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
1.1%
2/188 • Number of events 3 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.0%
23/209 • Number of events 25 • up to 24 months
|
6.4%
12/188 • Number of events 16 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
4.3%
9/209 • Number of events 10 • up to 24 months
|
3.2%
6/188 • Number of events 7 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.7%
14/209 • Number of events 15 • up to 24 months
|
4.3%
8/188 • Number of events 10 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
3.8%
8/209 • Number of events 9 • up to 24 months
|
4.3%
8/188 • Number of events 11 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
24.4%
51/209 • Number of events 59 • up to 24 months
|
20.7%
39/188 • Number of events 46 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
7.7%
16/209 • Number of events 18 • up to 24 months
|
7.4%
14/188 • Number of events 14 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
13/209 • Number of events 14 • up to 24 months
|
3.2%
6/188 • Number of events 6 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
30.6%
64/209 • Number of events 82 • up to 24 months
|
31.9%
60/188 • Number of events 77 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.9%
6/209 • Number of events 8 • up to 24 months
|
6.4%
12/188 • Number of events 17 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
19.6%
41/209 • Number of events 51 • up to 24 months
|
26.6%
50/188 • Number of events 58 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/209 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pelvic deformity
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/209 • up to 24 months
|
4.3%
8/188 • Number of events 8 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
3.8%
8/209 • Number of events 8 • up to 24 months
|
3.2%
6/188 • Number of events 7 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
1.9%
4/209 • Number of events 4 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Spinal deformity
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Spinal fusion acquired
|
2.9%
6/209 • Number of events 6 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
4.3%
9/209 • Number of events 9 • up to 24 months
|
8.0%
15/188 • Number of events 16 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
1.9%
4/209 • Number of events 4 • up to 24 months
|
2.7%
5/188 • Number of events 7 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Spondylolysis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Syndesmophyte
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/209 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
3.2%
6/188 • Number of events 7 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
4.8%
10/209 • Number of events 13 • up to 24 months
|
6.4%
12/188 • Number of events 12 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign nipple neoplasm
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurofibroma
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour recurrent
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal haemangioma
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.48%
1/209 • Number of events 2 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Nervous system disorders
Amnesia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Aphonia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Areflexia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Ataxia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Aura
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Benign intracranial hypertension
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Brachial plexopathy
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Burning sensation
|
2.9%
6/209 • Number of events 6 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Carpal tunnel syndrome
|
5.3%
11/209 • Number of events 11 • up to 24 months
|
5.3%
10/188 • Number of events 11 • up to 24 months
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 2 • up to 24 months
|
|
Nervous system disorders
Cerebral small vessel ischaemic disease
|
0.48%
1/209 • Number of events 2 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Cervical cord compression
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Cervicobrachial syndrome
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
1.6%
3/188 • Number of events 5 • up to 24 months
|
|
Nervous system disorders
Cervicogenic headache
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Convulsion
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Nervous system disorders
Demyelination
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Diabetic neuropathy
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Dizziness
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
1.1%
2/188 • Number of events 3 • up to 24 months
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Dysaesthesia
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
2.1%
4/188 • Number of events 5 • up to 24 months
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Extensor plantar response
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Gait spastic
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Head titubation
|
0.00%
0/209 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Headache
|
14.8%
31/209 • Number of events 33 • up to 24 months
|
18.6%
35/188 • Number of events 44 • up to 24 months
|
|
Nervous system disorders
Hemiparesis
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Hyperreflexia
|
0.00%
0/209 • up to 24 months
|
2.7%
5/188 • Number of events 5 • up to 24 months
|
|
Nervous system disorders
Hypoaesthesia
|
20.1%
42/209 • Number of events 55 • up to 24 months
|
20.2%
38/188 • Number of events 47 • up to 24 months
|
|
Nervous system disorders
Hyporeflexia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
2.1%
4/188 • Number of events 5 • up to 24 months
|
|
Nervous system disorders
Loss of consciousness
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/209 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Nervous system disorders
Migraine
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
3.2%
6/188 • Number of events 6 • up to 24 months
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Nerve compression
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Nerve root compression
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Nerve root lesion
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Neuritis
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Nervous system disorders
Neurological decompensation
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Nervous system disorders
Occipital neuralgia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Paraesthesia
|
15.8%
33/209 • Number of events 42 • up to 24 months
|
8.5%
16/188 • Number of events 17 • up to 24 months
|
|
Nervous system disorders
Periodic limb movement disorder
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Radial nerve compression
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Radicular pain
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Radicular syndrome
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Radiculitis lumbosacral
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Radiculopathy
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Nervous system disorders
Sciatica
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Nervous system disorders
Sensory disturbance
|
1.4%
3/209 • Number of events 4 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Nervous system disorders
Sensory loss
|
2.9%
6/209 • Number of events 6 • up to 24 months
|
3.2%
6/188 • Number of events 6 • up to 24 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Syncope
|
1.4%
3/209 • Number of events 5 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Syringomyelia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Tinel's sign
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Tremor
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Vocal cord paralysis
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Nervous system disorders
Vocal cord paresis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Psychiatric disorders
Anxiety
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Psychiatric disorders
Depression
|
1.9%
4/209 • Number of events 4 • up to 24 months
|
2.1%
4/188 • Number of events 4 • up to 24 months
|
|
Psychiatric disorders
Disorientation
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Psychiatric disorders
Drug dependence
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Psychiatric disorders
Hallucination
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Psychiatric disorders
Insomnia
|
2.9%
6/209 • Number of events 7 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Psychiatric disorders
Mental status changes
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Psychiatric disorders
Panic attack
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Psychiatric disorders
Psychosomatic disease
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Psychiatric disorders
Somatoform disorder
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Psychiatric disorders
Stress
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Psychiatric disorders
Tension
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Renal and urinary disorders
Bladder dysfunction
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Renal and urinary disorders
Calculus bladder
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Renal and urinary disorders
Cystitis interstitial
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Renal and urinary disorders
Dysuria
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Renal and urinary disorders
Haematuria
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Renal and urinary disorders
Micturition urgency
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Renal and urinary disorders
Renal cyst
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Renal and urinary disorders
Renal disorder
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Renal and urinary disorders
Urinary retention
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Breast cyst
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Reproductive system and breast disorders
Breast discharge
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Breast fibrosis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Reproductive system and breast disorders
Endometriosis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Testicular pain
|
0.48%
1/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Apnoeic attack
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
1.6%
3/188 • Number of events 4 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
9/209 • Number of events 10 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
2.7%
5/188 • Number of events 5 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
4/209 • Number of events 4 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.9%
4/209 • Number of events 4 • up to 24 months
|
2.7%
5/188 • Number of events 6 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mass
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/209 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
2.7%
5/188 • Number of events 6 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.96%
2/209 • Number of events 2 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.4%
3/209 • Number of events 3 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/209 • up to 24 months
|
1.6%
3/188 • Number of events 3 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 3 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Lentigo
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
5/209 • Number of events 7 • up to 24 months
|
2.7%
5/188 • Number of events 6 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Sebaceous gland disorder
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Surgical and medical procedures
Canalith repositioning procedure
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Surgical and medical procedures
Colon polypectomy
|
0.00%
0/209 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Surgical and medical procedures
Sinus operation
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Surgical and medical procedures
Urostomy
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Vascular disorders
Haematoma
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Vascular disorders
Hot flush
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 2 • up to 24 months
|
|
Vascular disorders
Hypertension
|
3.3%
7/209 • Number of events 7 • up to 24 months
|
2.7%
5/188 • Number of events 5 • up to 24 months
|
|
Vascular disorders
Lymphoedema
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Vascular disorders
Varicose vein
|
0.00%
0/209 • up to 24 months
|
1.1%
2/188 • Number of events 2 • up to 24 months
|
|
Vascular disorders
Vasodilatation
|
0.00%
0/209 • up to 24 months
|
0.53%
1/188 • Number of events 1 • up to 24 months
|
|
Vascular disorders
Venous insufficiency
|
0.48%
1/209 • Number of events 1 • up to 24 months
|
0.00%
0/188 • up to 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60