Trial Outcomes & Findings for INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervical Plate Pivotal Clinical Trial (NCT NCT00485173)
NCT ID: NCT00485173
Last Updated: 2013-03-19
Results Overview
Rate of overall success is reported as the percentage of participants who met all of the following criteria: 1. fusion at the treated level; 2. pain/disability (Neck Disability Index) success; 3. neurological status success; 4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated;" 5. no additional surgical procedure classified as a "failure."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
224 participants
Primary outcome timeframe
24 months post-operation
Results posted on
2013-03-19
Participant Flow
Five subjects in investigational group and 4 subjects in control group died within 24 months postoperatively. Among them, however, one investigational subject who died at 20 months and one control subject who died at 23 months reported some data that were included as the 24-month evaluation. Thus, they were counted as evaluated at 24 months.
Participant milestones
| Measure |
INFUSE® Bone Graft
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Overall Study
STARTED
|
224
|
486
|
|
Overall Study
COMPLETED
|
188
|
422
|
|
Overall Study
NOT COMPLETED
|
36
|
64
|
Reasons for withdrawal
| Measure |
INFUSE® Bone Graft
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Overall Study
Death
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
32
|
61
|
Baseline Characteristics
INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervical Plate Pivotal Clinical Trial
Baseline characteristics by cohort
| Measure |
INFUSE® Bone Graft
n=224 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=486 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
Total
n=710 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
46.8 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
45.0 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
251 Participants
n=7 Participants
|
369 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
341 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
198 participants
n=5 Participants
|
447 participants
n=7 Participants
|
645 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=5 Participants
|
13 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Height
|
67.5 in.
STANDARD_DEVIATION 4.2 • n=5 Participants
|
67.5 in.
STANDARD_DEVIATION 4.0 • n=7 Participants
|
67.5 in.
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Weight
|
188.8 lbs.
STANDARD_DEVIATION 43.6 • n=5 Participants
|
182.5 lbs.
STANDARD_DEVIATION 40.4 • n=7 Participants
|
184.5 lbs.
STANDARD_DEVIATION 41.5 • n=5 Participants
|
|
Marital Status
Single
|
30 participants
n=5 Participants
|
61 participants
n=7 Participants
|
91 participants
n=5 Participants
|
|
Marital Status
Married
|
163 participants
n=5 Participants
|
373 participants
n=7 Participants
|
536 participants
n=5 Participants
|
|
Marital Status
Divorced
|
21 participants
n=5 Participants
|
44 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Marital Status
Separated
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Marital Status
Widowed
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Education Level
< high School
|
10 participants
n=5 Participants
|
29 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Education Level
High School
|
80 participants
n=5 Participants
|
142 participants
n=7 Participants
|
222 participants
n=5 Participants
|
|
Education Level
> high School
|
134 participants
n=5 Participants
|
314 participants
n=7 Participants
|
448 participants
n=5 Participants
|
|
Worker's Compensation
Yes
|
5 participants
n=5 Participants
|
46 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Worker's Compensation
No
|
219 participants
n=5 Participants
|
440 participants
n=7 Participants
|
659 participants
n=5 Participants
|
|
Unresolved Spinal Litigation
Yes
|
28 participants
n=5 Participants
|
38 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Unresolved Spinal Litigation
No
|
196 participants
n=5 Participants
|
448 participants
n=7 Participants
|
644 participants
n=5 Participants
|
|
Tobacco Used
Yes
|
66 participants
n=5 Participants
|
145 participants
n=7 Participants
|
211 participants
n=5 Participants
|
|
Tobacco Used
No
|
157 participants
n=5 Participants
|
341 participants
n=7 Participants
|
498 participants
n=5 Participants
|
|
Alcohol Used
Yes
|
111 participants
n=5 Participants
|
150 participants
n=7 Participants
|
261 participants
n=5 Participants
|
|
Alcohol Used
No
|
113 participants
n=5 Participants
|
336 participants
n=7 Participants
|
449 participants
n=5 Participants
|
|
Preop Work Status
Yes
|
153 participants
n=5 Participants
|
309 participants
n=7 Participants
|
462 participants
n=5 Participants
|
|
Preop Work Status
No
|
71 participants
n=5 Participants
|
176 participants
n=7 Participants
|
247 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 months post-operationPopulation: Primary dataset (including all subjects who received study devices. Missing observations were not imputed.)
Rate of overall success is reported as the percentage of participants who met all of the following criteria: 1. fusion at the treated level; 2. pain/disability (Neck Disability Index) success; 3. neurological status success; 4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated;" 5. no additional surgical procedure classified as a "failure."
Outcome measures
| Measure |
INFUSE® Bone Graft
n=162 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=352 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Rate of Overall Success
|
80.9 percentage of participants
|
59.9 percentage of participants
|
SECONDARY outcome
Timeframe: 24 months post-operationPopulation: Primary dataset.
Success Rate of Fusion is reported as percent of participants who met the following fusion criteria: 1. Evidence of bridging bone. This is based on the evidence of a continuous bony connection from the superior vertebral body to the inferior vertebral body in at least one of the following areas: lateral, anterior, posterior and/or through the PEEK spacer. 2. No evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface. 3. No evidence of motion as defined by ≤ 4º of angular motion (based on flexion-extension lateral plain radiographs).
Outcome measures
| Measure |
INFUSE® Bone Graft
n=160 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=345 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Success Rate of Fusion
|
99.4 percentage of participants
|
87.2 percentage of participants
|
SECONDARY outcome
Timeframe: 24 months post-operationPopulation: Primary dataset.
Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.
Outcome measures
| Measure |
INFUSE® Bone Graft
n=176 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=413 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Success Rate of Neck Disability Index
|
85.8 percentage of participants
|
79.9 percentage of participants
|
SECONDARY outcome
Timeframe: 24 months post-operationPopulation: Primary dataset.
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 remain the same or improve from the time of the preoperative evaluation to the time period evaluated.
Outcome measures
| Measure |
INFUSE® Bone Graft
n=177 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=414 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Success Rate of Neurological Status
|
93.8 percentage of participants
|
85.0 percentage of participants
|
SECONDARY outcome
Timeframe: 24 months post-operationPopulation: Primary dataset.
Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score \> 0.
Outcome measures
| Measure |
INFUSE® Bone Graft
n=175 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=413 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Neck Pain Success Rate
|
96.0 percentage of participants
|
92.7 percentage of participants
|
SECONDARY outcome
Timeframe: 24 months post-operationPopulation: Primary dataset.
Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score \> 0.
Outcome measures
| Measure |
INFUSE® Bone Graft
n=175 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=413 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Arm Pain Success Rate
|
90.9 percentage of participants
|
88.6 percentage of participants
|
SECONDARY outcome
Timeframe: 24 months post-operationPopulation: Primary dataset.
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 rate of SF-36 PCS was defined as: Post Score - Pre Score \>= 0.
Outcome measures
| Measure |
INFUSE® Bone Graft
n=176 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=407 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Success Rate of SF-36 PCS
|
89.8 percentage of participants
|
88.2 percentage of participants
|
SECONDARY outcome
Timeframe: 24 months post-operationPopulation: Primary dataset.
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 rates of SF-36 MCS were defined as: Post Score - Pre Score \>= 0.
Outcome measures
| Measure |
INFUSE® Bone Graft
n=176 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=407 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Success Rate of SF-36 MCS
|
75.0 percentage of participants
|
71.3 percentage of participants
|
SECONDARY outcome
Timeframe: Time of operation, approximately 1.5 hrs.Population: Primary dataset.
Operative time was recorded from skin incision to wound closure.
Outcome measures
| Measure |
INFUSE® Bone Graft
n=224 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=486 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Operative Time
|
1.0 hrs
Standard Deviation 0.5
|
1.4 hrs
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: During the time of operation, approximately 1.5 hours.Population: Primary dataset.
Outcome measures
| Measure |
INFUSE® Bone Graft
n=224 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=484 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Blood Loss
|
40.1 ml
Standard Deviation 54.1
|
58.4 ml
Standard Deviation 59.9
|
SECONDARY outcome
Timeframe: During the time of hospital stay, average of 1 day.Population: Primary dataset.
Outcome measures
| Measure |
INFUSE® Bone Graft
n=224 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=486 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Hospital Stay
|
1.0 days
Standard Deviation 0.7
|
1.0 days
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 24 months post-operationSecondary surgical procedures at the index level included revisions, removal, supplemental fixation and reoperations.
Outcome measures
| Measure |
INFUSE® Bone Graft
n=224 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=486 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Number of Patients Who Had Secondary Surgeries at the Index Level
|
6 participants
|
27 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 months post-operationPopulation: Primary dataset.
The 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).
Outcome measures
| Measure |
INFUSE® Bone Graft
n=176 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=413 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Neck Disability Index Score
NDI at baseline
|
50.2 units on a scale
Standard Deviation 14.3
|
53.5 units on a scale
Standard Deviation 16.2
|
|
Neck Disability Index Score
NDI at 24 months
|
14.6 units on a scale
Standard Deviation 17.1
|
20.9 units on a scale
Standard Deviation 16.0
|
|
Neck Disability Index Score
NDI change at 24 months from baseline
|
-34.9 units on a scale
Standard Deviation 17.3
|
-32.3 units on a scale
Standard Deviation 20.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 months post-operationPopulation: Primary dataset.
Numerical rating scales are used to evaluate neck pain intensity and frequency. Patients rate 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, patients record 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 is the sum of pain intensity and frequency scores.
Outcome measures
| Measure |
INFUSE® Bone Graft
n=175 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=413 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Neck Pain Score
Neck pain at 24 months
|
4.5 units on a scale
Standard Deviation 5.2
|
6.0 units on a scale
Standard Deviation 6.9
|
|
Neck Pain Score
Neck pain change at 24 months from baseline
|
-11.2 units on a scale
Standard Deviation 5.3
|
-9.8 units on a scale
Standard Deviation 7.2
|
|
Neck Pain Score
Neck pain at baseline
|
15.9 units on a scale
Standard Deviation 2.7
|
15.8 units on a scale
Standard Deviation 3.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 months post-operationPopulation: Primary dataset.
Numerical rating scales are used to evaluate arm pain intensity and frequency. Patients rate 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, patients record 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 will be the sum of pain intensity and frequency scores.
Outcome measures
| Measure |
INFUSE® Bone Graft
n=175 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=413 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Arm Pain Score
Arm pain at baseline
|
13.5 units on a scale
Standard Deviation 5.1
|
14.8 units on a scale
Standard Deviation 4.7
|
|
Arm Pain Score
Arm pain at 24 months
|
3.6 units on a scale
Standard Deviation 4.9
|
4.7 units on a scale
Standard Deviation 5.8
|
|
Arm Pain Score
Arm pain change at 24 months from baseline
|
-10.1 units on a scale
Standard Deviation 6.3
|
-10.1 units on a scale
Standard Deviation 6.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 months post-operationPopulation: Primary dataset.
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.
Outcome measures
| Measure |
INFUSE® Bone Graft
n=176 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=407 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
General Health Status -- SF-36 PCS
SF-36 PCS at baseline
|
31.6 units on a scale
Standard Deviation 6.6
|
31.9 units on a scale
Standard Deviation 7.3
|
|
General Health Status -- SF-36 PCS
SF-36 PCS at 24 months
|
47.7 units on a scale
Standard Deviation 11.1
|
45.3 units on a scale
Standard Deviation 11.5
|
|
General Health Status -- SF-36 PCS
SF-36 PCS change at 24 months from baseline
|
15.6 units on a scale
Standard Deviation 10.9
|
13.1 units on a scale
Standard Deviation 11.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 months post-operationPopulation: Primary dataset.
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS is between 0 and 100, with higher scores denoting better quality of life.
Outcome measures
| Measure |
INFUSE® Bone Graft
n=176 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=407 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
General Health Status -- SF-36 MCS
SF-36 MCS at baseline
|
43.6 units on a scale
Standard Deviation 12.0
|
43.6 units on a scale
Standard Deviation 12.1
|
|
General Health Status -- SF-36 MCS
SF-36 MCS at 24 months
|
51.8 units on a scale
Standard Deviation 9.5
|
50.9 units on a scale
Standard Deviation 10.8
|
|
General Health Status -- SF-36 MCS
SF-36 MCS Change at 24 months from baseline
|
8.0 units on a scale
Standard Deviation 12.0
|
7.2 units on a scale
Standard Deviation 13.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 months post-operationPopulation: Primary dataset.
Ossification in the region of target level is reported as the percentage of the patients who had ossification in the region of the target level. The region of target level included the index level, the superior and inferior adjacent disc spaces, and the superior and inferior adjacent vertebral bodies.
Outcome measures
| Measure |
INFUSE® Bone Graft
n=224 Participants
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=486 Participants
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Ossification in the Region of Target Level
Preoperative (n=220, 442)
|
40.9 percentage of participants
|
36.9 percentage of participants
|
|
Ossification in the Region of Target Level
24 months (n=168, 407)
|
78.6 percentage of participants
|
59.2 percentage of participants
|
Adverse Events
INFUSE® Bone Graft
Serious events: 71 serious events
Other events: 186 other events
Deaths: 0 deaths
Historical Control
Serious events: 159 serious events
Other events: 371 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
INFUSE® Bone Graft
n=224 participants at risk
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=486 participants at risk
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Cardiac disorders
Acute Myoccardial Infarction
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Cardiac disorders
Cardiac Arrest
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Cardiac disorders
Cardiogenic Shock
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Cardiac disorders
Cardiomegaly
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Cardiac disorders
Coronary Artery Disease
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Cardiac disorders
Palpitations
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Endocrine disorders
Autoimmune Thyroiditis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Endocrine disorders
Hypothyroidism
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Endocrine disorders
Thyroid Cyst
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Eye disorders
Astigmatism
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Eye disorders
Cataract
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Eye disorders
Ectropion
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Eye disorders
Lacrimation Increased
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Eye disorders
Visual Impairment
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Gastrointestinal Ulcer
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Nausea
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Oesophageal Fistula
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Proctalgia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
General disorders
Accidental Death
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
General disorders
Adverse Drug Reaction
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
General disorders
Asthenia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
General disorders
Axillary Pain
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
General disorders
Chest Discomfort
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
General disorders
Chest Pain
|
0.00%
0/224 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
General disorders
Device Breakage
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
General disorders
Drug Withdrawal Syndrome
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
General disorders
Facial Pain
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
General disorders
Gait Disturbance
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
General disorders
Hernia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
General disorders
Local Swelling
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
General disorders
Non-Cardiac Chest Pain
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
General disorders
Oedema Peripheral
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
General disorders
Pain
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
General disorders
Pyrexia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
General disorders
Soft Tissue Inflammation
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
General disorders
Spinal Pain
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Hepatobiliary disorders
Gallbladder Disorder
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Immune system disorders
Immunodeficiency Common Variable
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Immune system disorders
Sarcoidosis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Infections and infestations
Bacterial Sepsis
|
0.45%
1/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Infections and infestations
Extradural Abscess
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Infections and infestations
Kidney Infection
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Infections and infestations
Meningitis Herpes
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Paraoesophageal Abscess
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Pneumonia Primary Atypical
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Infections and infestations
Pyelonephritis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Sepsis
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Infections and infestations
Wound Infection
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Accident At Work
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Bone Fragmentation
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Epidural Fibrosis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Eye Injury
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
4/224 • Number of events 5 • Up to 24 months
|
1.2%
6/486 • Number of events 6 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Gastrointestinal Anastomotic Leak
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Intervertebral Disc Injury
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Meniscus Lesion
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.82%
4/486 • Number of events 4 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Multiple Drug Overdose Accidental
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Nerve Injury
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Post Laminectomy Syndrome
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Post-Traumatic Neck Syndrome
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural Haemorrhage
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural Headache
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Pubis Fracture
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
2.7%
6/224 • Number of events 6 • Up to 24 months
|
1.0%
5/486 • Number of events 5 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/224 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Tracheal Deviation
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Investigations
Pancreatic Enzymes Increased
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Investigations
White Blood Cell Count Increased
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.41%
2/486 • Number of events 4 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/224 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.7%
6/224 • Number of events 6 • Up to 24 months
|
1.6%
8/486 • Number of events 8 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
3.1%
15/486 • Number of events 15 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Compartment Syndrome
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
2.5%
12/486 • Number of events 16 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Facet Joint Syndrome
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
4.0%
9/224 • Number of events 9 • Up to 24 months
|
3.7%
18/486 • Number of events 18 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorder
|
1.8%
4/224 • Number of events 4 • Up to 24 months
|
0.82%
4/486 • Number of events 4 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
6.7%
15/224 • Number of events 15 • Up to 24 months
|
6.6%
32/486 • Number of events 35 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Space Narrowing
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint Crepitation
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Ligament Disorder
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
1.8%
4/224 • Number of events 4 • Up to 24 months
|
2.1%
10/486 • Number of events 10 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.82%
4/486 • Number of events 4 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
2.3%
11/486 • Number of events 13 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.7%
6/224 • Number of events 7 • Up to 24 months
|
3.3%
16/486 • Number of events 18 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.3%
3/224 • Number of events 5 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
1.9%
9/486 • Number of events 9 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
3.3%
16/486 • Number of events 16 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
2.2%
5/224 • Number of events 6 • Up to 24 months
|
2.3%
11/486 • Number of events 12 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
2.2%
5/224 • Number of events 5 • Up to 24 months
|
1.6%
8/486 • Number of events 8 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
1.8%
4/224 • Number of events 4 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 2 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Tendon Disorder
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Trigger Finger
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Vertebral Foraminal Stenosis
|
2.2%
5/224 • Number of events 5 • Up to 24 months
|
0.82%
4/486 • Number of events 4 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous Histiocytoma
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myolipoma
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Cancer
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Adenoma
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Amnesia
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Arachnoid Cyst
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Burning Sensation
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
2.1%
10/486 • Number of events 10 • Up to 24 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Cervical Cord Compression
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Cervicobrachial Syndrome
|
0.00%
0/224 • Up to 24 months
|
1.4%
7/486 • Number of events 7 • Up to 24 months
|
|
Nervous system disorders
Convulsion
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 2 • Up to 24 months
|
|
Nervous system disorders
Dysaesthesia
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Nervous system disorders
Headache
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
1.0%
5/486 • Number of events 5 • Up to 24 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
1.6%
8/486 • Number of events 9 • Up to 24 months
|
|
Nervous system disorders
Hypokinesia
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Hypoxic-Ischaemic Encephalopathy
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Loss Of Consciousness
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Nervous system disorders
Migraine
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Myelitis Transverse
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Myelopathy
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Nerve Root Compression
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Nervous system disorders
Paraesthesia
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.82%
4/486 • Number of events 4 • Up to 24 months
|
|
Nervous system disorders
Perineurial Cyst
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Radicular Pain
|
0.00%
0/224 • Up to 24 months
|
1.4%
7/486 • Number of events 7 • Up to 24 months
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Sciatica
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Sensory Loss
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Spinal Cord Compression
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Nervous system disorders
Spinal Cord Ischaemia
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Spinal Cord Oedema
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Syncope
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Thoracic Outlet Syndrome
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 2 • Up to 24 months
|
|
Nervous system disorders
Ulnar Nerve Palsy
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Pregnancy, puerperium and perinatal conditions
Foetal Hypokinesia
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Pregnancy, puerperium and perinatal conditions
Premature Labour
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Psychiatric disorders
Abnormal Behaviour
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Psychiatric disorders
Alcohol Abuse
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Psychiatric disorders
Anxiety
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Psychiatric disorders
Depression
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Psychiatric disorders
Schizophrenia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Psychiatric disorders
Stress
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Psychiatric disorders
Suicidal Behaviour
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Renal and urinary disorders
Calculus Ureteric
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Renal and urinary disorders
Cystitis Interstitial
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Renal and urinary disorders
Neurogenic Bladder
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Reproductive system and breast disorders
Prostatitis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Reproductive system and breast disorders
Scrotal Pain
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Reproductive system and breast disorders
Testicular Torsion
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Reproductive system and breast disorders
Foreign Body Aspiration
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Haematoma
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Sarcoidosis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Vocal Cord Polyp
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Keloid Scar
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Surgical and medical procedures
Face Lift
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Surgical and medical procedures
Gastric Bypass
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Surgical and medical procedures
Venous Operation
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Vascular disorders
Aortic Stenosis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Vascular disorders
Haematoma
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Vascular disorders
Hypertension
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Vascular disorders
Hypotension
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Vascular disorders
Orthostatic Hypertension
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Vascular disorders
Peripheral Artery Aneurysm
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
Other adverse events
| Measure |
INFUSE® Bone Graft
n=224 participants at risk
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
|
Historical Control
n=486 participants at risk
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
1.8%
4/224 • Number of events 4 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.45%
1/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.8%
4/224 • Number of events 4 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/224 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Cardiac disorders
Arrhythmia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Cardiac disorders
Bradycardia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Cardiac disorders
Coronary Artery Disease
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/224 • Up to 24 months
|
1.0%
5/486 • Number of events 5 • Up to 24 months
|
|
Cardiac disorders
Sinus Bradycardia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Cardiac disorders
Sinus Tachycardia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Ear and labyrinth disorders
Ear Pain
|
1.8%
4/224 • Number of events 4 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Ear and labyrinth disorders
Hearing Impaired
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Ear and labyrinth disorders
Vestibular Disorder
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Endocrine disorders
Autoimmune Thyroiditis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Endocrine disorders
Goitre
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Endocrine disorders
Hypothyroidism
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Eye disorders
Astigmatism
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Eye disorders
Cataract
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Eye disorders
Conjunctivitis
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Eye disorders
Diplopia
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Eye disorders
Eye Pain
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Eye disorders
Photophobia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Eye disorders
Vision Blurred
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Eye disorders
Visual Impairment
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Eye disorders
Vitreous Floaters
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Abdominal Adhesions
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Breath Odour
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Change Of Bowel Habit
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Constipation
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
5/224 • Number of events 5 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Dysphagia
|
15.2%
34/224 • Number of events 37 • Up to 24 months
|
7.0%
34/486 • Number of events 36 • Up to 24 months
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Eructation
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Faecal Incontinence
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Gastritis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
1.8%
4/224 • Number of events 4 • Up to 24 months
|
1.4%
7/486 • Number of events 7 • Up to 24 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Intestinal Polyp
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Malocclusion
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Nausea
|
3.6%
8/224 • Number of events 8 • Up to 24 months
|
1.6%
8/486 • Number of events 8 • Up to 24 months
|
|
Gastrointestinal disorders
Odynophagia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Oesophageal Oedema
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Periodontal Disease
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Polyp Colorectal
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Tongue Discolouration
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
4/224 • Number of events 4 • Up to 24 months
|
1.0%
5/486 • Number of events 5 • Up to 24 months
|
|
General disorders
Adverse Drug Reaction
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
General disorders
Asthenia
|
2.2%
5/224 • Number of events 6 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
General disorders
Axillary Pain
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
General disorders
Chest Discomfort
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
General disorders
Chest Pain
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
2.1%
10/486 • Number of events 10 • Up to 24 months
|
|
General disorders
Chills
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
General disorders
Crepitations
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
General disorders
Device Breakage
|
0.00%
0/224 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
General disorders
Device Connection Issue
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
General disorders
Device Dislocation
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
General disorders
Drug Withdrawal Syndrome
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
General disorders
Facial Pain
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
General disorders
Fatigue
|
2.7%
6/224 • Number of events 6 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
General disorders
Feeling Cold
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
General disorders
Gait Disturbance
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
General disorders
Implant Site Paraesthesia
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
General disorders
Infusion Site Extravasation
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
General disorders
Irritability
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
General disorders
Local Swelling
|
3.1%
7/224 • Number of events 7 • Up to 24 months
|
0.82%
4/486 • Number of events 4 • Up to 24 months
|
|
General disorders
Malaise
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
General disorders
Non-Cardiac Chest Pain
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
General disorders
Oedema Peripheral
|
1.8%
4/224 • Number of events 5 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
General disorders
Pain
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
General disorders
Pyrexia
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
General disorders
Sensation Of Foreign Body
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
General disorders
Sensation Of Pressure
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
General disorders
Spinal Pain
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
General disorders
Swelling
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Immune system disorders
Hypersensitivity
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Immune system disorders
Latex Allergy
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Immune system disorders
Seasonal Allergy
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Infections and infestations
Adenoviral Conjunctivitis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Breast Abscess
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Ear Infection
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Gastroenteritis Viral
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Gastrointestinal Bacterial Infection
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Herpes Zoster
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Hordeolum
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Incision Site Infection
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Infections and infestations
Influenza
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.62%
3/486 • Number of events 4 • Up to 24 months
|
|
Infections and infestations
Kidney Infection
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Infections and infestations
Laryngitis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Otitis Media
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Pertussis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Pneumonia
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Pneumonia Primary Atypical
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Post Procedural Infection
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Reiter's Syndrome
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Rhinitis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Infections and infestations
Sinusitis
|
2.7%
6/224 • Number of events 6 • Up to 24 months
|
1.0%
5/486 • Number of events 5 • Up to 24 months
|
|
Infections and infestations
Staphylococcal Infection
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Stitch Abscess
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Infections and infestations
Tonsillitis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Infections and infestations
Tracheitis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.45%
1/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Dural Tear
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Electric Shock
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Endotracheal Intubation Complication
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.82%
4/486 • Number of events 4 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Face Injury
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
4.5%
10/224 • Number of events 10 • Up to 24 months
|
5.6%
27/486 • Number of events 28 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Foreign Body
|
0.45%
1/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Graft Complication
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/224 • Up to 24 months
|
1.0%
5/486 • Number of events 6 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Incision Site Complication
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Incision Site Erythema
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Incision Site Haematoma
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Incision Site Oedema
|
3.6%
8/224 • Number of events 8 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Incorrect Dose Administered
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Intervertebral Disc Injury
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.82%
4/486 • Number of events 4 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Limb Crushing Injury
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Meniscus Lesion
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
2.2%
5/224 • Number of events 5 • Up to 24 months
|
1.4%
7/486 • Number of events 7 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Nail Avulsion
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Neck Injury
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Periorbital Haematoma
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Post Laminectomy Syndrome
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Post Procedural Constipation
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Post-Traumatic Neck Syndrome
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural Dizziness
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural Haemorrhage
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural Headache
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural Hypertension
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
0.00%
0/224 • Up to 24 months
|
1.0%
5/486 • Number of events 5 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural Vomiting
|
0.00%
0/224 • Up to 24 months
|
1.0%
5/486 • Number of events 5 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
3.1%
7/224 • Number of events 7 • Up to 24 months
|
3.1%
15/486 • Number of events 15 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Spondylopathy Traumatic
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Sports Injury
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Toxicity To Various Agents
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Tracheal Deviation
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Wound Contamination
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Investigations
Blood Cholesterol Increased
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Investigations
Blood Pressure Increased
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Investigations
Blood Sodium Decreased
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Blood Triglycerides Increased
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Investigations
Colonoscopy
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Investigations
Electrocardiogram T Wave Abnormal
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Investigations
Haematocrit Decreased
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Investigations
Haemoglobin Decreased
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Investigations
Heart Rate Increased
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Investigations
Intraocular Pressure Test Abnormal
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Investigations
Oxygen Saturation Decreased
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Investigations
Red Blood Cell Sedimentation Rate Increased
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Investigations
Reflex Test Abnormal
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Investigations
Sleep Study Abnormal
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Investigations
Transaminases Increased
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Investigations
Urine Output Decreased
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Investigations
Weight Decreased
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Investigations
White Blood Cell Count Increased
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Investigations
Gout
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/224 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
1.0%
5/486 • Number of events 5 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Ankylosing Spondylitis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
7/224 • Number of events 7 • Up to 24 months
|
2.9%
14/486 • Number of events 14 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.9%
29/224 • Number of events 34 • Up to 24 months
|
9.1%
44/486 • Number of events 47 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Bone Cyst
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Bone Deformity
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.2%
5/224 • Number of events 5 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
1.2%
6/486 • Number of events 6 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
3.1%
7/224 • Number of events 7 • Up to 24 months
|
2.5%
12/486 • Number of events 13 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Facet Joint Syndrome
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.82%
4/486 • Number of events 4 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
5.4%
12/224 • Number of events 15 • Up to 24 months
|
4.1%
20/486 • Number of events 21 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorder
|
1.8%
4/224 • Number of events 4 • Up to 24 months
|
0.82%
4/486 • Number of events 4 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
8.0%
18/224 • Number of events 21 • Up to 24 months
|
5.3%
26/486 • Number of events 27 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Space Narrowing
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint Crepitation
|
2.2%
5/224 • Number of events 5 • Up to 24 months
|
0.62%
3/486 • Number of events 4 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint Hyperextension
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint Laxity
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint Lock
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased
|
0.00%
0/224 • Up to 24 months
|
0.82%
4/486 • Number of events 4 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Meniscal Degeneration
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Atrophy
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Fatigue
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
9.4%
21/224 • Number of events 24 • Up to 24 months
|
8.2%
40/486 • Number of events 46 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
1.8%
4/224 • Number of events 5 • Up to 24 months
|
2.3%
11/486 • Number of events 13 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
1.8%
4/224 • Number of events 4 • Up to 24 months
|
2.1%
10/486 • Number of events 12 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
4.9%
11/224 • Number of events 13 • Up to 24 months
|
2.3%
11/486 • Number of events 12 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
16.5%
37/224 • Number of events 42 • Up to 24 months
|
13.8%
67/486 • Number of events 77 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
4.0%
9/224 • Number of events 10 • Up to 24 months
|
4.3%
21/486 • Number of events 24 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
4.9%
24/486 • Number of events 27 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myofascial Pain Syndrome
|
0.00%
0/224 • Up to 24 months
|
1.0%
5/486 • Number of events 5 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myofascial Spasm
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Neck Mass
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
28.1%
63/224 • Number of events 68 • Up to 24 months
|
21.8%
106/486 • Number of events 122 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
1.0%
5/486 • Number of events 6 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteochondritis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
14.7%
33/224 • Number of events 37 • Up to 24 months
|
13.2%
64/486 • Number of events 72 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral Pain Syndrome
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Plantar Fasciitis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/224 • Up to 24 months
|
6.0%
29/486 • Number of events 29 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
3.1%
7/224 • Number of events 7 • Up to 24 months
|
2.1%
10/486 • Number of events 10 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Sensation Of Heaviness
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Disorder
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
4.5%
10/224 • Number of events 12 • Up to 24 months
|
2.3%
11/486 • Number of events 16 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular Joint Syndrome
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.82%
4/486 • Number of events 4 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
1.8%
4/224 • Number of events 4 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Trigger Finger
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Vertebral Foraminal Stenosis
|
4.0%
9/224 • Number of events 9 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous Cortical Defect
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic Naevus
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nervous System Neoplasm
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal Haemangioma
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Neoplasm
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Allodynia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Amnesia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Arachnoid Cyst
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Balance Disorder
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Burning Sensation
|
1.8%
4/224 • Number of events 4 • Up to 24 months
|
1.4%
7/486 • Number of events 7 • Up to 24 months
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
4.5%
10/224 • Number of events 10 • Up to 24 months
|
3.3%
16/486 • Number of events 16 • Up to 24 months
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Cervical Myelopathy
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Cervicobrachial Syndrome
|
0.00%
0/224 • Up to 24 months
|
1.0%
5/486 • Number of events 5 • Up to 24 months
|
|
Nervous system disorders
Cervicogenic Headache
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Coordination Abnormal
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Cubital Tunnel Syndrome
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Dizziness
|
3.1%
7/224 • Number of events 7 • Up to 24 months
|
1.4%
7/486 • Number of events 8 • Up to 24 months
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Dysaesthesia
|
1.8%
4/224 • Number of events 4 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Headache
|
11.2%
25/224 • Number of events 26 • Up to 24 months
|
8.0%
39/486 • Number of events 41 • Up to 24 months
|
|
Nervous system disorders
Horner's Syndrome
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Hyperaesthesia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Hyperpathia
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Hyperreflexia
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Nervous system disorders
Hypersomnia
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Hypoaesthesia
|
15.2%
34/224 • Number of events 42 • Up to 24 months
|
14.6%
71/486 • Number of events 97 • Up to 24 months
|
|
Nervous system disorders
Intracranial Hypotension
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Loss Of Consciousness
|
0.00%
0/224 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Nervous system disorders
Migraine
|
2.2%
5/224 • Number of events 5 • Up to 24 months
|
1.2%
6/486 • Number of events 6 • Up to 24 months
|
|
Nervous system disorders
Muscle Contractions Involuntary
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/224 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Nervous system disorders
Narcolepsy
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Nerve Compression
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Nervous system disorders
Nerve Root Compression
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Nervous system disorders
Nervous System Disorder
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Neuralgia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Neuritis
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Paraesthesia
|
9.4%
21/224 • Number of events 25 • Up to 24 months
|
9.3%
45/486 • Number of events 51 • Up to 24 months
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Piriformis Syndrome
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Poor Quality Sleep
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Post-Traumatic Headache
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Radicular Pain
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
4.3%
21/486 • Number of events 21 • Up to 24 months
|
|
Nervous system disorders
Radicular Syndrome
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Radiculopathy
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Restless Legs Syndrome
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Sciatica
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Nervous system disorders
Sensory Disturbance
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Nervous system disorders
Sensory Loss
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
1.0%
5/486 • Number of events 5 • Up to 24 months
|
|
Nervous system disorders
Sinus Headache
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Spinal Cord Disorder
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Syncope
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Nervous system disorders
Tension Headache
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Thoracic Outlet Syndrome
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Nervous system disorders
Tremor
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Nervous system disorders
Ulnar Neuritis
|
0.00%
0/224 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Nervous system disorders
Viith Nerve Paralysis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Nervous system disorders
Vocal Cord Paralysis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Pregnancy, puerperium and perinatal conditions
Gestational Diabetes
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Psychiatric disorders
Affect Lability
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Psychiatric disorders
Anxiety
|
1.8%
4/224 • Number of events 4 • Up to 24 months
|
1.4%
7/486 • Number of events 8 • Up to 24 months
|
|
Psychiatric disorders
Bipolar I Disorder
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Psychiatric disorders
Confusional State
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Psychiatric disorders
Delirium
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Psychiatric disorders
Depression
|
4.5%
10/224 • Number of events 10 • Up to 24 months
|
2.1%
10/486 • Number of events 10 • Up to 24 months
|
|
Psychiatric disorders
Disorientation
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Psychiatric disorders
Insomnia
|
3.6%
8/224 • Number of events 8 • Up to 24 months
|
1.4%
7/486 • Number of events 7 • Up to 24 months
|
|
Psychiatric disorders
Libido Decreased
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Psychiatric disorders
Mood Swings
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Psychiatric disorders
Panic Attack
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Psychiatric disorders
Sleep Disorder
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Psychiatric disorders
Stress
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Renal and urinary disorders
Dysuria
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Renal and urinary disorders
Enuresis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Renal and urinary disorders
Hydroureter
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.8%
4/224 • Number of events 4 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/224 • Up to 24 months
|
0.82%
4/486 • Number of events 4 • Up to 24 months
|
|
Renal and urinary disorders
Urinary Retention
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Reproductive system and breast disorders
Breast Mass
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Reproductive system and breast disorders
Menopausal Symptoms
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Hyperreactivity
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
4/224 • Number of events 4 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.3%
3/224 • Number of events 4 • Up to 24 months
|
1.2%
6/486 • Number of events 6 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
5/224 • Number of events 5 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Increased Upper Airway Secretion
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Erythema
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Oedema
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Cyst
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Inflammation
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Discomfort
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.1%
7/224 • Number of events 7 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Painful Respiration
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Disorder
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Oedema
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
0.89%
2/224 • Number of events 3 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Disorder
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.00%
0/224 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
1.3%
3/224 • Number of events 3 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat Tightness
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Vocal Cord Thickening
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Exfoliative
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.00%
0/224 • Up to 24 months
|
0.62%
3/486 • Number of events 3 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Leukoplakia
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.00%
0/224 • Up to 24 months
|
0.41%
2/486 • Number of events 2 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Skin Burning Sensation
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Social circumstances
Physical Assault
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Surgical and medical procedures
Arthrodesis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Surgical and medical procedures
Suture Removal
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Vascular disorders
Flushing
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
|
Vascular disorders
Haematoma
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Vascular disorders
Hypertension
|
2.2%
5/224 • Number of events 5 • Up to 24 months
|
1.2%
6/486 • Number of events 6 • Up to 24 months
|
|
Vascular disorders
Hypotension
|
0.45%
1/224 • Number of events 1 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Vascular disorders
Peripheral Coldness
|
0.00%
0/224 • Up to 24 months
|
0.21%
1/486 • Number of events 1 • Up to 24 months
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.89%
2/224 • Number of events 2 • Up to 24 months
|
0.00%
0/486 • Up to 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60